Trial Outcomes & Findings for Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and Postpartum (NCT NCT04518228)

Last Updated: 2026-08-26

Results Overview

A target AUC was derived for each drug as the 10th percentile for the non-pregnant population based on historical control data. The target AUC is 58.7 mg\*h/L for Arm 1.1 and 10.0 mg\*h/L for Arm 1.2. Pharmacokinetic parameters were determined by the study pharmacologists from plasma concentration-time profiles using noncompartmental methods. McNemar's test was not conducted for Arm 1.2 due to low sample size.

Recruitment status

TERMINATED

Target enrollment

205 participants

Primary outcome timeframe

Measured at 2nd trimester (2T, 20 0/7 - 26 6/7 weeks of pregnancy), 3rd trimester (3T, 30 0/7 - 37 6/7 weeks of pregnancy), and postpartum (PP, 6-12 weeks after delivery). Sampling performed pre-dose and at 1, 2, 4, 6, 8, 12, and 24 hours post-dose.

Results posted on

2026-08-26

Participant Flow

Participants enrolled between 1Sep2021 and 28Nov2024 at US and non-US clinical research sites and could enroll in multiple arms, simultaneously; thus, reporting groups are not mutually exclusive and totals do not reflect the number of unique participants. There were 205 unique participants (102 mothers and 103 infants), including14 mother-infant pairs enrolled in both Arm 1.1 and 1.4. There were no reporting group changes during the study.

Started, Completed, and Not Completed rows refer to maternal + fetus/infant study status. Infants in Components 1-4 were enrolled in utero at the same time as maternal enrollment per protocol.

Participant milestones

Participant milestones
Measure	Component 1: Arm 1.1: Bictegravir (BIC) 50 mg q.d. Women ≥ 20 weeks gestation not receiving TB drugs and receiving bictegravir (BIC) 50 mg once daily (q.d.), and their infants	Component 1: Arm 1.2: Doravirine (DOR) 100 mg q.d. Women ≥ 20 weeks gestation not receiving TB drugs and receiving doravirine (DOR) 100 mg q.d., and their infants	Component 1: Arm 1.3: Tenofovir Alafenamide (TAF) 10 mg q.d. Boosted With Cobicistat Women ≥ 20 weeks gestation not receiving TB drugs and receiving tenofovir alafenamide (TAF) 10 mg q.d. boosted with cobicistat, and their infants	Component 1: Arm 1.4: TAF 25 mg q.d. Without Boosting Women ≥ 20 weeks gestation not receiving TB drugs and receiving TAF 25 mg q.d. without boosting, and their infants	Component 3: Arm 3.1: First-line TB Treatment Drugs and Dolutegravir (DTG) 50 mg Women ≥ 20 weeks gestation receiving first-line TB treatment with at least two of the following TB treatment drugs: isoniazid (INH), rifampin (RIF), rifabutin (RFB), ethambutol (EMB), pyrazinamide (PZA), moxifloxacin (MFX), and receiving dolutegravir (DTG) 50 mg twice daily (b.i.d.) when combined with RIF or 50 mg q.d. if RIF is not part of the TB regimen, and their infants	Component 4: Arm 4.1: Second-line TB Treatment Drugs Women ≥ 20 weeks gestation receiving at least one of the following second-line TB treatment drugs, and their infants: * Levofloxacin (LFX) 750mg - 1000mg q.d. * Clofazimine (CFZ) 100mg q.d. * Linezolid (LZD) 300mg - 600mg q.d. * Bedaquiline (BDQ) 200mg three times per week (t.i.w.) * Delamanid (DLM) 100mg b.i.d. * Moxifloxacin (MFX) 400mg or 800mg q.d., and at least one other second-line TB treatment drug under study	Component 5: Arm 5.1: ATV/r While Breastfeeding Women post-delivery receiving ATV/r, and their infants
Overall Study STARTED	54	8	27	56	46	14	28
Overall Study Mother Started	27	4	13	28	23	7	14
Overall Study Mother Completed	24	3	12	27	23	5	14
Overall Study Mother Not Completed	3	1	1	1	0	2	0
Overall Study Mother Reason Not Completed: Lost to Follow-Up	1	0	0	0	0	1	0
Overall Study Mother Reason Not Completed: Withdrawal by Subject	2	1	0	1	0	1	0
Overall Study Mother Reason Not Completed: Participant Refusal	0	0	1	0	0	0	0
Overall Study Infant In Utero Enrollment	27	4	14	28	23	7	0
Overall Study Infant Started	26	4	13	28	23	6	14
Overall Study Infant Completed	24	3	13	26	23	5	14
Overall Study Infant Not Completed	3	1	1	2	0	2	0
Overall Study Infant Reason Not Completed: Lost to Follow-up	1	0	0	1	0	1	0
Overall Study Infant Reason Not Completed: Withdrawal by Parent/Guardian	1	1	0	1	0	1	0
Overall Study Infant Reason Not Completed: Parent/Guardian Refusal	1	0	1	0	0	0	0
Overall Study COMPLETED	48	6	25	53	46	10	28
Overall Study NOT COMPLETED	6	2	2	3	0	4	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Component 1: Arm 1.1: Bictegravir (BIC) 50 mg q.d. Women ≥ 20 weeks gestation not receiving TB drugs and receiving bictegravir (BIC) 50 mg once daily (q.d.), and their infants	Component 1: Arm 1.2: Doravirine (DOR) 100 mg q.d. Women ≥ 20 weeks gestation not receiving TB drugs and receiving doravirine (DOR) 100 mg q.d., and their infants	Component 1: Arm 1.3: Tenofovir Alafenamide (TAF) 10 mg q.d. Boosted With Cobicistat Women ≥ 20 weeks gestation not receiving TB drugs and receiving tenofovir alafenamide (TAF) 10 mg q.d. boosted with cobicistat, and their infants	Component 1: Arm 1.4: TAF 25 mg q.d. Without Boosting Women ≥ 20 weeks gestation not receiving TB drugs and receiving TAF 25 mg q.d. without boosting, and their infants	Component 4: Arm 4.1: Second-line TB Treatment Drugs Women ≥ 20 weeks gestation receiving at least one of the following second-line TB treatment drugs, and their infants: * Levofloxacin (LFX) 750mg - 1000mg q.d. * Clofazimine (CFZ) 100mg q.d. * Linezolid (LZD) 300mg - 600mg q.d. * Bedaquiline (BDQ) 200mg three times per week (t.i.w.) * Delamanid (DLM) 100mg b.i.d. * Moxifloxacin (MFX) 400mg or 800mg q.d., and at least one other second-line TB treatment drug under study
Overall Study Lost to Follow-up	2	0	0	1	2
Overall Study Withdrawal by Subject	3	2	0	2	2
Overall Study Participant or Guardian Refusal	1	0	2	0	0

Baseline Characteristics

Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4). Age is reported in years for mothers and days for infants.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Component 1: Arm 1.1: Bictegravir (BIC) 50 mg q.d. n=27 Participants Women ≥ 20 weeks gestation not receiving TB drugs and receiving bictegravir (BIC) 50 mg once daily (q.d.)	Component 1: Arm 1.2: Doravirine (DOR) 100 mg q.d. n=4 Participants Women ≥ 20 weeks gestation not receiving TB drugs and receiving doravirine (DOR) 100 mg q.d.	Component 1: Arm 1.3: Tenofovir Alafenamide (TAF) 10 mg q.d. Boosted With Cobicistat n=13 Participants Women ≥ 20 weeks gestation not receiving TB drugs and receiving tenofovir alafenamide (TAF) 10 mg q.d. boosted with cobicistat	Component 1: Arm 1.4: TAF 25 mg q.d. Without Boosting n=28 Participants Women ≥ 20 weeks gestation not receiving TB drugs and receiving TAF 25 mg q.d. without boosting	Component 3: Arm 3.1: Dolutegravir (DTG) 50 mg n=23 Participants Women ≥ 20 weeks gestation receiving first-line TB treatment with at least two of the following TB treatment drugs: isoniazid (INH), rifampin (RIF), rifabutin (RFB), ethambutol (EMB), pyrazinamide (PZA), moxifloxacin (MFX), and receiving dolutegravir (DTG) 50 mg twice daily (b.i.d.) when combined with RIF or 50 mg q.d. if RIF is not part of the TB regimen	Component 4: Arm 4.1: Second-line TB Treatment Drugs n=7 Participants Women ≥ 20 weeks gestation receiving at least one of the following second-line TB treatment drugs: * Levofloxacin (LFX) 750mg - 1000mg q.d. * Clofazimine (CFZ) 100mg q.d. * Linezolid (LZD) 300mg - 600mg q.d. * Bedaquiline (BDQ) 200mg three times per week (t.i.w.) * Delamanid (DLM) 100mg b.i.d. * Moxifloxacin (MFX) 400mg or 800mg q.d., and at least one other second-line TB treatment drug under study	Component 5: Arm 5.1: ATV/r While Breastfeeding MOTHER n=14 Participants Women post-delivery receiving ATV/r	Component 5: Arm 5.1: ATV/r While Breastfeeding INFANT n=14 Participants Infants of women post-delivery receiving ATV/r	Total n=130 Participants Total of all reporting groups
Age, Continuous	31.7 years n=27 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4). Age is reported in years for mothers and days for infants.	28.0 years n=4 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4). Age is reported in years for mothers and days for infants.	29.0 years n=13 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4). Age is reported in years for mothers and days for infants.	28.8 years n=28 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4). Age is reported in years for mothers and days for infants.	31.4 years n=23 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4). Age is reported in years for mothers and days for infants.	29.2 years n=7 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4). Age is reported in years for mothers and days for infants.	29.6 years n=14 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4). Age is reported in years for mothers and days for infants.	7 days n=14 Participants • Age is reported in years for mothers and days for infants.	7 days n=14 Participants • Age is reported in years for mothers and days for infants.
Sex: Female, Male Female	27 Participants n=27 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	4 Participants n=4 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	13 Participants n=13 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	28 Participants n=28 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	23 Participants n=23 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	7 Participants n=7 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	14 Participants n=14 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	4 Participants n=14 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	120 Participants n=130 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).
Sex: Female, Male Male	0 Participants n=27 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	0 Participants n=4 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	0 Participants n=13 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	0 Participants n=28 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	0 Participants n=23 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	0 Participants n=7 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	0 Participants n=14 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	10 Participants n=14 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	10 Participants n=130 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=27 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	3 Participants n=4 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	5 Participants n=13 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	11 Participants n=28 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	5 Participants n=23 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	0 Participants n=7 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	0 Participants n=14 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	0 Participants n=14 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	32 Participants n=130 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=27 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	1 Participants n=4 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	8 Participants n=13 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	17 Participants n=28 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	17 Participants n=23 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	7 Participants n=7 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	14 Participants n=14 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	14 Participants n=14 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	97 Participants n=130 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=27 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	0 Participants n=4 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	0 Participants n=13 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	0 Participants n=28 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	1 Participants n=23 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	0 Participants n=7 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	0 Participants n=14 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	0 Participants n=14 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	1 Participants n=130 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=27 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	0 Participants n=4 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	0 Participants n=13 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	1 Participants n=28 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	0 Participants n=23 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	0 Participants n=7 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	0 Participants n=14 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	0 Participants n=14 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	2 Participants n=130 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).
Race (NIH/OMB) Asian	2 Participants n=27 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	0 Participants n=4 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	0 Participants n=13 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	3 Participants n=28 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	1 Participants n=23 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	0 Participants n=7 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	0 Participants n=14 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	0 Participants n=14 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	6 Participants n=130 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=27 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	0 Participants n=4 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	0 Participants n=13 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	0 Participants n=28 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	0 Participants n=23 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	0 Participants n=7 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	0 Participants n=14 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	0 Participants n=14 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	0 Participants n=130 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).
Race (NIH/OMB) Black or African American	15 Participants n=27 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	1 Participants n=4 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	9 Participants n=13 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	14 Participants n=28 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	18 Participants n=23 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	7 Participants n=7 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	14 Participants n=14 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	14 Participants n=14 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	92 Participants n=130 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).
Race (NIH/OMB) White	4 Participants n=27 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	2 Participants n=4 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	1 Participants n=13 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	4 Participants n=28 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	1 Participants n=23 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	0 Participants n=7 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	0 Participants n=14 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	0 Participants n=14 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	12 Participants n=130 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).
Race (NIH/OMB) More than one race	0 Participants n=27 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	0 Participants n=4 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	0 Participants n=13 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	0 Participants n=28 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	0 Participants n=23 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	0 Participants n=7 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	0 Participants n=14 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	0 Participants n=14 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	0 Participants n=130 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=27 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	1 Participants n=4 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	3 Participants n=13 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	6 Participants n=28 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	3 Participants n=23 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	0 Participants n=7 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	0 Participants n=14 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	0 Participants n=14 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).	18 Participants n=130 Participants • Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov counts some participants multiple times (14 mothers who enrolled in both Arm 1.1 and 1.4).

PRIMARY outcome

Timeframe: Measured at 2nd trimester (2T, 20 0/7 - 26 6/7 weeks of pregnancy), 3rd trimester (3T, 30 0/7 - 37 6/7 weeks of pregnancy), and postpartum (PP, 6-12 weeks after delivery). Sampling performed pre-dose and at 1, 2, 4, 6, 8, 12, and 24 hours post-dose.

Population: Arm 1.1 and 1.2 mothers with intensive pharmacokinetic (PK) results taking the drug under study at that time period (2T, 3T, or PP). Because participants could enter the study at different time periods per the study design, they are not expected to have results at every time period.

Outcome measures

Outcome measures
Measure	Component 1: Arm 1.1: Bictegravir (BIC) 50 mg q.d. n=27 Participants Women ≥ 20 weeks gestation not receiving TB drugs and receiving bictegravir (BIC) 50 mg once daily (q.d.), and their infants	Component 1: Arm 1.2: Doravirine (DOR) 100 mg q.d. n=4 Participants Women ≥ 20 weeks gestation not receiving TB drugs and receiving doravirine (DOR) 100 mg q.d., and their infants	Component 1: Arm 1.3: Tenofovir Alafenamide (TAF) 10 mg q.d. Boosted With Cobicistat Women ≥ 20 weeks gestation not receiving TB drugs and receiving tenofovir alafenamide (TAF) 10 mg q.d. boosted with cobicistat, and their infants	Component 1: Arm 1.4: TAF 25 mg q.d. Without Boosting Women ≥ 20 weeks gestation not receiving TB drugs and receiving TAF 25 mg q.d. without boosting, and their infants	Component 3: Arm 3.1: First-line TB Treatment Drugs and Dolutegravir (DTG) Women ≥ 20 weeks gestation receiving first-line TB treatment with at least two of the following TB treatment drugs: isoniazid (INH), rifampin (RIF), rifabutin (RFB), ethambutol (EMB), pyrazinamide (PZA), moxifloxacin (MFX), and receiving dolutegravir (DTG) 50 mg twice daily (b.i.d.) when combined with RIF or 50 mg q.d. if RIF is not part of the TB regimen, and their infants	Component 4: Arm 4.1: Second-line TB Treatment Drugs Women ≥ 20 weeks gestation receiving at least one of the following second-line TB treatment drugs, and their infants: * Levofloxacin (LFX) 750mg - 1000mg q.d. * Clofazimine (CFZ) 100mg q.d. * Linezolid (LZD) 300mg - 600mg q.d. * Bedaquiline (BDQ) 200mg three times per week (t.i.w.) * Delamanid (DLM) 100mg b.i.d. * Moxifloxacin (MFX) 400mg or 800mg q.d., and at least one other second-line TB treatment drug under study	Component 5: Arm 5.1: ATV/r While Breastfeeding Women post-delivery receiving ATV/r, and their infants
Number of Women Who Meet Area Under the Curve (AUC) Target in Plasma (Component 1) 2nd Trimester	5 Participants	2 Participants	—	—	—	—	—
Number of Women Who Meet Area Under the Curve (AUC) Target in Plasma (Component 1) 3rd Trimester	11 Participants	4 Participants	—	—	—	—	—
Number of Women Who Meet Area Under the Curve (AUC) Target in Plasma (Component 1) Postpartum	21 Participants	3 Participants	—	—	—	—	—

PRIMARY outcome

Pharmacokinetic parameters were determined by the study pharmacologists from plasma concentration-time profiles using noncompartmental methods. Wilcoxon signed-rank test was not conducted for Arm 1.2 due to low sample size.

Outcome measures

Outcome measures
Measure	Component 1: Arm 1.1: Bictegravir (BIC) 50 mg q.d. n=27 Participants Women ≥ 20 weeks gestation not receiving TB drugs and receiving bictegravir (BIC) 50 mg once daily (q.d.), and their infants	Component 1: Arm 1.2: Doravirine (DOR) 100 mg q.d. n=4 Participants Women ≥ 20 weeks gestation not receiving TB drugs and receiving doravirine (DOR) 100 mg q.d., and their infants	Component 1: Arm 1.3: Tenofovir Alafenamide (TAF) 10 mg q.d. Boosted With Cobicistat Women ≥ 20 weeks gestation not receiving TB drugs and receiving tenofovir alafenamide (TAF) 10 mg q.d. boosted with cobicistat, and their infants	Component 1: Arm 1.4: TAF 25 mg q.d. Without Boosting Women ≥ 20 weeks gestation not receiving TB drugs and receiving TAF 25 mg q.d. without boosting, and their infants	Component 3: Arm 3.1: First-line TB Treatment Drugs and Dolutegravir (DTG) Women ≥ 20 weeks gestation receiving first-line TB treatment with at least two of the following TB treatment drugs: isoniazid (INH), rifampin (RIF), rifabutin (RFB), ethambutol (EMB), pyrazinamide (PZA), moxifloxacin (MFX), and receiving dolutegravir (DTG) 50 mg twice daily (b.i.d.) when combined with RIF or 50 mg q.d. if RIF is not part of the TB regimen, and their infants	Component 4: Arm 4.1: Second-line TB Treatment Drugs Women ≥ 20 weeks gestation receiving at least one of the following second-line TB treatment drugs, and their infants: * Levofloxacin (LFX) 750mg - 1000mg q.d. * Clofazimine (CFZ) 100mg q.d. * Linezolid (LZD) 300mg - 600mg q.d. * Bedaquiline (BDQ) 200mg three times per week (t.i.w.) * Delamanid (DLM) 100mg b.i.d. * Moxifloxacin (MFX) 400mg or 800mg q.d., and at least one other second-line TB treatment drug under study	Component 5: Arm 5.1: ATV/r While Breastfeeding Women post-delivery receiving ATV/r, and their infants
Median Maternal AUC in Plasma (Component 1) Postpartum	118 h*ug/mL Interval 70.2 to 132.0	52.02 h*ug/mL Interval 27.75 to 62.38	—	—	—	—	—
Median Maternal AUC in Plasma (Component 1) 2nd Trimester	53.4 h*ug/mL Interval 48.3 to 71.9	14.78 h*ug/mL Interval 0.12 to 50.18	—	—	—	—	—
Median Maternal AUC in Plasma (Component 1) 3rd Trimester	51.8 h*ug/mL Interval 38.8 to 64.6	23.71 h*ug/mL Interval 14.14 to 54.73	—	—	—	—	—

PRIMARY outcome

Population: Arm 1.3 and Arm 1.4 mothers with sparse pharmacokinetic (PK) results taking the dose under study at that time period (2T, 3T, or PP). Because participants could enter the study at different time periods per the study design, they are not expected to have results at every time period. Arm 1.5 did not enroll any participants and is therefore excluded.

TFV-DP intracellular concentrations in DBS samples. Concentrations obtained from two 7 mm punches.

Outcome measures

Outcome measures
Measure	Component 1: Arm 1.1: Bictegravir (BIC) 50 mg q.d. n=13 Participants Women ≥ 20 weeks gestation not receiving TB drugs and receiving bictegravir (BIC) 50 mg once daily (q.d.), and their infants	Component 1: Arm 1.2: Doravirine (DOR) 100 mg q.d. n=28 Participants Women ≥ 20 weeks gestation not receiving TB drugs and receiving doravirine (DOR) 100 mg q.d., and their infants	Component 1: Arm 1.3: Tenofovir Alafenamide (TAF) 10 mg q.d. Boosted With Cobicistat Women ≥ 20 weeks gestation not receiving TB drugs and receiving tenofovir alafenamide (TAF) 10 mg q.d. boosted with cobicistat, and their infants	Component 1: Arm 1.4: TAF 25 mg q.d. Without Boosting Women ≥ 20 weeks gestation not receiving TB drugs and receiving TAF 25 mg q.d. without boosting, and their infants	Component 3: Arm 3.1: First-line TB Treatment Drugs and Dolutegravir (DTG) Women ≥ 20 weeks gestation receiving first-line TB treatment with at least two of the following TB treatment drugs: isoniazid (INH), rifampin (RIF), rifabutin (RFB), ethambutol (EMB), pyrazinamide (PZA), moxifloxacin (MFX), and receiving dolutegravir (DTG) 50 mg twice daily (b.i.d.) when combined with RIF or 50 mg q.d. if RIF is not part of the TB regimen, and their infants	Component 4: Arm 4.1: Second-line TB Treatment Drugs Women ≥ 20 weeks gestation receiving at least one of the following second-line TB treatment drugs, and their infants: * Levofloxacin (LFX) 750mg - 1000mg q.d. * Clofazimine (CFZ) 100mg q.d. * Linezolid (LZD) 300mg - 600mg q.d. * Bedaquiline (BDQ) 200mg three times per week (t.i.w.) * Delamanid (DLM) 100mg b.i.d. * Moxifloxacin (MFX) 400mg or 800mg q.d., and at least one other second-line TB treatment drug under study	Component 5: Arm 5.1: ATV/r While Breastfeeding Women post-delivery receiving ATV/r, and their infants
Median Maternal Tenofovir-diphosphate (TFV-DP) Concentrations in Dried Blood Spots (DBS) (Component 1) Postpartum	609 fmol/punches Interval 412.0 to 896.0	1311 fmol/punches Interval 767.0 to 2127.0	—	—	—	—	—
Median Maternal Tenofovir-diphosphate (TFV-DP) Concentrations in Dried Blood Spots (DBS) (Component 1) 2nd Trimester	840 fmol/punches Interval 182.0 to 1035.0	596 fmol/punches Interval 541.0 to 945.0	—	—	—	—	—
Median Maternal Tenofovir-diphosphate (TFV-DP) Concentrations in Dried Blood Spots (DBS) (Component 1) 3rd Trimester	793 fmol/punches Interval 465.0 to 1035.0	867 fmol/punches Interval 548.0 to 1122.0	—	—	—	—	—

PRIMARY outcome

Timeframe: Measured at 2nd trimester (2T, 20 0/7 - 26 6/7 weeks of pregnancy), 3rd trimester (3T, 30 0/7 - 37 6/7 weeks of pregnancy), and postpartum (PP, 6-12 weeks after delivery). Samples collected pre-dose and at 3 and 24 hours post-dose.

TFV-DP intracellular concentrations in PBMC samples.

Outcome measures

Outcome measures
Measure	Component 1: Arm 1.1: Bictegravir (BIC) 50 mg q.d. n=13 Participants Women ≥ 20 weeks gestation not receiving TB drugs and receiving bictegravir (BIC) 50 mg once daily (q.d.), and their infants	Component 1: Arm 1.2: Doravirine (DOR) 100 mg q.d. n=28 Participants Women ≥ 20 weeks gestation not receiving TB drugs and receiving doravirine (DOR) 100 mg q.d., and their infants	Component 1: Arm 1.3: Tenofovir Alafenamide (TAF) 10 mg q.d. Boosted With Cobicistat Women ≥ 20 weeks gestation not receiving TB drugs and receiving tenofovir alafenamide (TAF) 10 mg q.d. boosted with cobicistat, and their infants	Component 1: Arm 1.4: TAF 25 mg q.d. Without Boosting Women ≥ 20 weeks gestation not receiving TB drugs and receiving TAF 25 mg q.d. without boosting, and their infants	Component 3: Arm 3.1: First-line TB Treatment Drugs and Dolutegravir (DTG) Women ≥ 20 weeks gestation receiving first-line TB treatment with at least two of the following TB treatment drugs: isoniazid (INH), rifampin (RIF), rifabutin (RFB), ethambutol (EMB), pyrazinamide (PZA), moxifloxacin (MFX), and receiving dolutegravir (DTG) 50 mg twice daily (b.i.d.) when combined with RIF or 50 mg q.d. if RIF is not part of the TB regimen, and their infants	Component 4: Arm 4.1: Second-line TB Treatment Drugs Women ≥ 20 weeks gestation receiving at least one of the following second-line TB treatment drugs, and their infants: * Levofloxacin (LFX) 750mg - 1000mg q.d. * Clofazimine (CFZ) 100mg q.d. * Linezolid (LZD) 300mg - 600mg q.d. * Bedaquiline (BDQ) 200mg three times per week (t.i.w.) * Delamanid (DLM) 100mg b.i.d. * Moxifloxacin (MFX) 400mg or 800mg q.d., and at least one other second-line TB treatment drug under study	Component 5: Arm 5.1: ATV/r While Breastfeeding Women post-delivery receiving ATV/r, and their infants
Median Maternal Tenofovir-diphosphate (TFV-DP) Concentrations in Peripheral Blood Mononuclear Cells (PBMCs ) (Component 1) 2nd Trimester pre-dose	563 fmol/10^6 cells Interval 110.0 to 823.0	352 fmol/10^6 cells Interval 235.0 to 423.0	—	—	—	—	—
Median Maternal Tenofovir-diphosphate (TFV-DP) Concentrations in Peripheral Blood Mononuclear Cells (PBMCs ) (Component 1) 2nd Trimester 3 hours post-dose	1025 fmol/10^6 cells Interval 433.0 to 1175.0	523 fmol/10^6 cells Interval 379.0 to 610.0	—	—	—	—	—
Median Maternal Tenofovir-diphosphate (TFV-DP) Concentrations in Peripheral Blood Mononuclear Cells (PBMCs ) (Component 1) Postpartum Average	452 fmol/10^6 cells Interval 310.0 to 552.0	464 fmol/10^6 cells Interval 272.0 to 652.0	—	—	—	—	—
Median Maternal Tenofovir-diphosphate (TFV-DP) Concentrations in Peripheral Blood Mononuclear Cells (PBMCs ) (Component 1) 2nd Trimester 24 hours post-dose	596 fmol/10^6 cells Interval 321.0 to 864.0	467 fmol/10^6 cells Interval 256.0 to 713.0	—	—	—	—	—
Median Maternal Tenofovir-diphosphate (TFV-DP) Concentrations in Peripheral Blood Mononuclear Cells (PBMCs ) (Component 1) 2nd Trimester Average	761 fmol/10^6 cells Interval 377.0 to 882.0	408 fmol/10^6 cells Interval 349.0 to 554.0	—	—	—	—	—
Median Maternal Tenofovir-diphosphate (TFV-DP) Concentrations in Peripheral Blood Mononuclear Cells (PBMCs ) (Component 1) 3rd Trimester pre-dose	522 fmol/10^6 cells Interval 414.0 to 792.0	395 fmol/10^6 cells Interval 274.0 to 620.0	—	—	—	—	—
Median Maternal Tenofovir-diphosphate (TFV-DP) Concentrations in Peripheral Blood Mononuclear Cells (PBMCs ) (Component 1) 3rd Trimester 3 hours post-dose	654 fmol/10^6 cells Interval 376.0 to 804.0	528 fmol/10^6 cells Interval 339.0 to 716.0	—	—	—	—	—
Median Maternal Tenofovir-diphosphate (TFV-DP) Concentrations in Peripheral Blood Mononuclear Cells (PBMCs ) (Component 1) 3rd Trimester 24 hours post-dose	537 fmol/10^6 cells Interval 367.0 to 750.0	409 fmol/10^6 cells Interval 255.0 to 460.0	—	—	—	—	—
Median Maternal Tenofovir-diphosphate (TFV-DP) Concentrations in Peripheral Blood Mononuclear Cells (PBMCs ) (Component 1) 3rd Trimester Average	556 fmol/10^6 cells Interval 393.0 to 777.0	435 fmol/10^6 cells Interval 324.0 to 598.0	—	—	—	—	—
Median Maternal Tenofovir-diphosphate (TFV-DP) Concentrations in Peripheral Blood Mononuclear Cells (PBMCs ) (Component 1) Postpartum pre-dose	391 fmol/10^6 cells Interval 279.0 to 468.0	387 fmol/10^6 cells Interval 216.0 to 649.0	—	—	—	—	—
Median Maternal Tenofovir-diphosphate (TFV-DP) Concentrations in Peripheral Blood Mononuclear Cells (PBMCs ) (Component 1) Postpartum 3 hours post-dose	515 fmol/10^6 cells Interval 403.0 to 624.0	486 fmol/10^6 cells Interval 291.0 to 752.0	—	—	—	—	—
Median Maternal Tenofovir-diphosphate (TFV-DP) Concentrations in Peripheral Blood Mononuclear Cells (PBMCs ) (Component 1) Postpartum 24 hours post-dose	527 fmol/10^6 cells Interval 304.0 to 604.0	403 fmol/10^6 cells Interval 277.0 to 561.0	—	—	—	—	—

PRIMARY outcome

Timeframe: Measured at 2nd trimester (2T, 20 0/7 - 26 6/7 weeks of pregnancy), 3rd trimester (3T, 30 0/7 - 37 6/7 weeks of pregnancy), and postpartum (PP, 2-8 weeks after delivery). Sampling performed pre-dose and at 1, 2, 4, 6, 8, and 12 hours post-dose.

Population: Arm 3.1 mothers with intensive pharmacokinetic (PK) results taking INH at that time period (2T, 3T, or PP). Because participants could enter the study at different time periods per the study design, they are not expected to have results at every time period. Arms 3.2 and 3.3 did not enroll any participants and are therefore excluded.

Outcome measures

Outcome measures
Measure	Component 1: Arm 1.1: Bictegravir (BIC) 50 mg q.d. n=23 Participants Women ≥ 20 weeks gestation not receiving TB drugs and receiving bictegravir (BIC) 50 mg once daily (q.d.), and their infants	Component 1: Arm 1.2: Doravirine (DOR) 100 mg q.d. Women ≥ 20 weeks gestation not receiving TB drugs and receiving doravirine (DOR) 100 mg q.d., and their infants	Component 1: Arm 1.3: Tenofovir Alafenamide (TAF) 10 mg q.d. Boosted With Cobicistat Women ≥ 20 weeks gestation not receiving TB drugs and receiving tenofovir alafenamide (TAF) 10 mg q.d. boosted with cobicistat, and their infants	Component 1: Arm 1.4: TAF 25 mg q.d. Without Boosting Women ≥ 20 weeks gestation not receiving TB drugs and receiving TAF 25 mg q.d. without boosting, and their infants	Component 3: Arm 3.1: First-line TB Treatment Drugs and Dolutegravir (DTG) Women ≥ 20 weeks gestation receiving first-line TB treatment with at least two of the following TB treatment drugs: isoniazid (INH), rifampin (RIF), rifabutin (RFB), ethambutol (EMB), pyrazinamide (PZA), moxifloxacin (MFX), and receiving dolutegravir (DTG) 50 mg twice daily (b.i.d.) when combined with RIF or 50 mg q.d. if RIF is not part of the TB regimen, and their infants	Component 4: Arm 4.1: Second-line TB Treatment Drugs Women ≥ 20 weeks gestation receiving at least one of the following second-line TB treatment drugs, and their infants: * Levofloxacin (LFX) 750mg - 1000mg q.d. * Clofazimine (CFZ) 100mg q.d. * Linezolid (LZD) 300mg - 600mg q.d. * Bedaquiline (BDQ) 200mg three times per week (t.i.w.) * Delamanid (DLM) 100mg b.i.d. * Moxifloxacin (MFX) 400mg or 800mg q.d., and at least one other second-line TB treatment drug under study	Component 5: Arm 5.1: ATV/r While Breastfeeding Women post-delivery receiving ATV/r, and their infants
Median Maternal Isoniazid (INH) AUC in Plasma (Component 3) 2nd Trimester	10.7 h*ug/mL Interval 2.14 to 16.2	—	—	—	—	—	—
Median Maternal Isoniazid (INH) AUC in Plasma (Component 3) 3rd Trimester	11.6 h*ug/mL Interval 4.32 to 17.3	—	—	—	—	—	—
Median Maternal Isoniazid (INH) AUC in Plasma (Component 3) Postpartum	12.0 h*ug/mL Interval 7.66 to 16.2	—	—	—	—	—	—

PRIMARY outcome

Population: Arm 3.1 mothers with intensive pharmacokinetic (PK) results taking RIF at that time period (2T, 3T, or PP). Because participants could enter the study at different time periods per the study design, they are not expected to have results at every time period. Arms 3.2 and 3.3 did not enroll any participants and are therefore excluded.

Outcome measures

Outcome measures
Measure	Component 1: Arm 1.1: Bictegravir (BIC) 50 mg q.d. n=23 Participants Women ≥ 20 weeks gestation not receiving TB drugs and receiving bictegravir (BIC) 50 mg once daily (q.d.), and their infants	Component 1: Arm 1.2: Doravirine (DOR) 100 mg q.d. Women ≥ 20 weeks gestation not receiving TB drugs and receiving doravirine (DOR) 100 mg q.d., and their infants	Component 1: Arm 1.3: Tenofovir Alafenamide (TAF) 10 mg q.d. Boosted With Cobicistat Women ≥ 20 weeks gestation not receiving TB drugs and receiving tenofovir alafenamide (TAF) 10 mg q.d. boosted with cobicistat, and their infants	Component 1: Arm 1.4: TAF 25 mg q.d. Without Boosting Women ≥ 20 weeks gestation not receiving TB drugs and receiving TAF 25 mg q.d. without boosting, and their infants	Component 3: Arm 3.1: First-line TB Treatment Drugs and Dolutegravir (DTG) Women ≥ 20 weeks gestation receiving first-line TB treatment with at least two of the following TB treatment drugs: isoniazid (INH), rifampin (RIF), rifabutin (RFB), ethambutol (EMB), pyrazinamide (PZA), moxifloxacin (MFX), and receiving dolutegravir (DTG) 50 mg twice daily (b.i.d.) when combined with RIF or 50 mg q.d. if RIF is not part of the TB regimen, and their infants	Component 4: Arm 4.1: Second-line TB Treatment Drugs Women ≥ 20 weeks gestation receiving at least one of the following second-line TB treatment drugs, and their infants: * Levofloxacin (LFX) 750mg - 1000mg q.d. * Clofazimine (CFZ) 100mg q.d. * Linezolid (LZD) 300mg - 600mg q.d. * Bedaquiline (BDQ) 200mg three times per week (t.i.w.) * Delamanid (DLM) 100mg b.i.d. * Moxifloxacin (MFX) 400mg or 800mg q.d., and at least one other second-line TB treatment drug under study	Component 5: Arm 5.1: ATV/r While Breastfeeding Women post-delivery receiving ATV/r, and their infants
Median Maternal Rifampin (RIF) AUC in Plasma (Component 3) Postpartum	25.6 h*ug/mL Interval 14.8 to 29.6	—	—	—	—	—	—
Median Maternal Rifampin (RIF) AUC in Plasma (Component 3) 2nd Trimester	23.4 h*ug/mL Interval 20.0 to 38.1	—	—	—	—	—	—
Median Maternal Rifampin (RIF) AUC in Plasma (Component 3) 3rd Trimester	31.3 h*ug/mL Interval 21.6 to 44.7	—	—	—	—	—	—

PRIMARY outcome

Population: Arm 3.1 mothers with intensive pharmacokinetic (PK) results taking EMB at that time period (2T, 3T, or PP). Because participants could enter the study at different time periods per the study design, they are not expected to have results at every time period. Arms 3.2 and 3.3 did not enroll any participants and are therefore excluded.

Outcome measures

Outcome measures
Measure	Component 1: Arm 1.1: Bictegravir (BIC) 50 mg q.d. n=15 Participants Women ≥ 20 weeks gestation not receiving TB drugs and receiving bictegravir (BIC) 50 mg once daily (q.d.), and their infants	Component 1: Arm 1.2: Doravirine (DOR) 100 mg q.d. Women ≥ 20 weeks gestation not receiving TB drugs and receiving doravirine (DOR) 100 mg q.d., and their infants	Component 1: Arm 1.3: Tenofovir Alafenamide (TAF) 10 mg q.d. Boosted With Cobicistat Women ≥ 20 weeks gestation not receiving TB drugs and receiving tenofovir alafenamide (TAF) 10 mg q.d. boosted with cobicistat, and their infants	Component 1: Arm 1.4: TAF 25 mg q.d. Without Boosting Women ≥ 20 weeks gestation not receiving TB drugs and receiving TAF 25 mg q.d. without boosting, and their infants	Component 3: Arm 3.1: First-line TB Treatment Drugs and Dolutegravir (DTG) Women ≥ 20 weeks gestation receiving first-line TB treatment with at least two of the following TB treatment drugs: isoniazid (INH), rifampin (RIF), rifabutin (RFB), ethambutol (EMB), pyrazinamide (PZA), moxifloxacin (MFX), and receiving dolutegravir (DTG) 50 mg twice daily (b.i.d.) when combined with RIF or 50 mg q.d. if RIF is not part of the TB regimen, and their infants	Component 4: Arm 4.1: Second-line TB Treatment Drugs Women ≥ 20 weeks gestation receiving at least one of the following second-line TB treatment drugs, and their infants: * Levofloxacin (LFX) 750mg - 1000mg q.d. * Clofazimine (CFZ) 100mg q.d. * Linezolid (LZD) 300mg - 600mg q.d. * Bedaquiline (BDQ) 200mg three times per week (t.i.w.) * Delamanid (DLM) 100mg b.i.d. * Moxifloxacin (MFX) 400mg or 800mg q.d., and at least one other second-line TB treatment drug under study	Component 5: Arm 5.1: ATV/r While Breastfeeding Women post-delivery receiving ATV/r, and their infants
Median Maternal Ethambutol (EMB) AUC in Plasma (Component 3) 2nd Trimester	11.9 h*ug/mL Interval 7.1 to 13.5	—	—	—	—	—	—
Median Maternal Ethambutol (EMB) AUC in Plasma (Component 3) 3rd Trimester	14.8 h*ug/mL Interval 9.01 to 19.7	—	—	—	—	—	—
Median Maternal Ethambutol (EMB) AUC in Plasma (Component 3) Postpartum	19.2 h*ug/mL Interval 13.7 to 22.0	—	—	—	—	—	—

PRIMARY outcome

Population: Arm 3.1 mothers with intensive pharmacokinetic (PK) results taking PZA at that time period (2T, 3T, or PP). Because participants could enter the study at different time periods per the study design, they are not expected to have results at every time period. Arms 3.2 and 3.3 did not enroll any participants and are therefore excluded.

Pharmacokinetic parameters were determined by the study pharmacologists from plasma concentration-time profiles using noncompartmental methods. AUC reported is the AUC to the last measurable timepoint. Comparison of Antepartum vs. Postpartum was not done due to low sample size.

Outcome measures

Outcome measures
Measure	Component 1: Arm 1.1: Bictegravir (BIC) 50 mg q.d. n=14 Participants Women ≥ 20 weeks gestation not receiving TB drugs and receiving bictegravir (BIC) 50 mg once daily (q.d.), and their infants	Component 1: Arm 1.2: Doravirine (DOR) 100 mg q.d. Women ≥ 20 weeks gestation not receiving TB drugs and receiving doravirine (DOR) 100 mg q.d., and their infants	Component 1: Arm 1.3: Tenofovir Alafenamide (TAF) 10 mg q.d. Boosted With Cobicistat Women ≥ 20 weeks gestation not receiving TB drugs and receiving tenofovir alafenamide (TAF) 10 mg q.d. boosted with cobicistat, and their infants	Component 1: Arm 1.4: TAF 25 mg q.d. Without Boosting Women ≥ 20 weeks gestation not receiving TB drugs and receiving TAF 25 mg q.d. without boosting, and their infants	Component 3: Arm 3.1: First-line TB Treatment Drugs and Dolutegravir (DTG) Women ≥ 20 weeks gestation receiving first-line TB treatment with at least two of the following TB treatment drugs: isoniazid (INH), rifampin (RIF), rifabutin (RFB), ethambutol (EMB), pyrazinamide (PZA), moxifloxacin (MFX), and receiving dolutegravir (DTG) 50 mg twice daily (b.i.d.) when combined with RIF or 50 mg q.d. if RIF is not part of the TB regimen, and their infants	Component 4: Arm 4.1: Second-line TB Treatment Drugs Women ≥ 20 weeks gestation receiving at least one of the following second-line TB treatment drugs, and their infants: * Levofloxacin (LFX) 750mg - 1000mg q.d. * Clofazimine (CFZ) 100mg q.d. * Linezolid (LZD) 300mg - 600mg q.d. * Bedaquiline (BDQ) 200mg three times per week (t.i.w.) * Delamanid (DLM) 100mg b.i.d. * Moxifloxacin (MFX) 400mg or 800mg q.d., and at least one other second-line TB treatment drug under study	Component 5: Arm 5.1: ATV/r While Breastfeeding Women post-delivery receiving ATV/r, and their infants
Median Maternal Pyrazinamide (PZA) AUC in Plasma (Component 3) 2nd Trimester	309 h*ug/mL Interval 146.0 to 355.0	—	—	—	—	—	—
Median Maternal Pyrazinamide (PZA) AUC in Plasma (Component 3) 3rd Trimester	260 h*ug/mL Interval 207.0 to 322.0	—	—	—	—	—	—
Median Maternal Pyrazinamide (PZA) AUC in Plasma (Component 3) Postpartum	244 h*ug/mL Interquartile range not entered due to small sample size- only one participant with postpartum AUC data.	—	—	—	—	—	—

PRIMARY outcome

Population: Arm 3.1 mothers with intensive pharmacokinetic (PK) results taking DTG at that time period (2T, 3T, or PP). Because participants could enter the study at different time periods per the study design, they are not expected to have results at every time period. Arms 3.2 and 3.3 did not enroll any participants and are therefore excluded.

Pharmacokinetic parameters were determined by the study pharmacologists from plasma concentration-time profiles using noncompartmental methods. AUC reported is the AUC to the last measurable timepoint. The data of the P1026s arm was not reported since it's not one of the arms in this study.

Outcome measures

Outcome measures
Measure	Component 1: Arm 1.1: Bictegravir (BIC) 50 mg q.d. n=23 Participants Women ≥ 20 weeks gestation not receiving TB drugs and receiving bictegravir (BIC) 50 mg once daily (q.d.), and their infants	Component 1: Arm 1.2: Doravirine (DOR) 100 mg q.d. Women ≥ 20 weeks gestation not receiving TB drugs and receiving doravirine (DOR) 100 mg q.d., and their infants	Component 1: Arm 1.3: Tenofovir Alafenamide (TAF) 10 mg q.d. Boosted With Cobicistat Women ≥ 20 weeks gestation not receiving TB drugs and receiving tenofovir alafenamide (TAF) 10 mg q.d. boosted with cobicistat, and their infants	Component 1: Arm 1.4: TAF 25 mg q.d. Without Boosting Women ≥ 20 weeks gestation not receiving TB drugs and receiving TAF 25 mg q.d. without boosting, and their infants	Component 3: Arm 3.1: First-line TB Treatment Drugs and Dolutegravir (DTG) Women ≥ 20 weeks gestation receiving first-line TB treatment with at least two of the following TB treatment drugs: isoniazid (INH), rifampin (RIF), rifabutin (RFB), ethambutol (EMB), pyrazinamide (PZA), moxifloxacin (MFX), and receiving dolutegravir (DTG) 50 mg twice daily (b.i.d.) when combined with RIF or 50 mg q.d. if RIF is not part of the TB regimen, and their infants	Component 4: Arm 4.1: Second-line TB Treatment Drugs Women ≥ 20 weeks gestation receiving at least one of the following second-line TB treatment drugs, and their infants: * Levofloxacin (LFX) 750mg - 1000mg q.d. * Clofazimine (CFZ) 100mg q.d. * Linezolid (LZD) 300mg - 600mg q.d. * Bedaquiline (BDQ) 200mg three times per week (t.i.w.) * Delamanid (DLM) 100mg b.i.d. * Moxifloxacin (MFX) 400mg or 800mg q.d., and at least one other second-line TB treatment drug under study	Component 5: Arm 5.1: ATV/r While Breastfeeding Women post-delivery receiving ATV/r, and their infants
Median Maternal Dolutegravir (DTG) AUC in Plasma (Component 3) 2nd Trimester	27.2 h*ug/mL Interval 23.4 to 34.9	—	—	—	—	—	—
Median Maternal Dolutegravir (DTG) AUC in Plasma (Component 3) 3rd Trimester	16.3 h*ug/mL Interval 12.9 to 26.8	—	—	—	—	—	—
Median Maternal Dolutegravir (DTG) AUC in Plasma (Component 3) Postpartum	23.3 h*ug/mL Interval 17.1 to 28.6	—	—	—	—	—	—

PRIMARY outcome

Population: Arm 4.1 mothers with intensive pharmacokinetic (PK) results taking BDQ at that time period (2T, 3T, or PP). Because participants could enter the study at different time periods per the study design, they are not expected to have results at every time period.

Pharmacokinetic parameters were determined by the study pharmacologists from plasma concentration-time profiles using noncompartmental methods. AUC reported is the AUC to the last measurable timepoint. Wilcoxon signed-rank test was not conducted for Arm 4.1 due to low sample size.

Outcome measures

Outcome measures
Measure	Component 1: Arm 1.1: Bictegravir (BIC) 50 mg q.d. n=5 Participants Women ≥ 20 weeks gestation not receiving TB drugs and receiving bictegravir (BIC) 50 mg once daily (q.d.), and their infants	Component 1: Arm 1.2: Doravirine (DOR) 100 mg q.d. Women ≥ 20 weeks gestation not receiving TB drugs and receiving doravirine (DOR) 100 mg q.d., and their infants	Component 1: Arm 1.3: Tenofovir Alafenamide (TAF) 10 mg q.d. Boosted With Cobicistat Women ≥ 20 weeks gestation not receiving TB drugs and receiving tenofovir alafenamide (TAF) 10 mg q.d. boosted with cobicistat, and their infants	Component 1: Arm 1.4: TAF 25 mg q.d. Without Boosting Women ≥ 20 weeks gestation not receiving TB drugs and receiving TAF 25 mg q.d. without boosting, and their infants	Component 3: Arm 3.1: First-line TB Treatment Drugs and Dolutegravir (DTG) Women ≥ 20 weeks gestation receiving first-line TB treatment with at least two of the following TB treatment drugs: isoniazid (INH), rifampin (RIF), rifabutin (RFB), ethambutol (EMB), pyrazinamide (PZA), moxifloxacin (MFX), and receiving dolutegravir (DTG) 50 mg twice daily (b.i.d.) when combined with RIF or 50 mg q.d. if RIF is not part of the TB regimen, and their infants	Component 4: Arm 4.1: Second-line TB Treatment Drugs Women ≥ 20 weeks gestation receiving at least one of the following second-line TB treatment drugs, and their infants: * Levofloxacin (LFX) 750mg - 1000mg q.d. * Clofazimine (CFZ) 100mg q.d. * Linezolid (LZD) 300mg - 600mg q.d. * Bedaquiline (BDQ) 200mg three times per week (t.i.w.) * Delamanid (DLM) 100mg b.i.d. * Moxifloxacin (MFX) 400mg or 800mg q.d., and at least one other second-line TB treatment drug under study	Component 5: Arm 5.1: ATV/r While Breastfeeding Women post-delivery receiving ATV/r, and their infants
Median Maternal Bedqauiline (BDQ) AUC in Plasma (Component 4) 2nd Trimester	15.3 h*ug/mL Interval 4.05 to 15.6	—	—	—	—	—	—
Median Maternal Bedqauiline (BDQ) AUC in Plasma (Component 4) 3rd Trimester	16.1 h*ug/mL Interval 10.2 to 18.0	—	—	—	—	—	—
Median Maternal Bedqauiline (BDQ) AUC in Plasma (Component 4) Postpartum	NA h*ug/mL Measure was not analyzed since result was available for only one participant	—	—	—	—	—	—

PRIMARY outcome

Population: Arm 4.1 mothers with intensive pharmacokinetic (PK) results taking CFZ at that time period (2T, 3T, or PP). Because participants could enter the study at different time periods per the study design, they are not expected to have results at every time period.

Pharmacokinetic parameters were determined by the study pharmacologists from plasma concentration-time profiles using noncompartmental methods. AUC reported is the AUC to the last measurable timepoint. Wilcoxon signed-rank test was not conducted for Arm 4.1 due to low sample size.

Outcome measures

Outcome measures
Measure	Component 1: Arm 1.1: Bictegravir (BIC) 50 mg q.d. n=4 Participants Women ≥ 20 weeks gestation not receiving TB drugs and receiving bictegravir (BIC) 50 mg once daily (q.d.), and their infants	Component 1: Arm 1.2: Doravirine (DOR) 100 mg q.d. Women ≥ 20 weeks gestation not receiving TB drugs and receiving doravirine (DOR) 100 mg q.d., and their infants	Component 1: Arm 1.3: Tenofovir Alafenamide (TAF) 10 mg q.d. Boosted With Cobicistat Women ≥ 20 weeks gestation not receiving TB drugs and receiving tenofovir alafenamide (TAF) 10 mg q.d. boosted with cobicistat, and their infants	Component 1: Arm 1.4: TAF 25 mg q.d. Without Boosting Women ≥ 20 weeks gestation not receiving TB drugs and receiving TAF 25 mg q.d. without boosting, and their infants	Component 3: Arm 3.1: First-line TB Treatment Drugs and Dolutegravir (DTG) Women ≥ 20 weeks gestation receiving first-line TB treatment with at least two of the following TB treatment drugs: isoniazid (INH), rifampin (RIF), rifabutin (RFB), ethambutol (EMB), pyrazinamide (PZA), moxifloxacin (MFX), and receiving dolutegravir (DTG) 50 mg twice daily (b.i.d.) when combined with RIF or 50 mg q.d. if RIF is not part of the TB regimen, and their infants	Component 4: Arm 4.1: Second-line TB Treatment Drugs Women ≥ 20 weeks gestation receiving at least one of the following second-line TB treatment drugs, and their infants: * Levofloxacin (LFX) 750mg - 1000mg q.d. * Clofazimine (CFZ) 100mg q.d. * Linezolid (LZD) 300mg - 600mg q.d. * Bedaquiline (BDQ) 200mg three times per week (t.i.w.) * Delamanid (DLM) 100mg b.i.d. * Moxifloxacin (MFX) 400mg or 800mg q.d., and at least one other second-line TB treatment drug under study	Component 5: Arm 5.1: ATV/r While Breastfeeding Women post-delivery receiving ATV/r, and their infants
Median Maternal Clofazimine (CFZ) AUC in Plasma (Component 4) 2nd Trimester	NA h*ug/mL Measure was not analyzed since result was available for only one participant	—	—	—	—	—	—
Median Maternal Clofazimine (CFZ) AUC in Plasma (Component 4) 3rd Trimester	2.17 h*ug/mL Interval 1.7 to 6.65	—	—	—	—	—	—
Median Maternal Clofazimine (CFZ) AUC in Plasma (Component 4) Postpartum	2.64 h*ug/mL Interval 0.275 to 5.53	—	—	—	—	—	—

PRIMARY outcome

Population: Arm 4.1 mothers with intensive pharmacokinetic (PK) results taking DLM at that time period (2T, 3T, or PP). Because participants could enter the study at different time periods per the study design, they are not expected to have results at every time period.

Pharmacokinetic parameters were determined by the study pharmacologists from plasma concentration-time profiles using noncompartmental methods. AUC reported is the AUC to the last measurable timepoint. Wilcoxon signed-rank test was not conducted for Arm 4.1 due to low sample size.

Outcome measures

Outcome measures
Measure	Component 1: Arm 1.1: Bictegravir (BIC) 50 mg q.d. n=5 Participants Women ≥ 20 weeks gestation not receiving TB drugs and receiving bictegravir (BIC) 50 mg once daily (q.d.), and their infants	Component 1: Arm 1.2: Doravirine (DOR) 100 mg q.d. Women ≥ 20 weeks gestation not receiving TB drugs and receiving doravirine (DOR) 100 mg q.d., and their infants	Component 1: Arm 1.3: Tenofovir Alafenamide (TAF) 10 mg q.d. Boosted With Cobicistat Women ≥ 20 weeks gestation not receiving TB drugs and receiving tenofovir alafenamide (TAF) 10 mg q.d. boosted with cobicistat, and their infants	Component 1: Arm 1.4: TAF 25 mg q.d. Without Boosting Women ≥ 20 weeks gestation not receiving TB drugs and receiving TAF 25 mg q.d. without boosting, and their infants	Component 3: Arm 3.1: First-line TB Treatment Drugs and Dolutegravir (DTG) Women ≥ 20 weeks gestation receiving first-line TB treatment with at least two of the following TB treatment drugs: isoniazid (INH), rifampin (RIF), rifabutin (RFB), ethambutol (EMB), pyrazinamide (PZA), moxifloxacin (MFX), and receiving dolutegravir (DTG) 50 mg twice daily (b.i.d.) when combined with RIF or 50 mg q.d. if RIF is not part of the TB regimen, and their infants	Component 4: Arm 4.1: Second-line TB Treatment Drugs Women ≥ 20 weeks gestation receiving at least one of the following second-line TB treatment drugs, and their infants: * Levofloxacin (LFX) 750mg - 1000mg q.d. * Clofazimine (CFZ) 100mg q.d. * Linezolid (LZD) 300mg - 600mg q.d. * Bedaquiline (BDQ) 200mg three times per week (t.i.w.) * Delamanid (DLM) 100mg b.i.d. * Moxifloxacin (MFX) 400mg or 800mg q.d., and at least one other second-line TB treatment drug under study	Component 5: Arm 5.1: ATV/r While Breastfeeding Women post-delivery receiving ATV/r, and their infants
Median Maternal Delamanid (DLM) AUC in Plasma (Component 4) 2nd Trimester	3.95 h*ug/mL Interval 0.228 to 3.96	—	—	—	—	—	—
Median Maternal Delamanid (DLM) AUC in Plasma (Component 4) 3rd Trimester	1.88 h*ug/mL Interval 0.898 to 4.17	—	—	—	—	—	—
Median Maternal Delamanid (DLM) AUC in Plasma (Component 4) Postpartum	2.45 h*ug/mL Interval 0.928 to 3.06	—	—	—	—	—	—

PRIMARY outcome

Population: Arm 4.1 mothers with intensive pharmacokinetic (PK) results taking LFX at that time period (2T, 3T, or PP). Because participants could enter the study at different time periods per the study design, they are not expected to have results at every time period.

Outcome measures

Outcome measures
Measure	Component 1: Arm 1.1: Bictegravir (BIC) 50 mg q.d. n=7 Participants Women ≥ 20 weeks gestation not receiving TB drugs and receiving bictegravir (BIC) 50 mg once daily (q.d.), and their infants	Component 1: Arm 1.2: Doravirine (DOR) 100 mg q.d. Women ≥ 20 weeks gestation not receiving TB drugs and receiving doravirine (DOR) 100 mg q.d., and their infants	Component 1: Arm 1.3: Tenofovir Alafenamide (TAF) 10 mg q.d. Boosted With Cobicistat Women ≥ 20 weeks gestation not receiving TB drugs and receiving tenofovir alafenamide (TAF) 10 mg q.d. boosted with cobicistat, and their infants	Component 1: Arm 1.4: TAF 25 mg q.d. Without Boosting Women ≥ 20 weeks gestation not receiving TB drugs and receiving TAF 25 mg q.d. without boosting, and their infants	Component 3: Arm 3.1: First-line TB Treatment Drugs and Dolutegravir (DTG) Women ≥ 20 weeks gestation receiving first-line TB treatment with at least two of the following TB treatment drugs: isoniazid (INH), rifampin (RIF), rifabutin (RFB), ethambutol (EMB), pyrazinamide (PZA), moxifloxacin (MFX), and receiving dolutegravir (DTG) 50 mg twice daily (b.i.d.) when combined with RIF or 50 mg q.d. if RIF is not part of the TB regimen, and their infants	Component 4: Arm 4.1: Second-line TB Treatment Drugs Women ≥ 20 weeks gestation receiving at least one of the following second-line TB treatment drugs, and their infants: * Levofloxacin (LFX) 750mg - 1000mg q.d. * Clofazimine (CFZ) 100mg q.d. * Linezolid (LZD) 300mg - 600mg q.d. * Bedaquiline (BDQ) 200mg three times per week (t.i.w.) * Delamanid (DLM) 100mg b.i.d. * Moxifloxacin (MFX) 400mg or 800mg q.d., and at least one other second-line TB treatment drug under study	Component 5: Arm 5.1: ATV/r While Breastfeeding Women post-delivery receiving ATV/r, and their infants
Median Maternal Levofloxacin (LFX) AUC in Plasma (Component 4) 2nd Trimester	61.1 h*ug/mL Interval 44.9 to 64.2	—	—	—	—	—	—
Median Maternal Levofloxacin (LFX) AUC in Plasma (Component 4) 3rd Trimester	56.7 h*ug/mL Interval 46.0 to 77.4	—	—	—	—	—	—
Median Maternal Levofloxacin (LFX) AUC in Plasma (Component 4) Postpartum	62.7 h*ug/mL Interval 58.5 to 101.0	—	—	—	—	—	—

PRIMARY outcome

Population: Arm 4.1 mothers with intensive pharmacokinetic (PK) results taking LZD at that time period (2T, 3T, or PP). Because participants could enter the study at different time periods per the study design, they are not expected to have results at every time period.

Pharmacokinetic parameters were determined by the study pharmacologists from plasma concentration-time profiles using noncompartmental methods. AUC reported is the AUC to the last measurable timepoint. Wilcoxon signed-rank test was not conducted for Arm 4.1 due to low sample size.

Outcome measures

Outcome measures
Measure	Component 1: Arm 1.1: Bictegravir (BIC) 50 mg q.d. n=5 Participants Women ≥ 20 weeks gestation not receiving TB drugs and receiving bictegravir (BIC) 50 mg once daily (q.d.), and their infants	Component 1: Arm 1.2: Doravirine (DOR) 100 mg q.d. Women ≥ 20 weeks gestation not receiving TB drugs and receiving doravirine (DOR) 100 mg q.d., and their infants	Component 1: Arm 1.3: Tenofovir Alafenamide (TAF) 10 mg q.d. Boosted With Cobicistat Women ≥ 20 weeks gestation not receiving TB drugs and receiving tenofovir alafenamide (TAF) 10 mg q.d. boosted with cobicistat, and their infants	Component 1: Arm 1.4: TAF 25 mg q.d. Without Boosting Women ≥ 20 weeks gestation not receiving TB drugs and receiving TAF 25 mg q.d. without boosting, and their infants	Component 3: Arm 3.1: First-line TB Treatment Drugs and Dolutegravir (DTG) Women ≥ 20 weeks gestation receiving first-line TB treatment with at least two of the following TB treatment drugs: isoniazid (INH), rifampin (RIF), rifabutin (RFB), ethambutol (EMB), pyrazinamide (PZA), moxifloxacin (MFX), and receiving dolutegravir (DTG) 50 mg twice daily (b.i.d.) when combined with RIF or 50 mg q.d. if RIF is not part of the TB regimen, and their infants	Component 4: Arm 4.1: Second-line TB Treatment Drugs Women ≥ 20 weeks gestation receiving at least one of the following second-line TB treatment drugs, and their infants: * Levofloxacin (LFX) 750mg - 1000mg q.d. * Clofazimine (CFZ) 100mg q.d. * Linezolid (LZD) 300mg - 600mg q.d. * Bedaquiline (BDQ) 200mg three times per week (t.i.w.) * Delamanid (DLM) 100mg b.i.d. * Moxifloxacin (MFX) 400mg or 800mg q.d., and at least one other second-line TB treatment drug under study	Component 5: Arm 5.1: ATV/r While Breastfeeding Women post-delivery receiving ATV/r, and their infants
Median Maternal Linezolid (LZD) AUC in Plasma (Component 4) Postpartum	139 h*ug/mL Interval 120.0 to 157.0	—	—	—	—	—	—
Median Maternal Linezolid (LZD) AUC in Plasma (Component 4) 2nd Trimester	72.2 h*ug/mL Interval 66.0 to 105.0	—	—	—	—	—	—
Median Maternal Linezolid (LZD) AUC in Plasma (Component 4) 3rd Trimester	73.5 h*ug/mL Interval 68.1 to 116.0	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Measured at 5-9 days, 2-12 weeks, and 16-24 weeks post-delivery

Population: Arm 5.1 mothers with single and breast milk pharmacokinetic (PK) results at that time period (5-9 days, 2-12 weeks, and 16-24 weeks post-delivery).

Breast milk and maternal plasma concentrations were collected at study visits and compared as a ratio. A higher ratio indicates the potential for higher infant drug exposure through breast milk. Only measured for mothers who met the breast milk transfer PK sampling requirements outlined in the protocol.

Outcome measures

Outcome measures
Measure	Component 1: Arm 1.1: Bictegravir (BIC) 50 mg q.d. n=14 Participants Women ≥ 20 weeks gestation not receiving TB drugs and receiving bictegravir (BIC) 50 mg once daily (q.d.), and their infants	Component 1: Arm 1.2: Doravirine (DOR) 100 mg q.d. Women ≥ 20 weeks gestation not receiving TB drugs and receiving doravirine (DOR) 100 mg q.d., and their infants	Component 1: Arm 1.3: Tenofovir Alafenamide (TAF) 10 mg q.d. Boosted With Cobicistat Women ≥ 20 weeks gestation not receiving TB drugs and receiving tenofovir alafenamide (TAF) 10 mg q.d. boosted with cobicistat, and their infants	Component 1: Arm 1.4: TAF 25 mg q.d. Without Boosting Women ≥ 20 weeks gestation not receiving TB drugs and receiving TAF 25 mg q.d. without boosting, and their infants	Component 3: Arm 3.1: First-line TB Treatment Drugs and Dolutegravir (DTG) Women ≥ 20 weeks gestation receiving first-line TB treatment with at least two of the following TB treatment drugs: isoniazid (INH), rifampin (RIF), rifabutin (RFB), ethambutol (EMB), pyrazinamide (PZA), moxifloxacin (MFX), and receiving dolutegravir (DTG) 50 mg twice daily (b.i.d.) when combined with RIF or 50 mg q.d. if RIF is not part of the TB regimen, and their infants	Component 4: Arm 4.1: Second-line TB Treatment Drugs Women ≥ 20 weeks gestation receiving at least one of the following second-line TB treatment drugs, and their infants: * Levofloxacin (LFX) 750mg - 1000mg q.d. * Clofazimine (CFZ) 100mg q.d. * Linezolid (LZD) 300mg - 600mg q.d. * Bedaquiline (BDQ) 200mg three times per week (t.i.w.) * Delamanid (DLM) 100mg b.i.d. * Moxifloxacin (MFX) 400mg or 800mg q.d., and at least one other second-line TB treatment drug under study	Component 5: Arm 5.1: ATV/r While Breastfeeding Women post-delivery receiving ATV/r, and their infants
Median Maternal Atazanavir (ATV) Breast Milk/Maternal Plasma Concentration Ratio (Component 5) 2-12 Weeks Post Delivery	0.270 unitless Interval 0.225 to 0.41	—	—	—	—	—	—
Median Maternal Atazanavir (ATV) Breast Milk/Maternal Plasma Concentration Ratio (Component 5) 5-9 Days Post Delivery	0.226 unitless Interval 0.167 to 0.368	—	—	—	—	—	—
Median Maternal Atazanavir (ATV) Breast Milk/Maternal Plasma Concentration Ratio (Component 5) 16-24 Weeks Post Delivery	0.255 unitless Interval 0.218 to 0.369	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Measured at 5-9 days, 2-12 weeks, and 16-24 weeks post-delivery

Population: Arm 5.1 mothers with single and breast milk pharmacokinetic (PK) results at that time period (5-9 days, 2-12 weeks, and 16-24 weeks post-delivery). Arms 5.2 and 5.3 did not enroll any participants and are therefore excluded.

Outcome measures

Outcome measures
Measure	Component 1: Arm 1.1: Bictegravir (BIC) 50 mg q.d. n=14 Participants Women ≥ 20 weeks gestation not receiving TB drugs and receiving bictegravir (BIC) 50 mg once daily (q.d.), and their infants	Component 1: Arm 1.2: Doravirine (DOR) 100 mg q.d. Women ≥ 20 weeks gestation not receiving TB drugs and receiving doravirine (DOR) 100 mg q.d., and their infants	Component 1: Arm 1.3: Tenofovir Alafenamide (TAF) 10 mg q.d. Boosted With Cobicistat Women ≥ 20 weeks gestation not receiving TB drugs and receiving tenofovir alafenamide (TAF) 10 mg q.d. boosted with cobicistat, and their infants	Component 1: Arm 1.4: TAF 25 mg q.d. Without Boosting Women ≥ 20 weeks gestation not receiving TB drugs and receiving TAF 25 mg q.d. without boosting, and their infants	Component 3: Arm 3.1: First-line TB Treatment Drugs and Dolutegravir (DTG) Women ≥ 20 weeks gestation receiving first-line TB treatment with at least two of the following TB treatment drugs: isoniazid (INH), rifampin (RIF), rifabutin (RFB), ethambutol (EMB), pyrazinamide (PZA), moxifloxacin (MFX), and receiving dolutegravir (DTG) 50 mg twice daily (b.i.d.) when combined with RIF or 50 mg q.d. if RIF is not part of the TB regimen, and their infants	Component 4: Arm 4.1: Second-line TB Treatment Drugs Women ≥ 20 weeks gestation receiving at least one of the following second-line TB treatment drugs, and their infants: * Levofloxacin (LFX) 750mg - 1000mg q.d. * Clofazimine (CFZ) 100mg q.d. * Linezolid (LZD) 300mg - 600mg q.d. * Bedaquiline (BDQ) 200mg three times per week (t.i.w.) * Delamanid (DLM) 100mg b.i.d. * Moxifloxacin (MFX) 400mg or 800mg q.d., and at least one other second-line TB treatment drug under study	Component 5: Arm 5.1: ATV/r While Breastfeeding Women post-delivery receiving ATV/r, and their infants
Median Maternal Ritonavir (RTV) Breast Milk/Maternal Plasma Concentration Ratio (Component 5) 5-9 Days Post Delivery	0.100 unitless Interval 0.07 to 0.104	—	—	—	—	—	—
Median Maternal Ritonavir (RTV) Breast Milk/Maternal Plasma Concentration Ratio (Component 5) 2-12 Weeks Post Delivery	0.092 unitless Interval 0.063 to 0.1	—	—	—	—	—	—
Median Maternal Ritonavir (RTV) Breast Milk/Maternal Plasma Concentration Ratio (Component 5) 16-24 Weeks Post Delivery	0.061 unitless Interval 0.048 to 0.1	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Measured at 5-9 days, 2-12 weeks, and 16-24 weeks of life

Population: Arm 5.1 infants with washout pharmacokinetic (PK) results at that time period (5-9 days, 2-12 weeks, and 16-24 weeks of life). Arms 5.2 and 5.3 did not enroll any participants and are therefore excluded.

Only measured for infants who met the breast milk transfer PK sampling requirements outlined in the protocol. The lower limit of quantitation (LLoQ) was 23.4 ng/mL for ATV.

Outcome measures

Outcome measures
Measure	Component 1: Arm 1.1: Bictegravir (BIC) 50 mg q.d. n=14 Participants Women ≥ 20 weeks gestation not receiving TB drugs and receiving bictegravir (BIC) 50 mg once daily (q.d.), and their infants	Component 1: Arm 1.2: Doravirine (DOR) 100 mg q.d. Women ≥ 20 weeks gestation not receiving TB drugs and receiving doravirine (DOR) 100 mg q.d., and their infants	Component 1: Arm 1.3: Tenofovir Alafenamide (TAF) 10 mg q.d. Boosted With Cobicistat Women ≥ 20 weeks gestation not receiving TB drugs and receiving tenofovir alafenamide (TAF) 10 mg q.d. boosted with cobicistat, and their infants	Component 1: Arm 1.4: TAF 25 mg q.d. Without Boosting Women ≥ 20 weeks gestation not receiving TB drugs and receiving TAF 25 mg q.d. without boosting, and their infants	Component 3: Arm 3.1: First-line TB Treatment Drugs and Dolutegravir (DTG) Women ≥ 20 weeks gestation receiving first-line TB treatment with at least two of the following TB treatment drugs: isoniazid (INH), rifampin (RIF), rifabutin (RFB), ethambutol (EMB), pyrazinamide (PZA), moxifloxacin (MFX), and receiving dolutegravir (DTG) 50 mg twice daily (b.i.d.) when combined with RIF or 50 mg q.d. if RIF is not part of the TB regimen, and their infants	Component 4: Arm 4.1: Second-line TB Treatment Drugs Women ≥ 20 weeks gestation receiving at least one of the following second-line TB treatment drugs, and their infants: * Levofloxacin (LFX) 750mg - 1000mg q.d. * Clofazimine (CFZ) 100mg q.d. * Linezolid (LZD) 300mg - 600mg q.d. * Bedaquiline (BDQ) 200mg three times per week (t.i.w.) * Delamanid (DLM) 100mg b.i.d. * Moxifloxacin (MFX) 400mg or 800mg q.d., and at least one other second-line TB treatment drug under study	Component 5: Arm 5.1: ATV/r While Breastfeeding Women post-delivery receiving ATV/r, and their infants
Infant Atazanvir (ATV) Plasma Concentration (Component 5) 5-9 Days of Life/Entry · <LLoQ	14 Participants	—	—	—	—	—	—
Infant Atazanvir (ATV) Plasma Concentration (Component 5) 5-9 Days of Life/Entry · >=LLoQ	0 Participants	—	—	—	—	—	—
Infant Atazanvir (ATV) Plasma Concentration (Component 5) 2-12 Weeks of Life · <LLoQ	14 Participants	—	—	—	—	—	—
Infant Atazanvir (ATV) Plasma Concentration (Component 5) 2-12 Weeks of Life · >=LLoQ	0 Participants	—	—	—	—	—	—
Infant Atazanvir (ATV) Plasma Concentration (Component 5) 16-24 Weeks of Life · <LLoQ	14 Participants	—	—	—	—	—	—
Infant Atazanvir (ATV) Plasma Concentration (Component 5) 16-24 Weeks of Life · >=LLoQ	0 Participants	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Measured at 5-9 days, 2-12 weeks, and 16-24 weeks of life

Only measured for infants who met the breast milk transfer PK sampling requirements outlined in the protocol. The lower limit of quantitation (LLoQ) was 9.8 ng/mL for RTV.

Outcome measures

Outcome measures
Measure	Component 1: Arm 1.1: Bictegravir (BIC) 50 mg q.d. n=14 Participants Women ≥ 20 weeks gestation not receiving TB drugs and receiving bictegravir (BIC) 50 mg once daily (q.d.), and their infants	Component 1: Arm 1.2: Doravirine (DOR) 100 mg q.d. Women ≥ 20 weeks gestation not receiving TB drugs and receiving doravirine (DOR) 100 mg q.d., and their infants	Component 1: Arm 1.3: Tenofovir Alafenamide (TAF) 10 mg q.d. Boosted With Cobicistat Women ≥ 20 weeks gestation not receiving TB drugs and receiving tenofovir alafenamide (TAF) 10 mg q.d. boosted with cobicistat, and their infants	Component 1: Arm 1.4: TAF 25 mg q.d. Without Boosting Women ≥ 20 weeks gestation not receiving TB drugs and receiving TAF 25 mg q.d. without boosting, and their infants	Component 3: Arm 3.1: First-line TB Treatment Drugs and Dolutegravir (DTG) Women ≥ 20 weeks gestation receiving first-line TB treatment with at least two of the following TB treatment drugs: isoniazid (INH), rifampin (RIF), rifabutin (RFB), ethambutol (EMB), pyrazinamide (PZA), moxifloxacin (MFX), and receiving dolutegravir (DTG) 50 mg twice daily (b.i.d.) when combined with RIF or 50 mg q.d. if RIF is not part of the TB regimen, and their infants	Component 4: Arm 4.1: Second-line TB Treatment Drugs Women ≥ 20 weeks gestation receiving at least one of the following second-line TB treatment drugs, and their infants: * Levofloxacin (LFX) 750mg - 1000mg q.d. * Clofazimine (CFZ) 100mg q.d. * Linezolid (LZD) 300mg - 600mg q.d. * Bedaquiline (BDQ) 200mg three times per week (t.i.w.) * Delamanid (DLM) 100mg b.i.d. * Moxifloxacin (MFX) 400mg or 800mg q.d., and at least one other second-line TB treatment drug under study	Component 5: Arm 5.1: ATV/r While Breastfeeding Women post-delivery receiving ATV/r, and their infants
Infant Ritonavir (RTV) Plasma Concentration (Component 5) 5-9 Days of Life/Entry · <LLoQ	14 Participants	—	—	—	—	—	—
Infant Ritonavir (RTV) Plasma Concentration (Component 5) 5-9 Days of Life/Entry · >=LLoQ	0 Participants	—	—	—	—	—	—
Infant Ritonavir (RTV) Plasma Concentration (Component 5) 2-12 Weeks of Life · <LLoQ	14 Participants	—	—	—	—	—	—
Infant Ritonavir (RTV) Plasma Concentration (Component 5) 2-12 Weeks of Life · >=LLoQ	0 Participants	—	—	—	—	—	—
Infant Ritonavir (RTV) Plasma Concentration (Component 5) 16-24 Weeks of Life · <LLoQ	14 Participants	—	—	—	—	—	—
Infant Ritonavir (RTV) Plasma Concentration (Component 5) 16-24 Weeks of Life · >=LLoQ	0 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Measured at time of delivery with single cord blood and single maternal blood sample.

Population: Arm 1.1 and 1.2 participants with cord blood drawn immediately after the cord was clamped and maternal blood samples drawn at the time the cord was clamped at delivery. If both cord blood and maternal blood concentrations were below the lower limit of quantification, the ratio was excluded from the analyses.

Cord blood and maternal blood concentrations were collected and measured for the drug(s) under study at delivery and compared as a ratio.

Outcome measures

Outcome measures
Measure	Component 1: Arm 1.1: Bictegravir (BIC) 50 mg q.d. n=17 Participants Women ≥ 20 weeks gestation not receiving TB drugs and receiving bictegravir (BIC) 50 mg once daily (q.d.), and their infants	Component 1: Arm 1.2: Doravirine (DOR) 100 mg q.d. n=4 Participants Women ≥ 20 weeks gestation not receiving TB drugs and receiving doravirine (DOR) 100 mg q.d., and their infants	Component 1: Arm 1.3: Tenofovir Alafenamide (TAF) 10 mg q.d. Boosted With Cobicistat Women ≥ 20 weeks gestation not receiving TB drugs and receiving tenofovir alafenamide (TAF) 10 mg q.d. boosted with cobicistat, and their infants	Component 1: Arm 1.4: TAF 25 mg q.d. Without Boosting Women ≥ 20 weeks gestation not receiving TB drugs and receiving TAF 25 mg q.d. without boosting, and their infants	Component 3: Arm 3.1: First-line TB Treatment Drugs and Dolutegravir (DTG) Women ≥ 20 weeks gestation receiving first-line TB treatment with at least two of the following TB treatment drugs: isoniazid (INH), rifampin (RIF), rifabutin (RFB), ethambutol (EMB), pyrazinamide (PZA), moxifloxacin (MFX), and receiving dolutegravir (DTG) 50 mg twice daily (b.i.d.) when combined with RIF or 50 mg q.d. if RIF is not part of the TB regimen, and their infants	Component 4: Arm 4.1: Second-line TB Treatment Drugs Women ≥ 20 weeks gestation receiving at least one of the following second-line TB treatment drugs, and their infants: * Levofloxacin (LFX) 750mg - 1000mg q.d. * Clofazimine (CFZ) 100mg q.d. * Linezolid (LZD) 300mg - 600mg q.d. * Bedaquiline (BDQ) 200mg three times per week (t.i.w.) * Delamanid (DLM) 100mg b.i.d. * Moxifloxacin (MFX) 400mg or 800mg q.d., and at least one other second-line TB treatment drug under study	Component 5: Arm 5.1: ATV/r While Breastfeeding Women post-delivery receiving ATV/r, and their infants
Median Ratio of Cord Blood Concentration to Maternal Blood Concentration (Component 1, Arms 1.1 and 1.2)	1.42 unitless Interval 1.21 to 1.73	0.53 unitless Interval 0.42 to 0.77	—	—	—	—	—

SECONDARY outcome

Timeframe: Measured at time of delivery with single cord blood and single maternal blood sample.

Population: Arm 1.3 and 1.4 participants with cord blood drawn immediately after the cord was clamped and maternal blood samples drawn at the time the cord was clamped at delivery. If both cord blood and maternal blood concentrations were below the lower limit of quantification, the ratio was excluded from the analyses. Arm 1.5 did not enroll any participants and is therefore excluded.

Cord blood and maternal blood concentrations were collected and measured for the drug(s) under study at delivery and compared as a ratio. There are four analytes for Arms 1.3 and 1.4: tenofovir alafenamide fumarate (TAF) in plasma, tenofovir-diphosphate (TFV-DP) in dried blood spots (DBS), TFV-DP in peripheral blood mononuclear cells (PBMCs), and tenofovir (TFV) in plasma. For Arm 1.3 TAF in plasma, all values were below the lower level of quantitation.

Outcome measures

Outcome measures
Measure	Component 1: Arm 1.1: Bictegravir (BIC) 50 mg q.d. n=9 Participants Women ≥ 20 weeks gestation not receiving TB drugs and receiving bictegravir (BIC) 50 mg once daily (q.d.), and their infants	Component 1: Arm 1.2: Doravirine (DOR) 100 mg q.d. n=17 Participants Women ≥ 20 weeks gestation not receiving TB drugs and receiving doravirine (DOR) 100 mg q.d., and their infants	Component 1: Arm 1.3: Tenofovir Alafenamide (TAF) 10 mg q.d. Boosted With Cobicistat Women ≥ 20 weeks gestation not receiving TB drugs and receiving tenofovir alafenamide (TAF) 10 mg q.d. boosted with cobicistat, and their infants	Component 1: Arm 1.4: TAF 25 mg q.d. Without Boosting Women ≥ 20 weeks gestation not receiving TB drugs and receiving TAF 25 mg q.d. without boosting, and their infants	Component 3: Arm 3.1: First-line TB Treatment Drugs and Dolutegravir (DTG) Women ≥ 20 weeks gestation receiving first-line TB treatment with at least two of the following TB treatment drugs: isoniazid (INH), rifampin (RIF), rifabutin (RFB), ethambutol (EMB), pyrazinamide (PZA), moxifloxacin (MFX), and receiving dolutegravir (DTG) 50 mg twice daily (b.i.d.) when combined with RIF or 50 mg q.d. if RIF is not part of the TB regimen, and their infants	Component 4: Arm 4.1: Second-line TB Treatment Drugs Women ≥ 20 weeks gestation receiving at least one of the following second-line TB treatment drugs, and their infants: * Levofloxacin (LFX) 750mg - 1000mg q.d. * Clofazimine (CFZ) 100mg q.d. * Linezolid (LZD) 300mg - 600mg q.d. * Bedaquiline (BDQ) 200mg three times per week (t.i.w.) * Delamanid (DLM) 100mg b.i.d. * Moxifloxacin (MFX) 400mg or 800mg q.d., and at least one other second-line TB treatment drug under study	Component 5: Arm 5.1: ATV/r While Breastfeeding Women post-delivery receiving ATV/r, and their infants
Median Ratio of Cord Blood Concentration to Maternal Blood Concentration (Component 1, Arms 1.3 and 1.4) TFV-DP in PBMCs	0.08 unitless Interval 0.04 to 0.1	0.05 unitless Interval 0.03 to 0.07	—	—	—	—	—
Median Ratio of Cord Blood Concentration to Maternal Blood Concentration (Component 1, Arms 1.3 and 1.4) Tenofovir in plasma	0.70 unitless Interval 0.64 to 0.92	0.77 unitless Interval 0.69 to 0.85	—	—	—	—	—
Median Ratio of Cord Blood Concentration to Maternal Blood Concentration (Component 1, Arms 1.3 and 1.4) TAF in plasma	—	0.18 unitless Interval 0.01 to 0.34	—	—	—	—	—
Median Ratio of Cord Blood Concentration to Maternal Blood Concentration (Component 1, Arms 1.3 and 1.4) TFV-DP in DBS	0.34 unitless Interval 0.2 to 0.38	0.27 unitless Interval 0.24 to 0.41	—	—	—	—	—

SECONDARY outcome

Timeframe: Measured at time of delivery with single cord blood and single maternal blood sample.

Population: Component 3 participants taking the drugs under study with cord blood drawn immediately after the cord was clamped and maternal blood samples drawn at the time the cord was clamped at delivery. If both cord blood and maternal blood concentrations were below the lower limit of quantification, the ratio was excluded from the analyses.

Cord blood and maternal blood concentrations were collected and measured for the drugs under study at delivery and compared as a ratio. The analytes for Arm 3.1 were: isoniazid (INH), rifampin (RIF), ethambutol (EMB), pyrazinamide (PZA), and dolutegravir (DTG).

Outcome measures

Outcome measures
Measure	Component 1: Arm 1.1: Bictegravir (BIC) 50 mg q.d. n=6 Participants Women ≥ 20 weeks gestation not receiving TB drugs and receiving bictegravir (BIC) 50 mg once daily (q.d.), and their infants	Component 1: Arm 1.2: Doravirine (DOR) 100 mg q.d. Women ≥ 20 weeks gestation not receiving TB drugs and receiving doravirine (DOR) 100 mg q.d., and their infants	Component 1: Arm 1.3: Tenofovir Alafenamide (TAF) 10 mg q.d. Boosted With Cobicistat Women ≥ 20 weeks gestation not receiving TB drugs and receiving tenofovir alafenamide (TAF) 10 mg q.d. boosted with cobicistat, and their infants	Component 1: Arm 1.4: TAF 25 mg q.d. Without Boosting Women ≥ 20 weeks gestation not receiving TB drugs and receiving TAF 25 mg q.d. without boosting, and their infants	Component 3: Arm 3.1: First-line TB Treatment Drugs and Dolutegravir (DTG) Women ≥ 20 weeks gestation receiving first-line TB treatment with at least two of the following TB treatment drugs: isoniazid (INH), rifampin (RIF), rifabutin (RFB), ethambutol (EMB), pyrazinamide (PZA), moxifloxacin (MFX), and receiving dolutegravir (DTG) 50 mg twice daily (b.i.d.) when combined with RIF or 50 mg q.d. if RIF is not part of the TB regimen, and their infants	Component 4: Arm 4.1: Second-line TB Treatment Drugs Women ≥ 20 weeks gestation receiving at least one of the following second-line TB treatment drugs, and their infants: * Levofloxacin (LFX) 750mg - 1000mg q.d. * Clofazimine (CFZ) 100mg q.d. * Linezolid (LZD) 300mg - 600mg q.d. * Bedaquiline (BDQ) 200mg three times per week (t.i.w.) * Delamanid (DLM) 100mg b.i.d. * Moxifloxacin (MFX) 400mg or 800mg q.d., and at least one other second-line TB treatment drug under study	Component 5: Arm 5.1: ATV/r While Breastfeeding Women post-delivery receiving ATV/r, and their infants
Median Ratio of Cord Blood Concentration to Maternal Blood Concentration (Component 3) INH	1.26 unitless Interval 0.918 to 1.61	—	—	—	—	—	—
Median Ratio of Cord Blood Concentration to Maternal Blood Concentration (Component 3) RIF	0.437 unitless Interval 0.375 to 0.498	—	—	—	—	—	—
Median Ratio of Cord Blood Concentration to Maternal Blood Concentration (Component 3) EMB	NA unitless Measure was not analyzed since result was available for only one participant	—	—	—	—	—	—
Median Ratio of Cord Blood Concentration to Maternal Blood Concentration (Component 3) DTG	2.22 unitless Interval 0.592 to 3.71	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Measured at time of delivery with single cord blood and single maternal blood sample.

Population: Component 4 participants taking the drugs under study with cord blood drawn immediately after the cord was clamped and maternal blood samples drawn at the time the cord was clamped at delivery. Ratios could not be calculated for Arm 4.1 for any drug as only a single delivery maternal blood concentration was obtained and no cord blood concentrations were collected.

Cord blood and maternal blood concentrations were collected and measured for the drugs under study at delivery and compared as a ratio. The analytes for Arm 4.1 were: bedaquiline (BDQ), clofazimine (CFZ), delamanid (DLM), levofloxacin (LFX), and linezolid (LZD).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Measured at birth (2-10 hours, 18-28 hours and 36-72 hours) and 5-9 days after birth

Population: Component 1 infants who meet the requirements for infant washout PK sampling, are not breastfeeding, and for whom washout half life (T1/2) could be estimated. For Arm 1.3 with 0 overall participants analyzed, none of the participants had washout T1/2 data available due to the number of concentrations near or below the LLoQ.

Infant washout PK concentrations were measured during the first 9 days of life. Half-life was calculated based on the concentrations. The analyte of Arm 1.4 is tenofovir in plasma.

Outcome measures

Outcome measures
Measure	Component 1: Arm 1.1: Bictegravir (BIC) 50 mg q.d. n=25 Participants Women ≥ 20 weeks gestation not receiving TB drugs and receiving bictegravir (BIC) 50 mg once daily (q.d.), and their infants	Component 1: Arm 1.2: Doravirine (DOR) 100 mg q.d. n=3 Participants Women ≥ 20 weeks gestation not receiving TB drugs and receiving doravirine (DOR) 100 mg q.d., and their infants	Component 1: Arm 1.3: Tenofovir Alafenamide (TAF) 10 mg q.d. Boosted With Cobicistat n=13 Participants Women ≥ 20 weeks gestation not receiving TB drugs and receiving tenofovir alafenamide (TAF) 10 mg q.d. boosted with cobicistat, and their infants	Component 1: Arm 1.4: TAF 25 mg q.d. Without Boosting n=5 Participants Women ≥ 20 weeks gestation not receiving TB drugs and receiving TAF 25 mg q.d. without boosting, and their infants	Component 3: Arm 3.1: First-line TB Treatment Drugs and Dolutegravir (DTG) Women ≥ 20 weeks gestation receiving first-line TB treatment with at least two of the following TB treatment drugs: isoniazid (INH), rifampin (RIF), rifabutin (RFB), ethambutol (EMB), pyrazinamide (PZA), moxifloxacin (MFX), and receiving dolutegravir (DTG) 50 mg twice daily (b.i.d.) when combined with RIF or 50 mg q.d. if RIF is not part of the TB regimen, and their infants	Component 4: Arm 4.1: Second-line TB Treatment Drugs Women ≥ 20 weeks gestation receiving at least one of the following second-line TB treatment drugs, and their infants: * Levofloxacin (LFX) 750mg - 1000mg q.d. * Clofazimine (CFZ) 100mg q.d. * Linezolid (LZD) 300mg - 600mg q.d. * Bedaquiline (BDQ) 200mg three times per week (t.i.w.) * Delamanid (DLM) 100mg b.i.d. * Moxifloxacin (MFX) 400mg or 800mg q.d., and at least one other second-line TB treatment drug under study	Component 5: Arm 5.1: ATV/r While Breastfeeding Women post-delivery receiving ATV/r, and their infants
Median Infant Washout Half-life of Drug After Birth (Component 1)	33.2 hours Interval 25.7 to 45.9	32.20 hours Interval 27.59 to 35.27	NA hours T1/2 could not be calculated for any of the participants because profiles were below the limit of quantitation per the study pharmacologist.	30.0 hours Interval 22.2 to 30.1	—	—	—

SECONDARY outcome

Timeframe: Measured at birth (2-10 hours, 18-28 hours and 36-72 hours) and 5-9 days after birth

Population: Arm 3.1 infants who meet the requirements for infant washout PK sampling, are not breastfeeding, and for whom washout half life (T1/2) could be estimated. Arms 3.2 and 3.3 did not enroll any participants and are therefore excluded. For Arm 3.1, T1/2 could not be calculated for any of the participants because profiles were either below the limit of quantitation or quantifiable results were too sporadic for reliable calculations per the study pharmacologist.

Infant washout PK concentrations were measured during the first 9 days of life. Half-life was calculated based on the concentrations. The analytes for Arm 3.1 were: isoniazid (INH), rifampin (RIF), ethambutol (EMB), pyrazinamide (PZA), and dolutegravir (DTG).

Outcome measures

Outcome measures
Measure	Component 1: Arm 1.1: Bictegravir (BIC) 50 mg q.d. n=23 Participants Women ≥ 20 weeks gestation not receiving TB drugs and receiving bictegravir (BIC) 50 mg once daily (q.d.), and their infants	Component 1: Arm 1.2: Doravirine (DOR) 100 mg q.d. Women ≥ 20 weeks gestation not receiving TB drugs and receiving doravirine (DOR) 100 mg q.d., and their infants	Component 1: Arm 1.3: Tenofovir Alafenamide (TAF) 10 mg q.d. Boosted With Cobicistat Women ≥ 20 weeks gestation not receiving TB drugs and receiving tenofovir alafenamide (TAF) 10 mg q.d. boosted with cobicistat, and their infants	Component 1: Arm 1.4: TAF 25 mg q.d. Without Boosting Women ≥ 20 weeks gestation not receiving TB drugs and receiving TAF 25 mg q.d. without boosting, and their infants	Component 3: Arm 3.1: First-line TB Treatment Drugs and Dolutegravir (DTG) Women ≥ 20 weeks gestation receiving first-line TB treatment with at least two of the following TB treatment drugs: isoniazid (INH), rifampin (RIF), rifabutin (RFB), ethambutol (EMB), pyrazinamide (PZA), moxifloxacin (MFX), and receiving dolutegravir (DTG) 50 mg twice daily (b.i.d.) when combined with RIF or 50 mg q.d. if RIF is not part of the TB regimen, and their infants	Component 4: Arm 4.1: Second-line TB Treatment Drugs Women ≥ 20 weeks gestation receiving at least one of the following second-line TB treatment drugs, and their infants: * Levofloxacin (LFX) 750mg - 1000mg q.d. * Clofazimine (CFZ) 100mg q.d. * Linezolid (LZD) 300mg - 600mg q.d. * Bedaquiline (BDQ) 200mg three times per week (t.i.w.) * Delamanid (DLM) 100mg b.i.d. * Moxifloxacin (MFX) 400mg or 800mg q.d., and at least one other second-line TB treatment drug under study	Component 5: Arm 5.1: ATV/r While Breastfeeding Women post-delivery receiving ATV/r, and their infants
Infant Washout Half-life of Drug After Birth (Component 3)	NA hours T1/2 could not be calculated for any of the participants because profiles were either below the limit of quantitation or quantifiable results were too sporadic for reliable calculations per the study pharmacologist.	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Measured at birth (2-10 hours, 18-28 hours and 36-72 hours) and 5-9 days after birth

Population: Arm 4.1 infants who meet the requirements for infant washout PK sampling, are not breastfeeding, and for whom washout half life (T1/2) could be estimated. For Arm 4.1, T1/2 could not be calculated for any of the participants because profiles were either below the limit of quantitation or quantifiable results were too sporadic for reliable calculations per the study pharmacologist.

Infant washout PK concentrations were measured during the first 9 days of life. Half-life was calculated based on the concentrations where it was possible to calculate. The analytes for Arm 4.1 were: bedaquiline (BDQ), clofazimine (CFZ), delamanid (DLM), levofloxacin (LFX), and linezolid (LZD).

Outcome measures

Outcome measures
Measure	Component 1: Arm 1.1: Bictegravir (BIC) 50 mg q.d. n=7 Participants Women ≥ 20 weeks gestation not receiving TB drugs and receiving bictegravir (BIC) 50 mg once daily (q.d.), and their infants	Component 1: Arm 1.2: Doravirine (DOR) 100 mg q.d. Women ≥ 20 weeks gestation not receiving TB drugs and receiving doravirine (DOR) 100 mg q.d., and their infants	Component 1: Arm 1.3: Tenofovir Alafenamide (TAF) 10 mg q.d. Boosted With Cobicistat Women ≥ 20 weeks gestation not receiving TB drugs and receiving tenofovir alafenamide (TAF) 10 mg q.d. boosted with cobicistat, and their infants	Component 1: Arm 1.4: TAF 25 mg q.d. Without Boosting Women ≥ 20 weeks gestation not receiving TB drugs and receiving TAF 25 mg q.d. without boosting, and their infants	Component 3: Arm 3.1: First-line TB Treatment Drugs and Dolutegravir (DTG) Women ≥ 20 weeks gestation receiving first-line TB treatment with at least two of the following TB treatment drugs: isoniazid (INH), rifampin (RIF), rifabutin (RFB), ethambutol (EMB), pyrazinamide (PZA), moxifloxacin (MFX), and receiving dolutegravir (DTG) 50 mg twice daily (b.i.d.) when combined with RIF or 50 mg q.d. if RIF is not part of the TB regimen, and their infants	Component 4: Arm 4.1: Second-line TB Treatment Drugs Women ≥ 20 weeks gestation receiving at least one of the following second-line TB treatment drugs, and their infants: * Levofloxacin (LFX) 750mg - 1000mg q.d. * Clofazimine (CFZ) 100mg q.d. * Linezolid (LZD) 300mg - 600mg q.d. * Bedaquiline (BDQ) 200mg three times per week (t.i.w.) * Delamanid (DLM) 100mg b.i.d. * Moxifloxacin (MFX) 400mg or 800mg q.d., and at least one other second-line TB treatment drug under study	Component 5: Arm 5.1: ATV/r While Breastfeeding Women post-delivery receiving ATV/r, and their infants
Infant Washout Half-life of Drug After Birth (Component 4)	NA hours T1/2 could not be calculated for any of the participants because profiles were either below the limit of quantitation or quantifiable results were too sporadic for reliable calculations per the study pharmacologist.	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Measured at 2-8 weeks postpartum (and 5-9 days and 16-24 weeks post-delivery if the requirements for breast milk transfer PK sampling are met)

Breast milk and maternal plasma concentrations were collected at study visits to be compared as a ratio, measured for mothers who met the breast milk transfer PK sampling requirements outlined in the protocol. A higher ratio indicates the potential for higher infant drug exposure through breast milk. Per the protocol, breast milk transfer sampling was not to be performed for Arm 3.1. For Arm 4.1, samples were collected but not run and have yet to be analyzed. The anticipated reporting date is April 2027.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Measured through Week 24

Population: Infants of participants with postpartum breast milk samples collected and run. Per the protocol, breast milk transfer sampling was not to be performed for Arm 3.1, so infant plasma concentrations were not measured for this arm.

Plasma concentrations as part of breast milk transfer sampling. Per the protocol, breast milk transfer sampling was not to be performed for Arm 3.1.