Trial Outcomes & Findings for The Women TDF-FTC Benchmark Study (NCT NCT05057858)

Last Updated: 2026-06-15

Results Overview

TFV-DP concentrations observed in dried blood spots (DBS) after eight weeks of directly observed therapy with TDF/FTC oral PrEP, in women randomized to receive 2, 4, or 7 doses per week, representing poor, moderate, or perfect adherence, respectively. Emtricitabine triphosphate FTC-TP measures are not reported, as FTC-TP was not quantifiable in DBS samples from 100%, 81%, and 21% percent of participants receiving 2, 4, and 7 doses per week, respectively.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

72 participants

Primary outcome timeframe

Assessed at 8 weeks

Results posted on

2026-06-15

Participant Flow

101 women (73 non-pregnant and 28 pregnant) were screened for study participation from 27 April 2022 to 17 March 2023 at the Kenya Medical Research Institute, Center for Clinical Research, Thika site in Kenya. Of these, 72 healthy volunteer women ages 18-30 comprising 54 non-pregnant women at low risk of HIV acquisition and 18 pregnant women at high risk of HIV acquisition were enrolled into the study and randomized.

Participant milestones

Participant milestones
Measure	Perfect Adherence Cisgender women will receive a single tablet of co-formulated 300 mg TDF/ 200mg FTC once daily (7 doses per week).	Moderate Adherence Cisgender women will receive a single tablet of co-formulated 300 mg TDF/ 200mg FTC tablet 4 times per week (Monday, Tuesday, Thursday, Friday)	Poor Adherence Cisgender women will receive a single tablet of co-formulated 300 mg TDF/ 200mg FTC tablet twice per week(Monday and Tuesday)	Pregnant Pregnant cisgender women will receive a single tablet of co-formulated 300 mg TDF/ 200mg FTC once daily (7 doses per week).
Directly observed therapy (DOT) Phase STARTED	18	18	18	18
Directly observed therapy (DOT) Phase COMPLETED	17	16	16	18
Directly observed therapy (DOT) Phase NOT COMPLETED	1	2	2	0
Post-DOT Phase STARTED	17	16	16	8
Post-DOT Phase COMPLETED	17	16	16	8
Post-DOT Phase NOT COMPLETED	0	0	0	0
Postpartum follow-up STARTED	0	0	0	18
Postpartum follow-up COMPLETED	0	0	0	17
Postpartum follow-up NOT COMPLETED	0	0	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Perfect Adherence Cisgender women will receive a single tablet of co-formulated 300 mg TDF/ 200mg FTC once daily (7 doses per week).	Moderate Adherence Cisgender women will receive a single tablet of co-formulated 300 mg TDF/ 200mg FTC tablet 4 times per week (Monday, Tuesday, Thursday, Friday)	Poor Adherence Cisgender women will receive a single tablet of co-formulated 300 mg TDF/ 200mg FTC tablet twice per week(Monday and Tuesday)	Pregnant Pregnant cisgender women will receive a single tablet of co-formulated 300 mg TDF/ 200mg FTC once daily (7 doses per week).
Directly observed therapy (DOT) Phase Pregnancy	1	2	0	0
Directly observed therapy (DOT) Phase Terminated due to missed study visit	0	0	1	0
Directly observed therapy (DOT) Phase Withdrawal by Subject	0	0	1	0
Postpartum follow-up Stillbirth: no postpartum followup	0	0	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Perfect Adherence n=18 Participants Cisgender women will receive a single tablet of co-formulated 300 mg TDF/ 200mg FTC once daily (7 doses per week).	Moderate Adherence n=18 Participants Cisgender women will receive a single tablet of co-formulated 300 mg TDF/ 200mg FTC tablet 4 times per week (Monday, Tuesday, Thursday, Friday)	Poor Adherence n=18 Participants Cisgender women will receive a single tablet of co-formulated 300 mg TDF/ 200mg FTC tablet twice per week(Monday and Tuesday)	Pregnant n=18 Participants Pregnant cisgender women will receive a single tablet of co-formulated 300 mg TDF/ 200mg FTC once daily (7 doses per week).	Total n=72 Participants Total of all reporting groups
Age, Customized Median age	23 years n=18 Participants	22 years n=18 Participants	22 years n=18 Participants	22.5 years n=18 Participants	22.5 years n=72 Participants
Sex: Female, Male Female	18 Participants n=18 Participants	18 Participants n=18 Participants	18 Participants n=18 Participants	18 Participants n=18 Participants	72 Participants n=72 Participants
Sex: Female, Male Male	0 Participants n=18 Participants	0 Participants n=18 Participants	0 Participants n=18 Participants	0 Participants n=18 Participants	0 Participants n=72 Participants
Race and Ethnicity Not Collected	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Kenya	18 Participants n=18 Participants	18 Participants n=18 Participants	18 Participants n=18 Participants	18 Participants n=18 Participants	72 Participants n=72 Participants

PRIMARY outcome

Timeframe: Assessed at 8 weeks

Population: Forty-nine non-pregnant participants were fully evaluable per protocol. Five non-pregnant participants did not complete the DOT period and were not fully evaluable, as described in the participant flow. These five participants contributed data up to the visit before they were censored. All 18 pregnant participants completed the DOT period. However, one pregnant participant was non-adherent to the study drug throughout the dosing period and her blood samples were excluded from analysis.

Outcome measures

Outcome measures
Measure	Poor Adherence n=16 Participants Cisgender women will receive a single tablet of co-formulated 300 mg TDF/ 200mg FTC tablet twice per week(Monday and Tuesday) co-formulated 300 mg TDF/ 200mg FTC: Participants will be randomized into 1 of 3 groups to receive a controlled number of doses of a single tablet of co-formulated 300 mg TDF/ 200mg FTC	Moderate Adherence n=16 Participants Cisgender women will receive a single tablet of co-formulated 300 mg TDF/ 200mg FTC tablet 4 times per week (Monday, Tuesday, Thursday, Friday) co-formulated 300 mg TDF/ 200mg FTC: Participants will be randomized into 1 of 3 groups to receive a controlled number of doses of a single tablet of co-formulated 300 mg TDF/ 200mg FTC	Perfect Adherence n=17 Participants Cisgender women will receive a single tablet of co-formulated 300 mg TDF/ 200mg FTC once daily (7 doses per week). co-formulated 300 mg TDF/ 200mg FTC: Participants will be randomized into 1 of 3 groups to receive a controlled number of doses of a single tablet of co-formulated 300 mg TDF/ 200mg FTC	Pregnant n=17 Participants Pregnant cisgender women will receive a single tablet of co-formulated 300 mg TDF/ 200mg FTC once daily (7 doses per week). co-formulated 300 mg TDF/ 200mg FTC: Participants will be randomized into 1 of 3 groups to receive a controlled number of doses of a single tablet of co-formulated 300 mg TDF/ 200mg FTC
Concentrations of Tenofovir Disphosphate (TFV-DP) Measured at Eight Weeks in Dried Blood Spots (DBS)	359 fmol/punch Interval 266.0 to 464.0	749 fmol/punch Interval 596.0 to 923.0	1389 fmol/punch Interval 1151.0 to 1551.0	798.9 fmol/punch Interval 767.3 to 947.1

PRIMARY outcome

Timeframe: Assessed through 8 weeks

Steady-state TFV-DP and FTC-TP concentrations observed in peripheral blood mononuclear cells (PBMCs) after eight weeks of directly observed therapy with TDF/FTC oral PrEP, in women randomized to receive 2, 4, or 7 doses per week, representing poor, moderate, or perfect adherence, respectively.

Outcome measures

Outcome measures
Measure	Poor Adherence n=16 Participants Cisgender women will receive a single tablet of co-formulated 300 mg TDF/ 200mg FTC tablet twice per week(Monday and Tuesday) co-formulated 300 mg TDF/ 200mg FTC: Participants will be randomized into 1 of 3 groups to receive a controlled number of doses of a single tablet of co-formulated 300 mg TDF/ 200mg FTC	Moderate Adherence n=16 Participants Cisgender women will receive a single tablet of co-formulated 300 mg TDF/ 200mg FTC tablet 4 times per week (Monday, Tuesday, Thursday, Friday) co-formulated 300 mg TDF/ 200mg FTC: Participants will be randomized into 1 of 3 groups to receive a controlled number of doses of a single tablet of co-formulated 300 mg TDF/ 200mg FTC	Perfect Adherence n=17 Participants Cisgender women will receive a single tablet of co-formulated 300 mg TDF/ 200mg FTC once daily (7 doses per week). co-formulated 300 mg TDF/ 200mg FTC: Participants will be randomized into 1 of 3 groups to receive a controlled number of doses of a single tablet of co-formulated 300 mg TDF/ 200mg FTC	Pregnant n=17 Participants Pregnant cisgender women will receive a single tablet of co-formulated 300 mg TDF/ 200mg FTC once daily (7 doses per week). co-formulated 300 mg TDF/ 200mg FTC: Participants will be randomized into 1 of 3 groups to receive a controlled number of doses of a single tablet of co-formulated 300 mg TDF/ 200mg FTC
Concentrations of Tenofovir Disphosphate (TFV-DP) and Emtricitabine Triphosphate (FTC-TP) Measured at Steady-state in Peripheral Blood Mononuclear Cells (PBMCs). Observed TFV-DP concentrations	7.4 fmol/10^6 cells Interval 5.6 to 14.9	31.2 fmol/10^6 cells Interval 21.5 to 39.9	59.8 fmol/10^6 cells Interval 44.7 to 74.4	49.6 fmol/10^6 cells Interval 38.3 to 60.2
Concentrations of Tenofovir Disphosphate (TFV-DP) and Emtricitabine Triphosphate (FTC-TP) Measured at Steady-state in Peripheral Blood Mononuclear Cells (PBMCs). Observed FTC-TP concentrations	483 fmol/10^6 cells Interval 325.2 to 812.6	2098.9 fmol/10^6 cells Interval 1444.1 to 3279.7	5431.3 fmol/10^6 cells Interval 3976.7 to 7002.6	5586.5 fmol/10^6 cells Interval 4012.7 to 5920.7

PRIMARY outcome

Timeframe: Assessed through 8 weeks

Population: Forty-nine non-pregnant participants were fully evaluable per protocol, while five did not complete the DOT period, as described in the participant flow. Three of these five contributed data appropriate for inclusion in estimation of steady state concentrations; two were excluded. All 18 pregnant participants completed the DOT period. However, one pregnant participant was non-adherent to the study drug throughout the dosing period and her blood samples were excluded from analysis.

Fitted steady-state TFV-DP concentrations after eight weeks of directly observed therapy with TDF/FTC oral PrEP, in women randomized to receive 2, 4, or 7 doses per week, representing poor, moderate, or perfect adherence, respectively.

Outcome measures

Outcome measures
Measure	Poor Adherence n=16 Participants Cisgender women will receive a single tablet of co-formulated 300 mg TDF/ 200mg FTC tablet twice per week(Monday and Tuesday) co-formulated 300 mg TDF/ 200mg FTC: Participants will be randomized into 1 of 3 groups to receive a controlled number of doses of a single tablet of co-formulated 300 mg TDF/ 200mg FTC	Moderate Adherence n=18 Participants Cisgender women will receive a single tablet of co-formulated 300 mg TDF/ 200mg FTC tablet 4 times per week (Monday, Tuesday, Thursday, Friday) co-formulated 300 mg TDF/ 200mg FTC: Participants will be randomized into 1 of 3 groups to receive a controlled number of doses of a single tablet of co-formulated 300 mg TDF/ 200mg FTC	Perfect Adherence n=18 Participants Cisgender women will receive a single tablet of co-formulated 300 mg TDF/ 200mg FTC once daily (7 doses per week). co-formulated 300 mg TDF/ 200mg FTC: Participants will be randomized into 1 of 3 groups to receive a controlled number of doses of a single tablet of co-formulated 300 mg TDF/ 200mg FTC	Pregnant n=17 Participants Pregnant cisgender women will receive a single tablet of co-formulated 300 mg TDF/ 200mg FTC once daily (7 doses per week). co-formulated 300 mg TDF/ 200mg FTC: Participants will be randomized into 1 of 3 groups to receive a controlled number of doses of a single tablet of co-formulated 300 mg TDF/ 200mg FTC
Fitted Steady-state TFV-DP Concentrations in Dried Blood Spots (DBS)	416 fmol/punch Interval 316.0 to 516.0	832 fmol/punch Interval 631.0 to 1033.0	1457 fmol/punch Interval 1106.0 to 1808.0	895 fmol/punch Interval 767.0 to 993.0

Adverse Events

Poor Adherence

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Moderate Adherence

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Perfect Adherence

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Pregnant

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Poor Adherence n=18 participants at risk Cisgender women will receive a single tablet of co-formulated 300 mg TDF/ 200mg FTC tablet twice per week(Monday and Tuesday) co-formulated 300 mg TDF/ 200mg FTC: Participants will be randomized into 1 of 3 groups to receive a controlled number of doses of a single tablet of co-formulated 300 mg TDF/ 200mg FTC	Moderate Adherence n=18 participants at risk Cisgender women will receive a single tablet of co-formulated 300 mg TDF/ 200mg FTC tablet 4 times per week (Monday, Tuesday, Thursday, Friday) co-formulated 300 mg TDF/ 200mg FTC: Participants will be randomized into 1 of 3 groups to receive a controlled number of doses of a single tablet of co-formulated 300 mg TDF/ 200mg FTC	Perfect Adherence n=18 participants at risk Cisgender women will receive a single tablet of co-formulated 300 mg TDF/ 200mg FTC once daily (7 doses per week). co-formulated 300 mg TDF/ 200mg FTC: Participants will be randomized into 1 of 3 groups to receive a controlled number of doses of a single tablet of co-formulated 300 mg TDF/ 200mg FTC	Pregnant n=18 participants at risk Pregnant cisgender women will receive a single tablet of co-formulated 300 mg TDF/ 200mg FTC once daily (7 doses per week). co-formulated 300 mg TDF/ 200mg FTC: Participants will be randomized into 1 of 3 groups to receive a controlled number of doses of a single tablet of co-formulated 300 mg TDF/ 200mg FTC
Gastrointestinal disorders Abdominal pain	27.8% 5/18 • Adverse event data for each participant was collected over the eight weeks between randomization (i.e., administration of the first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	5.6% 1/18 • Adverse event data for each participant was collected over the eight weeks between randomization (i.e., administration of the first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	0.00% 0/18 • Adverse event data for each participant was collected over the eight weeks between randomization (i.e., administration of the first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	22.2% 4/18 • Adverse event data for each participant was collected over the eight weeks between randomization (i.e., administration of the first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)
Gastrointestinal disorders Diarrhea	5.6% 1/18 • Adverse event data for each participant was collected over the eight weeks between randomization (i.e., administration of the first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	0.00% 0/18 • Adverse event data for each participant was collected over the eight weeks between randomization (i.e., administration of the first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	11.1% 2/18 • Adverse event data for each participant was collected over the eight weeks between randomization (i.e., administration of the first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	0.00% 0/18 • Adverse event data for each participant was collected over the eight weeks between randomization (i.e., administration of the first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)
Gastrointestinal disorders Gastritis	11.1% 2/18 • Adverse event data for each participant was collected over the eight weeks between randomization (i.e., administration of the first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	11.1% 2/18 • Adverse event data for each participant was collected over the eight weeks between randomization (i.e., administration of the first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	5.6% 1/18 • Adverse event data for each participant was collected over the eight weeks between randomization (i.e., administration of the first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	16.7% 3/18 • Adverse event data for each participant was collected over the eight weeks between randomization (i.e., administration of the first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)
Gastrointestinal disorders Nausea	16.7% 3/18 • Adverse event data for each participant was collected over the eight weeks between randomization (i.e., administration of the first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	5.6% 1/18 • Adverse event data for each participant was collected over the eight weeks between randomization (i.e., administration of the first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	27.8% 5/18 • Adverse event data for each participant was collected over the eight weeks between randomization (i.e., administration of the first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	33.3% 6/18 • Adverse event data for each participant was collected over the eight weeks between randomization (i.e., administration of the first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)
Gastrointestinal disorders Vomiting	5.6% 1/18 • Adverse event data for each participant was collected over the eight weeks between randomization (i.e., administration of the first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	0.00% 0/18 • Adverse event data for each participant was collected over the eight weeks between randomization (i.e., administration of the first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	0.00% 0/18 • Adverse event data for each participant was collected over the eight weeks between randomization (i.e., administration of the first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	44.4% 8/18 • Adverse event data for each participant was collected over the eight weeks between randomization (i.e., administration of the first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)
Gastrointestinal disorders Hyperacidity/heartburn	0.00% 0/18 • Adverse event data for each participant was collected over the eight weeks between randomization (i.e., administration of the first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	0.00% 0/18 • Adverse event data for each participant was collected over the eight weeks between randomization (i.e., administration of the first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	0.00% 0/18 • Adverse event data for each participant was collected over the eight weeks between randomization (i.e., administration of the first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	27.8% 5/18 • Adverse event data for each participant was collected over the eight weeks between randomization (i.e., administration of the first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)
Renal and urinary disorders Urinary tract infection	5.6% 1/18 • Adverse event data for each participant was collected over the eight weeks between randomization (i.e., administration of the first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	5.6% 1/18 • Adverse event data for each participant was collected over the eight weeks between randomization (i.e., administration of the first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	11.1% 2/18 • Adverse event data for each participant was collected over the eight weeks between randomization (i.e., administration of the first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	22.2% 4/18 • Adverse event data for each participant was collected over the eight weeks between randomization (i.e., administration of the first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)
Respiratory, thoracic and mediastinal disorders Upper respiratory tract infection	38.9% 7/18 • Adverse event data for each participant was collected over the eight weeks between randomization (i.e., administration of the first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	5.6% 1/18 • Adverse event data for each participant was collected over the eight weeks between randomization (i.e., administration of the first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	5.6% 1/18 • Adverse event data for each participant was collected over the eight weeks between randomization (i.e., administration of the first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	16.7% 3/18 • Adverse event data for each participant was collected over the eight weeks between randomization (i.e., administration of the first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)
Respiratory, thoracic and mediastinal disorders Pharyngitis	5.6% 1/18 • Adverse event data for each participant was collected over the eight weeks between randomization (i.e., administration of the first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	0.00% 0/18 • Adverse event data for each participant was collected over the eight weeks between randomization (i.e., administration of the first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	0.00% 0/18 • Adverse event data for each participant was collected over the eight weeks between randomization (i.e., administration of the first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	16.7% 3/18 • Adverse event data for each participant was collected over the eight weeks between randomization (i.e., administration of the first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)
Respiratory, thoracic and mediastinal disorders Rhinitis	5.6% 1/18 • Adverse event data for each participant was collected over the eight weeks between randomization (i.e., administration of the first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	5.6% 1/18 • Adverse event data for each participant was collected over the eight weeks between randomization (i.e., administration of the first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	0.00% 0/18 • Adverse event data for each participant was collected over the eight weeks between randomization (i.e., administration of the first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	11.1% 2/18 • Adverse event data for each participant was collected over the eight weeks between randomization (i.e., administration of the first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)
Nervous system disorders Headache	33.3% 6/18 • Adverse event data for each participant was collected over the eight weeks between randomization (i.e., administration of the first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	27.8% 5/18 • Adverse event data for each participant was collected over the eight weeks between randomization (i.e., administration of the first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	22.2% 4/18 • Adverse event data for each participant was collected over the eight weeks between randomization (i.e., administration of the first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	44.4% 8/18 • Adverse event data for each participant was collected over the eight weeks between randomization (i.e., administration of the first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)
General disorders Dizziness	0.00% 0/18 • Adverse event data for each participant was collected over the eight weeks between randomization (i.e., administration of the first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	0.00% 0/18 • Adverse event data for each participant was collected over the eight weeks between randomization (i.e., administration of the first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	5.6% 1/18 • Adverse event data for each participant was collected over the eight weeks between randomization (i.e., administration of the first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	11.1% 2/18 • Adverse event data for each participant was collected over the eight weeks between randomization (i.e., administration of the first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)
General disorders Fatigue	11.1% 2/18 • Adverse event data for each participant was collected over the eight weeks between randomization (i.e., administration of the first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	11.1% 2/18 • Adverse event data for each participant was collected over the eight weeks between randomization (i.e., administration of the first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	0.00% 0/18 • Adverse event data for each participant was collected over the eight weeks between randomization (i.e., administration of the first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)	11.1% 2/18 • Adverse event data for each participant was collected over the eight weeks between randomization (i.e., administration of the first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase. Adverse events meeting the following criteria were recorded: Clinical AEs of Grade 1 and above, laboratory AEs of Grade 2 and above, all AEs (clinical or laboratory) leading to a study product hold (temporary or permanent)

Additional Information

Kenneth K. Mugwanya, MBChB, MS, PhD

Departments of Global Health and Epidemiology, University of Washington

Phone: +1 206 520-3800

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place