Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and Postpartum

Summary

The purpose of this study is to evaluate the pharmacokinetic (PK) properties of antiretroviral (ARV) and anti-tuberculosis (TB) drugs administered during pregnancy and postpartum.

Conditions

• HIV Infections
• Tuberculosis

Interventions

DRUG

Bictegravir (BIC)

Administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants

DRUG

Tenofovir alafenamide (TAF)

Administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants

DRUG

Cabotegravir (CAB)

Administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants

DRUG

Dolutegravir (DTG)

Administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants

DRUG

Atazanavir/ritonavir (ATV/r)

Administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants

DRUG

Darunavir/ritonavir (DRV/r)

Administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants

DRUG

Lopinavir/ritonavir (LPV/r)

Administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants

DRUG

Cobicistat

Administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants

DRUG

Ritonavir

Administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants

DRUG

First-Line TB Treatment

Participants will be 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), or moxifloxacin (MFX). Drugs will be administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants.

DRUG

Second-Line TB Treatment

Participants will be receiving second-line TB treatment with 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 Drugs will be administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants.

DRUG

Doravirine (DOR)

Administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants

Sponsors & Collaborators

• International Maternal Pediatric Adolescent AIDS Clinical Trials Group

  collaborator NETWORK

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• National Institute of Mental Health (NIMH)

  collaborator NIH

• Gilead Sciences

  collaborator INDUSTRY

• ViiV Healthcare

  collaborator INDUSTRY

• Merck Sharp & Dohme LLC

  collaborator INDUSTRY

• National Institute of Allergy and Infectious Diseases (NIAID)

  lead NIH

Principal Investigators

• Mark Mirochnick, MD · Boston University

Eligibility

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-09-01

Primary Completion

2025-04-24

Completion

2025-07-10

FDA Drug

Yes

Countries

• United States
• Brazil
• India
• Kenya
• Puerto Rico
• South Africa
• Thailand
• Uganda

Study Locations