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

Completed

Conditions studied: HIV Infections, Tuberculosis

In brief

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.

Key facts

Study ID

NCT04518228

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

205

Starts

2021-09-01

Expected to finish

2025-07-10

Last updated by the study team

2025-11-12

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Component 1: Pregnant WLHIV receiving oral ARVs and no TB drugs, and their infants
• Mother is of legal age or otherwise able to provide independent informed consent as determined by site standard operating procedures (SOPs) and consistent with site institutional review board (IRB)/ethics committee (EC) policies and procedures, and is willing and able to provide written informed consent for her own and her infant's participation in this study.
• Prior to study entry, HIV status confirmed as HIV infected per study protocol.
• At study entry, pregnant and in one of the following two enrollment windows based on best available obstetrical estimate of gestational age:
• Second trimester: gestational age of 20 0/7 to 26 6/7 weeks
• Third trimester: gestational age of 30 0/7 to 37 6/7 weeks
• At study entry, receiving at least one of the following oral ARV drugs or drug combinations, based on maternal report and available medical records:
• Arm 1.1: Bictegravir (BIC) 50 mg q.d.
• Arm 1.2: Doravirine (DOR) 100 mg q.d.
• Arm 1.3: Tenofovir alafenamide (TAF) - 10 mg q.d. boosted with cobicistat
• Arm 1.4: TAF 25 mg q.d. without boosting
• Arm 1.5: TAF 25 mg q.d. boosted with cobicistat or ritonavir
• At study entry, planning to continue the current ARV regimen through at least 12 weeks post-delivery, based on maternal report and available medical records.
• At study entry, has been receiving the drug or drug combination under study at the required dose for at least two weeks, based on maternal report and available medical records.
• At study entry, assessed by study staff as having no identified barriers to completing initial PK sampling within 20 0/7 - 26 6/7 weeks gestation (second trimester) or 30 0/7 to 37 6/7 weeks gestation (third trimester) and within 14 days of enrollment.
• At study entry, if receiving a generic formulation of the drug or drug combination under study, approval of the formulation per study protocol.
• At study entry, not receiving any TB drugs (for either prophylaxis or treatment), based on maternal report and available medical records.
• Component 2: Pregnant WLHIV and HIV-uninfected women who received long-acting/extended release ARVs during pregnancy, and their infants
• If of legal age or otherwise able to provide independent informed consent as determined by site SOPs and consistent with site IRB/EC policies and procedures: Willing and able to provide written informed consent for her own and her infant's participation in this study.
• If not of legal age or otherwise unable to provide independent informed consent as determined by site SOPs and consistent with site IRB/EC policies and procedures: Parent/guardian or other legally authorized representative of the mother and her infant is willing and able to provide written informed consent for the mother and her infant's study participation; in addition, when applicable, the mother is willing and able to provide written assent for her own and her infant's study participation.
• At study entry, intends to deliver at the study-affiliated clinic or hospital, based on maternal report.
• At study entry, gestational age of at least 24 0/7 weeks based on best available obstetrical estimate of gestational age, and not yet delivered.
• At study entry, has received at least one administration of the following, based on available medical records, during the current pregnancy:
• Arm 2.1: Long-acting injectable formulation of cabotegravir (CAB LA) (any dose)
• Component 3: Pregnant WLHIV receiving ARVs with first-line TB treatment, and their infants

Where it is running

• Usc La Nichd Crs — Los Angeles, California, United States
• David Geffen School of Medicine at UCLA NICHD CRS — Los Angeles, California, United States
• University of California, UC San Diego CRS- Mother-Child-Adolescent HIV Program — San Diego, California, United States
• Univ. of Colorado Denver NICHD CRS — Aurora, Colorado, United States
• South Florida CDTC Ft Lauderdale NICHD CRS — Fort Lauderdale, Florida, United States
• University of Florida Jacksonville NICHD CRS — Jacksonville, Florida, United States
• Pediatric Perinatal HIV NICHD CRS — Miami, Florida, United States
• Emory University School of Medicine NICHD CRS — Atlanta, Georgia, United States
• Rush University Cook County Hospital Chicago NICHD CRS — Chicago, Illinois, United States
• Lurie Children's Hospital of Chicago (LCH) CRS (Site ID: 4001) — Chicago, Illinois, United States
• Johns Hopkins Univ. Baltimore NICHD CRS — Baltimore, Maryland, United States
• Bronx-Lebanon Hospital Center NICHD CRS — The Bronx, New York, United States
• Jacobi Med. Ctr. Bronx NICHD CRS — The Bronx, New York, United States
• Hospital Federal dos Servidores do Estado NICHD CRS — Rio de Janeiro, Brazil
• Hosp. Geral De Nova Igaucu Brazil NICHD CRS — Rio de Janeiro, Brazil
• Byramjee Jeejeebhoy Medical College (BJMC) CRS — Pune, Maharashtra, India
• Kenya Medical Research Institute / Walter Reed Project Clinical Research Center, Kericho CRS — Kericho, Kenya
• IMPAACT/ Gamma Project/ UPR Pediatric HIV/AIDS Research CRS — San Juan, Puerto Rico
• Wits RHI Shandukani Research — Johannesburg, Gauteng, South Africa
• Desmond Tutu TB Centre - Stellenbosch University (DTTC-SU) CRS — Cape Town, South Africa
• Famcru Crs — Tygerberg Hills, South Africa
• Siriraj Hospital, Mahidol University NICHD CRS — Bangkok, Bangkoknoi, Thailand
• Baylor-Uganda CRS — Kampala, Uganda

Full record on ClinicalTrials.gov

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