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Study to Evaluate the Pharmacokinetics (PK), Safety, and Efficacy of B/F/TAF in Human Immunodeficiency Virus (HIV)-1 Infected, Virologically Suppressed, Pregnant Women in Their Second and Third Trimesters | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Study to Evaluate the Pharmacokinetics (PK), Safety, and Efficacy of B/F/TAF in Human Immunodeficiency Virus (HIV)-1 Infected, Virologically Suppressed, Pregnant Women in Their Second and Third Trimesters

A Phase 1b, Open-label Study to Evaluate the PK, Safety and Efficacy of B/F/TAF in HIV-1 Infected, Virologically Suppressed, Pregnant Women in Their Second and Third Trimesters

NCT03960645•Gilead Sciences

View on ClinicalTrials.gov

Summary

The primary objective of this study is to evaluate the steady state PK of bictegravir (BIC) and confirm the dose of BIC/emtricitabine/tenofovir alafenamide (B/F/TAF) 50/200/25 mg fixed dose combination (FDC) in HIV-1 infected, virologically suppressed pregnant women in their second and third trimesters.

Eligibility

Age

18 - 39 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
•With singleton pregnancy, at least 12 weeks but not more than 31 weeks pregnant at the time of screening
•Agree not to breastfeed for the duration of the study
•Currently on a stable antiretroviral regimen for ≥ 6 months preceding the screening visit
•Documented plasma HIV-1 ribonucleic acid (RNA) levels of \< 50 copies/mL for ≥ 6 months preceding the screening visit and have HIV-1 RNA \< 50 copies/mL at the screening visit
•Have no documented or suspected resistance to FTC, Tenofovir (TFV), or integrase strand-transfer inhibitors (INSTIs) including, but not limited to, the reverse transcriptase resistance mutations K65R or M184V/I
•Have a normal ultrasound, completed locally prior to the Day 1 visit, with no evidence of any fetal malformation or structural abnormality affecting either fetus or placenta
•Normal maternal alfa-fetoprotein level at the screening visit

Exclusion Criteria

•Have chronic hepatitis B virus (HBV)
•Have active hepatitis C virus (HCV) infection
•An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening

Locations (8)

Midway Immunology and Research Center

Ft. Pierce, Florida, United States

Triple O Research Institute, P.A.

West Palm Beach, Florida, United States

Instituto Dominicano de Estudios Virologics (IDEV)

Santo Domingo, Dominican Republic

Faculty of Medicine Siriraj Hospital

Bangkok Noi, Thailand

Faculty of Medicine-Khon Kaen University

Khon Kaen, Thailand

Bamrasnaradura Infectious Diseases Institute

Nonthaburi, Thailand

Research Institute for Health Sciences, Chiang Mai University

Nonthaburi, Thailand

Thai Red Cross AIDS Research Centre

Pathumwan, Thailand

Key Dates

Start Date

June 28, 2019

Primary Completion Date

July 21, 2022

Completion Date

August 18, 2022

Last Updated

June 14, 2024

Enrollment

ACTUAL participants

Conditions

HIV-1-infection

Interventions

B/F/TAF

DRUG

Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Newborns Exposed to HIV

NCT07055451

HIV-1-infection

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RECRUITINGNA

Treatment Research Investigating Depression Effects on Neuroimmune Targets (TRIDENT)

NCT05136703

DepressionHIV-1-infection+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 14, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study to Evaluate the Pharmacokinetics (PK), Safety, and Efficacy of B/F/TAF in Human Immunodeficiency Virus (HIV)-1 Infected, Virologically Suppressed, Pregnant Women in Their Second and Third Trimesters

Inclusion Criteria

Exclusion Criteria

Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Newborns Exposed to HIV

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