Overview

Pharmacokinetic, Safety, and Efficacy of B/F/TAF in HIV-1 Infected, Virologically Suppressed, Pregnant Women in Their Second and Third Trimesters

Status:
Recruiting
Trial end date:
2023-02-01
Target enrollment:
0
Participant gender:
Female
Summary
The primary objective of this study is to evaluate the steady state pharmacokinetics 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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Gilead Sciences
Criteria
Key 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 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

- Historic genotype reports will be collected if available

- 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

Key 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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.