Last updated on July 2020

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: HIV-1-infection
  • Age: Between 18 - 40 Years
  • Gender: Female

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.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

Volunteer Sign-up

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.