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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Gilead Sciences
Age
18–39
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | 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
