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

  • STATUS
    Recruiting
  • End date
    Jun 30, 2022
  • participants needed
    35
  • sponsor
    Gilead Sciences
Updated on 31 July 2021

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.

Details
Condition HIV-1-infection, HIV-1-infection, HIV-1-infection, HIV-1-infection, HIV-1-infection, HIV-1-infection, HIV-1-infection, HIV-1-infection, HIV-1-infection, HIV-1-infection, HIV-1-infection, HIV-1-infection, HIV-1-infection, HIV-1-infection, HIV-1-infection, HIV-1-infection, HIV-1-infection, HIV-1-infection, HIV-1-infection, HIV-1-infection, HIV-1-infection, HIV-1-infection, HIV-1-infection, HIV-1-infection, HIV-1-infection, HIV-1-infection, HIV-1-infection, HIV-1-infection, HIV-1-infection, HIV-1-infection, HIV-1-infection, HIV-1-infection, HIV-1-infection, HIV-1-infection, HIV-1-infection, HIV-1-infection, HIV-1-infection, HIV-1-infection, HIV-1-infection, HIV-1-infection, HIV-1-infection, HIV-1-infection, HIV-1-infection, HIV-1-infection, HIV-1-infection, HIV-1-infection, HIV-1-infection, HIV-1-infection, HIV-1-infection, HIV-1-infection, HIV-1-infection, HIV-1-infection
Treatment B/F/TAF
Clinical Study IdentifierNCT03960645
SponsorGilead Sciences
Last Modified on31 July 2021

Eligibility

Yes No Not Sure

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

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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