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Completed

NCT Number: NCT03960645

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

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.

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Key information

Conditions

HIV-1-infection

Age range

18 year–39 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Instituto Dominicano de Estudios Virologics (IDEV), Santo Domingo, Dominican Republic

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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

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.

Treatment and study plan

B/F/TAF

Drug

50/200/25 mg FDC tablet administered orally once daily without regard to food.

Other names: GS-9883/F/TAF, Biktarvy®, BVY

Primary outcomes

  1. Pharmacokinetic (PK) Parameter: AUCtau of Bictegravir (BIC)

    Time frame: Intensive PK: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in second trimester (Weeks 20-28), third trimester (Weeks 30-38), Week 6 post-partum, and Week 12 post-partum

    AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).

Secondary outcomes

  1. PK Parameter: AUCtau of Emtricitabine (FTC) and Tenofovir Alafenamide (TAF)

    Time frame: Intensive PK: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in second trimester (Weeks 20-28), third trimester (Weeks 30-38), Week 6 post-partum, and Week 12 post-partum

    AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).

  2. PK Parameter: AUClast of BIC, FTC, and TAF

    Time frame: Intensive PK: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in second trimester (Weeks 20-28), third trimester (Weeks 30-38), Week 6 post-partum, and Week 12 post-partum

    AUClast is defined as the concentration of drug from time zero to the last observable concentration.

  3. PK Parameter: Cmax of BIC, FTC, and TAF

    Time frame: Intensive PK: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in second trimester (Weeks 20-28), third trimester (Weeks 30-38), Week 6 post-partum, and Week 12 post-partum

    Cmax is defined as the maximum observed concentration of drug during the dosing interval.

  4. PK Parameter: Ctau of BIC and FTC

    Time frame: Intensive PK: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in second trimester (Weeks 20-28), third trimester (Weeks 30-38), Week 6 post-partum, and Week 12 post-partum

    Ctau is defined as the observed drug concentration at the end of the dosing interval.

  5. PK Parameter: Clast of BIC, FTC, and TAF

    Time frame: Intensive PK: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in second trimester (Weeks 20-28), third trimester (Weeks 30-38), Week 6 post-partum, and Week 12 post-partum

    Clast is defined as the last observable concentration of drug.

  6. PK Parameter: Tmax of BIC, FTC, and TAF

    Time frame: Intensive PK: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in second trimester (Weeks 20-28), third trimester (Weeks 30-38), Week 6 post-partum, and Week 12 post-partum

    Tmax is defined as the time (observed time point) of Cmax.

  7. PK Parameter: t1/2 of BIC, FTC, and TAF

    Time frame: Intensive PK: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in second trimester (Weeks 20-28), third trimester (Weeks 30-38), Week 6 post-partum, and Week 12 post-partum

    t1/2 is defined as the estimate of the terminal elimination half-life of the drug.

  8. PK Parameter: CLss/F of BIC, FTC, and TAF

    Time frame: Intensive PK: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in second trimester (Weeks 20-28), third trimester (Weeks 30-38), Week 6 post-partum, and Week 12 post-partum

    CLss/F is defined as the apparent steady-state oral clearance following administration of the drug.

  9. PK Parameter: Vz/F of BIC, FTC, and TAF

    Time frame: Intensive PK: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in second trimester (Weeks 20-28), third trimester (Weeks 30-38), Week 6 post-partum, and Week 12 post-partum

    Vz/F is defined as the apparent volume of distribution of the drug.

  10. PK Parameter: λz of BIC, FTC, and TAF

    Time frame: Intensive PK: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in second trimester (Weeks 20-28), third trimester (Weeks 30-38), Week 6 post-partum, and Week 12 post-partum

    λz is defined as the terminal elimination rate constant, estimated by linear regression of the terminal elimination phase of the log plasma concentration of drug versus time curve of the drug.

  11. Percentage of Participants With HIV-1 RNA < 50 Copies/mL at the Time of Delivery Using the Missing = Excluded Approach in B/F/TAF Group

    Time frame: At time of delivery

    The percentage of participants with HIV-1 RNA < 50 copies/mL at the time of delivery was analyzed in B/F/TAF group using missing = excluded approach. In this approach, all missing data were excluded in the computation of the percentages (ie, missing data points were excluded from both the numerator and denominator in the computation).

  12. Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Birth Using the Missing = Excluded Approach in Neonates

    Time frame: At birth

    The percentage of participants with HIV-1 RNA < 50 copies/mL at the time of birth was analyzed in neonates using missing = excluded approach. In this approach, all missing data were excluded in the computation of the percentages (ie, missing data points were excluded from both the numerator and denominator in the computation).

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
May 23, 2019
Registry last updated
Jun 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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