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

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ClinicalTrials.gov Identifier: NCT03960645
Recruitment Status : Recruiting
First Posted : May 23, 2019
Last Update Posted : January 8, 2021
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Tracking Information
First Submitted Date  ICMJE May 21, 2019
First Posted Date  ICMJE May 23, 2019
Last Update Posted Date January 8, 2021
Actual Study Start Date  ICMJE June 28, 2019
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2019)
Pharmacokinetic (PK) Parameter: AUCtau of BIC [ Time Frame: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose ]
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2019)
  • PK Parameter: AUCtau of emtricitabine (FTC) and tenofovir alafenamide (TAF) [ Time Frame: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose ]
    AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
  • PK Parameter: AUClast of BIC, FTC, and TAF [ Time Frame: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose ]
    AUClast is defined as the concentration of drug from time zero to the last observable concentration.
  • PK Parameter: Cmax of BIC, FTC, and TAF [ Time Frame: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose ]
    Cmax is defined as the maximum observed concentration of drug during the dosing interval.
  • PK Parameter: Ctau of BIC and FTC [ Time Frame: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose ]
    Ctau is defined as the observed drug concentration at the end of the dosing interval.
  • PK Parameter: Clast of BIC, FTC, and TAF [ Time Frame: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose ]
    Clast is defined as the last observable concentration of drug.
  • PK Parameter: Tmax of BIC, FTC, and TAF [ Time Frame: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose ]
    Tmax is defined as the time (observed time point) of Cmax.
  • PK Parameter: t1/2 of BIC, FTC, and TAF [ Time Frame: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose ]
    t1/2 is defined as the estimate of the terminal elimination half-life of the drug.
  • PK Parameter: CL/F of BIC, FTC, and TAF [ Time Frame: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose ]
    CL/F is defined as the apparent oral clearance following administration of the drug.
  • PK Parameter: Vz/F of BIC, FTC, and TAF [ Time Frame: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose ]
    Vz/F is defined as the apparent volume of distribution of the drug.
  • PK Parameter: λz of BIC, FTC, and TAF [ Time Frame: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose ]
    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.
  • Proportion of Participants With HIV-1 RNA < 50 Copies/mL Using the Missing = Excluded Approach [ Time Frame: At the Time of Delivery ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetic, Safety, and Efficacy of B/F/TAF in HIV-1 Infected, Virologically Suppressed, Pregnant Women in Their Second and Third Trimesters
Official Title  ICMJE 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
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE HIV-1-infection
Intervention  ICMJE Drug: B/F/TAF
50/200/25 mg FDC tablet administered orally once daily without regard to food
Study Arms  ICMJE Experimental: B/F/TAF
B/F/TAF for up to approximately 38 weeks
Intervention: Drug: B/F/TAF
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 21, 2019)
35
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2022
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Gilead Clinical Study Information Center 1-833-445-3230 (GILEAD-0) GileadClinicalTrials@gilead.com
Listed Location Countries  ICMJE Dominican Republic,   Puerto Rico,   Thailand,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03960645
Other Study ID Numbers  ICMJE GS-US-380-5310
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Gilead Sciences
Study Sponsor  ICMJE Gilead Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Gilead Study Director Gilead Sciences
PRS Account Gilead Sciences
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP