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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
HIV-1-infection Drug: B/F/TAF Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : June 28, 2019
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Arm Intervention/treatment
Experimental: B/F/TAF
B/F/TAF for up to approximately 38 weeks
 Drug: B/F/TAF
50/200/25 mg FDC tablet administered orally once daily without regard to food


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. Proportion of Participants With HIV-1 RNA < 50 Copies/mL Using the Missing = Excluded Approach [ Time Frame: At the Time of Delivery ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03960645


Contacts
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Contact: Gilead Clinical Study Information Center 1-833-445-3230 (GILEAD-0) GileadClinicalTrials@gilead.com

Locations
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United States, California
Miller Children's & Women's Hospital Long Beach Recruiting
Long Beach, California, United States, 90806
United States, Florida
Midway Immunology and Research Center Recruiting
Fort Pierce, Florida, United States, 34982
University of South Florida Recruiting
Tampa, Florida, United States, 33762
Triple O Research Institute, P.A. Recruiting
West Palm Beach, Florida, United States, 33407
United States, North Carolina
Duke University Health System Recruiting
Durham, North Carolina, United States, 27710-0001
Dominican Republic
Instituto Dominicano de Estudios Virologics (IDEV) Active, not recruiting
Santo Domingo, Dominican Republic, 10103
Salvador B Gautier Hospital Active, not recruiting
Santo Domingo, Dominican Republic, 10514
Puerto Rico
Maternal Infant Studies Center (CEMI) Recruiting
San Juan, Puerto Rico, 00925
Thailand
Faculty of Medicine Siriraj Hospital Recruiting
Bangkok Noi, Thailand, 10700
Faculty of Medicine-Khon Kaen University Recruiting
Khon Kaen, Thailand, 40002
Bamrasnaradura Infectious Diseases Institute Recruiting
Muang, Thailand, 11000
Research Institute for Health Sciences, Chiang Mai University Recruiting
Muang, Thailand, 50200
Thai Red Cross AIDS Research Centre Recruiting
Pathumwan, Thailand, 10330
Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences
More Information
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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT03960645    
Other Study ID Numbers: GS-US-380-5310
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: January 8, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No