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
NCT ID: NCT03960645
Last Updated: 2024-06-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
62 participants
INTERVENTIONAL
2019-06-28
2022-08-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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B/F/TAF
Pregnant women participants will receive fixed dose combination (FDC) tablet of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) 50/200/25 mg for up to 38 weeks (from the second or third trimesters of pregnancy, depending on enrollment, through 12 weeks post-partum).
B/F/TAF
50/200/25 mg FDC tablet administered orally once daily without regard to food.
Neonates
Neonates who will be born to women participants in the study will be followed from birth up to 8 weeks of age after obtaining consent from the parent or legal guardian. None of the neonates that participate in the study will be treated with the study drug.
No interventions assigned to this group
Interventions
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B/F/TAF
50/200/25 mg FDC tablet administered orally once daily without regard to food.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Have active hepatitis C virus (HCV) infection
* An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening
18 Years
39 Years
FEMALE
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Midway Immunology and Research Center
Ft. Pierce, Florida, United States
Triple O Research Institute, P.A.
West Palm Beach, Florida, United States
Instituto Dominicano de Estudios Virologics (IDEV)
Santo Domingo, , Dominican Republic
Faculty of Medicine Siriraj Hospital
Bangkok Noi, , Thailand
Faculty of Medicine-Khon Kaen University
Khon Kaen, , Thailand
Bamrasnaradura Infectious Diseases Institute
Nonthaburi, , Thailand
Research Institute for Health Sciences, Chiang Mai University
Nonthaburi, , Thailand
Thai Red Cross AIDS Research Centre
Pathumwan, , Thailand
Countries
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References
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Zhang H, Hindman JT, Lin L, Davis M, Shang J, Xiao D, Avihingsanon A, Arora P, Palaparthy R, Girish S, Marathe DD. A study of the pharmacokinetics, safety, and efficacy of bictegravir/emtricitabine/tenofovir alafenamide in virologically suppressed pregnant women with HIV. AIDS. 2024 Jan 1;38(1):F1-F9. doi: 10.1097/QAD.0000000000003783. Epub 2023 Nov 22.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2021-001073-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-380-5310
Identifier Type: -
Identifier Source: org_study_id
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