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

Phase 1 Completed 62 enrolled Gilead Sciences

Non-randomizedSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start: 2019-06-28
Primary completion: 2022-07-21
Completion: 2022-08-18

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	bictegravir	Small molecule	50 mg	Oral
Subject	emtricitabine	Other / unclassified	200 mg	Oral
Subject	tenofovir alafenamide	Small molecule	25 mg	Oral

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

Summary

Timeline

Publications

Drugs

Indications