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NCT03960645 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 62
- Enrollment target
NCT03960645 is a Phase 1 study that has completed, run by Gilead Sciences. The registered enrollment target is 62 participants.
The verdict
NCT03960645, a Phase 1 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 62 participants
- Enrollment target
Study 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.
Interventions
- DRUG B/F/TAF
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2019-06-28 |
| Est. Completion | 2022-08-18 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03960645
The ClinicalTrials.gov registry entry for NCT03960645 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 62 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which B/F/TAF is the first listed.
NCT03960645 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03960645 about?
NCT03960645 is a clinical study titled "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 trimest...
What is the current status of trial NCT03960645?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 62 participants. The study started on 2019-06-28. Estimated completion is 2022-08-18.
What interventions are being tested in trial NCT03960645?
The interventions under investigation include: B/F/TAF (DRUG).
Who is sponsoring clinical trial NCT03960645?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
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