CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 49 enrolled
Drug / intervention
Bavtavirine +6 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05585307
NCT05585307Phase 1Completed
CompareCT.gov

An Umbrella Phase 1b, Open-label, Multi-Cohort Study to Evaluate Safety, Pharmacokinetics, and Antiviral Activity of Novel Antiretrovirals in Participants With HIV-1

Gilead Sciences·interventional·Posted Oct 18, 2022·Updated May 8, 2025

In Brief

A Phase 1 clinical trial evaluating Bavtavirine, B/F/TAF, and 5 other interventions for HIV-1-infection. Completed, enrolled 49 participants across 42 sites in 3 countries.

Detailed Summary

Master protocol: The goal of this master clinical trial study is to learn how novel antiretrovirals (medicines that stop the virus from multiplying) affect the human immunodeficiency virus-1 (HIV-1) infection in people living with HIV (PWH). Substudy-01 (GS-US-544-5905-01) will evaluate bavtavirine in PWH. Substudy-02 (GS-US-544-5905-02) will evaluate GS-1720 in PWH. Substudy-03 (GS-US-544-5905-03) will evaluate GS-6212 in PWH.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV-1-infection
CountriesDominican Republic, Thailand, United States
Collaborators--

Timeline

Phase 1CompletedFinished
2023202420252026
First PostedOct 18, 2022
Enrollment StartOct 26, 2022
Primary CompletionFeb 17, 2024
Study CompletionMar 18, 2024
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 3.7 years ago

Interventions

Bavtavirinedrug

Administered orally

B/F/TAFdrug

Administered orally

Standard of Care (Substudy 01)drug

Antiretroviral therapy, administered orally Non-NNRTIs, examples: ABC/DTG/3TC; DTG plus (TAF or TDF) plus (FTC or 3TC)

GS-1720drug

Administered orally

Standard of Care (Substudy 02)drug

Antiretroviral therapy, administered orally Example INSTIs: DTG/ABC/3TC or DTG/3TC

GS-6212drug

Administered orally

Standard of Care (Substudy 03)drug

Antiretroviral therapy, administered orally