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Study of Novel Antiretrovirals in Participants With HIV-1

NCT05585307 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2025-05-08

Study results available
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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.

Conditions

Interventions

DRUG

Bavtavirine

Administered orally

DRUG

B/F/TAF

Administered orally

DRUG

Standard of Care (Substudy 01)

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

DRUG

GS-1720

Administered orally

DRUG

Standard of Care (Substudy 02)

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

DRUG

GS-6212

Administered orally

DRUG

Standard of Care (Substudy 03)

Antiretroviral therapy, administered orally

Sponsors & Collaborators

Principal Investigators

  • Gilead Study Director · Gilead Sciences

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-26
Primary Completion
2024-02-17
Completion
2024-03-18
FDA Drug
Yes

Countries

  • United States
  • Dominican Republic
  • Thailand

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05585307 on ClinicalTrials.gov