HIV-1 InfectionPhase 2NCT07841990
Substudy-01: A Study of Long-Acting HIV-1 Treatments Taken by Mouth in People With HIV-1 With Undetectable Virus Levels
A Phase 2 study testing B/F/TAF, GS-3242 and Lenacapavir in people with HIV-1 Infection, run by Gilead Sciences at 2 sites in United States.
Trial summary
Master Protocol: The main goal of this master clinical study is to evaluate the safety, tolerability, efficacy, and pharmacokinetic (PK) of long-acting oral (LAO) regimens in people with HIV-1 (PWH). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1 Infection
- What is being tested?
- B/F/TAF, GS-3242 and Lenacapavir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Oct 2026to Jul 2033
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals assigned male or female at birth, 18 years of age or older, able to understand and give written informed consent and comply with treatment and follow-up.
- Individuals assigned male or female at birth who are of childbearing potential and engage in heterosexual intercourse must agree to use approved method(s) of contraception.
- Negative serum pregnancy test at screening and negative urine test at enrollment.
- Receiving B/F/TAF for ≥ 6 months prior to screening.
- Documented plasma HIV-1 RNA < 50 copies/mL for ≥ 6 months before and at screening.
- No resistance to GS-3242 (integrase mutation Q148H/K/R plus at least 2 of the following integrase mutations: L74I/M, T97A, E138A/K/T, or G140A/C/S) on available historical resistance reports.
- CD4 ≥ 200 cells/mm^3 at screening
Who cannot join
- Plans to breastfeed during the study period and 60 days following the last dose of study intervention.
- History of virologic failure while on an integrase strand-transfer inhibitor-based regimen.
- Creatinine clearance according to the Cockcroft-Gault formula < 60 mL/min.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Gilead Clinical Study Information Center contact
United States2 sites, 2 recruiting
- Recruiting
Midway Immunology and Research Center
Ft. Pierce, Florida, 34982
- Recruiting
The Crofoot Research Center, INC
Houston, Texas, 77098
About this study
Official title: A Platform, Active-Controlled Study Evaluating the Safety and Efficacy of Long-Acting Oral Regimens in People With HIV-1; Substudy-01: Phase 2, Open-Label, Weekly, Long-Acting, Oral Regimens in Virologically Suppressed People With HIV-1
Master Protocol: The main goal of this master clinical study is to evaluate the safety, tolerability, efficacy, and pharmacokinetic (PK) of long-acting oral (LAO) regimens in people with HIV-1 (PWH).
The main goal of this Substudy-01 is to assess the safety, tolerability, effectiveness, and PK of switching to weekly LAO regimens, including GS-3242 + LEN, versus continuing on once daily oral bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF; coformulated; Biktarvy®) in PWH with controlled HIV infection, B/F/TAF for at least 6 months prior to study start.
The primary objective is to evaluate the efficacy of switching to each LAO regimen versus continuing B/F/TAF in virologically suppressed PWH at Week 24.
- Conditions
- HIV-1 Infection
- Being tested
- B/F/TAF, GS-3242, Lenacapavir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B/F/TAFDrug
Also called Biktarvy®
Tablet administered orally
GS-3242Drug
Tablet administered orally
LenacapavirDrug
Also called LEN
Tablet administered orally
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm A: B/F/TAF | Active comparator | Participants will receive B/F/TAF 50/200/25 mg once daily for at least 48 weeks.
After Week 48, participants in the Randomized Phase may be offered to continue to receive study drug in the Extension Phase. Receives: Drug: B/F/TAF |
| Treatment Arm B: GS-3242 + LEN | Experimental | Participants will be randomized to oral loading dose of GS-3242 in combination with LEN, followed by a once-weekly oral combination regimen of GS-3242 and LEN (at a different dose than Treatment C), administered concomitantly for at least 48 weeks.
After Week 48, participants in the Randomized Phase may be offered to continue to receive study drug in the Extension Phase. Receives: Drug: GS-3242; Drug: Lenacapavir |
| Treatment Arm C: GS-3242 + LEN | Experimental | Participants will be randomized to oral loading dose of GS-3242 in combination with LEN, followed by a once-weekly oral combination regimen of GS-3242 and LEN (at a different dose than Treatment Arm B), administered concomitantly for at least 48 weeks.
After Week 48, participants in the Randomized Phase may be offered to continue to receive study drug in the Extension Phase. Receives: Drug: GS-3242; Drug: Lenacapavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants With HIV-1 Ribonucleic Acid (RNA) ≥ 50 copies/mL at Week 24 as Determined by the United States (US) Food and Drug Administration (FDA)-Defined Snapshot Algorithm
Measured: Week 24
Secondary outcomes (15)
Proportion of Participants With HIV-1 RNA ≥ 50 copies/mL at Weeks 12 as Determined by the US FDA-defined Snapshot Algorithm
Measured: Week 12
Proportion of Participants With HIV-1 RNA ≥ 50 copies/mL at Weeks 48 as Determined by the US FDA-defined Snapshot Algorithm
Measured: Week 48
Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 as Determined by the US FDA-defined Snapshot Algorithm
Measured: Week 12
Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 as Determined by the US FDA-defined Snapshot Algorithm
Measured: Week 24
Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm
Measured: Week 48
Change From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 12
Measured: Week 12
Change From Baseline in CD4 Cell Count at Week 24
Measured: Week 24
Change From Baseline in CD4 Cell Count at Week 48
Measured: Week 48
The Percentage of Participants Experiencing Treatment-Emergent Aadverse Events (TEAEs) Through Week 12
Measured: Week 12
The Percentage of Participants Experiencing Treatment-Emergent Aadverse Events (TEAEs) Through Week 24
Measured: Week 24
The Percentage of Participants Experiencing Treatment-Emergent Aadverse Events (TEAEs) Through Week 48
Measured: Week 48
Pharmacokinetic (PK) Parameter: Cmax of GS-3242
Cmax is defined as the maximum observed concentration of drug.
Measured: Up to 48 weeks
PK Parameter: Tmax of GS-3242
Tmax is defined as the time (observed time point) of Cmax.
Measured: Up to 48 weeks
PK Parameter: Ctau of GS-3242
Ctau is defined as the observed drug concentration at the end of the dosing interval.
Measured: Up to 48 weeks
PK Parameter: AUCtau of GS-3242
AUCtau is defined as the area under the concentration versus time curve over the dosing interval.
Measured: Up to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start1 Oct 2026
- Primary completionAug 2027 (estimated)
- Study completionJul 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1 InfectionStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07841990
- Sponsor's protocol ID
- GS-US-782-8079-01
- Status last verified
- Oct 2026
- First submitted
- 21 Sep 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No