A Phase 2 interventional study of B/F/TAF and GS-3242 in HIV-1 Infection, sponsored by Gilead Sciences. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Gilead Sciences · Phase 2, Interventional, and Treatment
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.
Key Inclusion Criteria:
Key Exclusion Criteria:
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.
Drug: B/F/TAF
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.
Drug: GS-3242 · Drug: Lenacapavir
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.
Drug: GS-3242 · Drug: Lenacapavir
Tablet administered orally
Also known as: Biktarvy®
Tablet administered orally
Tablet administered orally
Also known as: LEN
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
Time frame: Week 24
Proportion of Participants With HIV-1 RNA ≥ 50 copies/mL at Weeks 12 as Determined by the US FDA-defined Snapshot Algorithm
Time frame: Week 12
Proportion of Participants With HIV-1 RNA ≥ 50 copies/mL at Weeks 48 as Determined by the US FDA-defined Snapshot Algorithm
Time frame: Week 48
Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 as Determined by the US FDA-defined Snapshot Algorithm
Time frame: Week 12
Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 as Determined by the US FDA-defined Snapshot Algorithm
Time frame: Week 24
Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm
Time frame: Week 48
Change From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 12
Time frame: Week 12
Change From Baseline in CD4 Cell Count at Week 24
Time frame: Week 24
Change From Baseline in CD4 Cell Count at Week 48
Time frame: Week 48
The Percentage of Participants Experiencing Treatment-Emergent Aadverse Events (TEAEs) Through Week 12
Time frame: Week 12
The Percentage of Participants Experiencing Treatment-Emergent Aadverse Events (TEAEs) Through Week 24
Time frame: Week 24
The Percentage of Participants Experiencing Treatment-Emergent Aadverse Events (TEAEs) Through Week 48
Time frame: Week 48
Pharmacokinetic (PK) Parameter: Cmax of GS-3242
Cmax is defined as the maximum observed concentration of drug.
Time frame: Up to 48 weeks
PK Parameter: Tmax of GS-3242
Tmax is defined as the time (observed time point) of Cmax.
Time frame: 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.
Time frame: 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.
Time frame: Up to 48 weeks
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Gilead Sciences