A Phase 2 interventional study of GS-3242 Tablet and GS-3242 Injection in HIV-1-infection, sponsored by Gilead Sciences. Recruiting at 55 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by Gilead Sciences · Phase 2, Interventional, and Treatment
The study will have two parts: Part A and Part B. In Part A, the goal of the study is to compare the effectiveness of switching to the study drugs GS-3242 plus Lenacapavir (LEN) versus continuing Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF)), in virologically suppressed people with HIV-1 (PWH) in treatment Group 1, 2 and 3 at Week 35. In Part B the goal of the study is to compare the effectiveness of switching to the study drugs, GS-3242 and LEN versus continuing B/F/TAF in Groups 4 and 3 at Week 26.
The primary objective of part A is to evaluate the efficacy of switching to intramuscular (IM) GS-3242 plus IM LEN versus continuing on B/F/TAF PWH who are virologically suppressed in treatment Groups 1, 2, and 3 at Week 35 and Part B is to evaluate the efficacy of switching to IM GS-3242 plus IM LEN versus continuing on B/F/TAF in PWH who are virologically suppressed in Treatment Groups 4 and 3 at Week 26.
Gilead Sciences is the lead sponsor of 680 studies on the registry; 24 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 249 (96%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Participants will be randomized to receive oral loading doses of GS-3242 in combination with LEN oral tablets, followed by intramuscular (IM) injections of GS-3242 and LEN up to 52 weeks.
Drug: GS-3242 Tablet · Drug: GS-3242 Injection · Drug: Lenacapavir Tablet · Drug: Lenacapavir Injection
Participants will be randomized to receive oral loading doses of GS-3242 in combination with LEN oral tablets, followed by a IM injections of GS-3242 (at a different dose than Group 1) and LEN up to 52 weeks.
Drug: GS-3242 Tablet · Drug: GS-3242 Injection · Drug: Lenacapavir Tablet · Drug: Lenacapavir Injection
Participants will be randomized to continue to receive 50/200/25 mg of B/F/TAF daily for up to 52 weeks.
Drug: B/F/TAF
Participants will be enrolled (non-randomized) to receive oral loading doses of GS-3242 in combination with LEN oral tablets, followed IM injection of GS-3242 and LEN (at different doses than Groups 1 and 2) up to 52 weeks.
Drug: GS-3242 Tablet · Drug: GS-3242 Injection · Drug: Lenacapavir Tablet · Drug: Lenacapavir Injection
Administered orally
Administered intramuscularly (IM)
Administered orally
Also known as: LEN
Administered IM
Also known as: LEN
Administered orally
Part A: Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 35 as Determined by the United States (US) Food and Drug Administration (FDA) Snapshot Algorithm
Time frame: Week 35
Part B: Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 26 as Determined by the US FDA Snapshot Algorithm
Time frame: Week 26
Part A and Part B: Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 52 as Determined by the US FDA Snapshot Algorithm
Time frame: Week 52
Part A: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 35 as Determined by the US FDA Snapshot Algorithm
Time frame: Week 35
Part A and Part B: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 52 as Determined by the US FDA Snapshot Algorithm
Time frame: Week 52
Part A: Change From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 35
Time frame: Baseline, Week 35
Part A and Part B: Change From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 52
Time frame: Baseline, Week 52
Part B: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 26 as Determined by the US FDA Snapshot Algorithm
Time frame: Week 26
Part B: Change From Baseline in CD4 Cell Count at Week 26
Time frame: Baseline, Week 26
Part A: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) Through Week 35
Time frame: Up to Week 35
Part A and Part B: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) Through Week 52
Time frame: Up to Week 52
Part B: Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 26
Time frame: Up to Week 26
Part A: Group 1 and 2:Trough Concentrations of GS-3242 and LEN at Week 18
Time frame: Week 18
Part A: Group 1 and 2:Trough Concentrations of GS-3242 and LEN at Week 35
Time frame: Week 35
Part A: Group 1 and 2 and Part B: Groups 1 and 2:Trough Concentrations of GS-3242 and LEN at Week 52
Time frame: Week 52
Part B: Trough Concentrations at GS-3242 and LEN at Week 26
Time frame: Week 26
Plan to share: No
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