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| ID | Type | Description | Link |
|---|---|---|---|
| 2026-526026-40 | Other Identifier | EU Trial (CTIS) Number |
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The study will have two portions: Phase 2 and Phase 3. Phase 2 will further have 2 parts: Part A and Part B.
The goal of Phase 2, Part A is to assess the effectiveness of study drugs GS-3242 plus Lenacapavir (LEN) versus Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF)), in people with HIV-1 (PWH) who are new to treatment. This will be done in Treatment Groups 1, 2 and 3 at Week 35.
The goal of Phase 2, Part B is to compare the effectiveness of study drugs, GS-3242 and LEN versus B/F/TAF in Groups 4 and 3 at Week 26.
The goal of Phase 3 is to assess the long-term effectiveness of study drug GS-3242 and LEN versus B/F/TAF, at Week 52.
The primary objectives of this study are:
Phase 2, Part A: To evaluate the efficacy of intramuscular (IM) GS-3242 plus IM LEN versus B/F/TAF in treatment-naive people with HIV-1 (PWH) in Treatment Groups 1, 2, and 3 at Week 35. Phase 2, Part B: To evaluate the efficacy of IM GS-3242 plus IM LEN versus B/F/TAF in treatment-naive PWH in Treatment Groups 4 and 3 at Week 26.
Phase 3: To evaluate the efficacy of IM GS-3242 plus IM LEN versus B/F/TAF in treatment-naive PWH at Week 52.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 2: Part A: Group 1 of GS-3242 + LEN | Experimental | 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 for at least 52 weeks. |
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| Phase 2: Part A: Group 2 of GS-3242 + LEN | Experimental | Participants will be randomized oral loading doses of GS-3242 in combination with LEN oral tablets, followed by IM injections of GS-3242 (at a different dose than Group 1) and LEN for at least 52 weeks. |
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| Phase 2: Part A: Group 3 of B/F/TAF | Experimental | Participants will be randomized to receive 50/200/25 mg of B/F/TAF daily for at least 52 weeks. |
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| Phase 2: Part B: Group 4 of GS-3242 + LEN | Experimental | Participants will be enrolled (non-randomized) to receive oral loading doses of GS-3242 in combination with LEN oral tablets, followed IM injections of GS-3242 and LEN (at different doses than Group 1 and 2) for at least 52 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GS-3242 Tablet | Drug | Administered orally |
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| Measure | Description | Time Frame |
|---|---|---|
| Phase 2: 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 | Week 35 | |
| Phase 2: Part B: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 26 as Determined by the US FDA Snapshot Algorithm | Week 26 | |
| Phase 3: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 52 as Determined by the US FDA Snapshot Algorithm | Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 2: Parts A and B: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 as Determined by the US FDA Snapshot Algorithm | Week 12 | |
| Phase 2: Parts A and B: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 52 as Determined by the US FDA Snapshot Algorithm |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gilead Clinical Study Information Center | Contact | 1-833-445-3230 (GILEAD-0) | leadClinicalTrials@gilead.com |
| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
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| ID | Term |
|---|---|
| C000730993 | lenacapavir |
| C000654125 | bictegravir, emtricitabine, tenofovir alafenamide, drug combination |
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| Phase 3: Group 1 of GS-3242 + LEN | Experimental | Participants will be randomized to receive oral loading doses of GS-3242 in combination with LEN oral tablets, followed by IM injections of GS-3242 and LEN for at least 104 weeks. |
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| Phase 3: Group 2 of B/F/TAF | Experimental | Participants will be randomized to receive 50/200/25 mg of B/F/TAF daily for at least 104 weeks. |
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| GS-3242 Injection | Drug | Administered intramuscularly (IM) |
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| Lenacapavir Tablet | Drug | Administered orally |
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| Lenacapavir Injection | Drug | Administered IM |
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| B/F/TAF | Drug | Administered orally |
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| Week 52 |
| Phase 2: Parts A and B: Change From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 12 | Baseline, Week 12 |
| Phase 2: Part A: Change From Baseline in CD4 Cell Count at Week 35 | Baseline, Week 35 |
| Phase 2: Parts A and B: Change From Baseline in CD4 Cell Count at Week 52 | Baseline, Week 52 |
| Phase 2: Part B: Change From Baseline in CD4 Cell Count at Week 26 | Baseline, Week 26 |
| Phase 2: Parts A and B: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) Through Week 12 | From first dose date up to Week 12 |
| Phase 2: Part A: Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 35 | Week 35 |
| Phase 2: Part B: Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 26 | From first dose date up to Week 26 |
| Phase 2: Parts A and B and Phase 3: Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 52 | From first dose date up to Week 52 |
| Phase 2: Part A: Groups 1 and 2: Trough Concentrations of GS-3242 and LEN at Week 18 | Week 18 |
| Phase 2: Part A: Groups 1 and 2: Trough Concentrations of GS-3242 and LEN at Week 35 | Week 35 |
| Phase 2: Part A and Part B: Trough Concentrations of GS-3242 and LEN at Week 52 | Week 52 |
| Phase 2: Part B: Trough Concentrations of GS-3242 and LEN at Week 26 | Week 26 |
| Phase 3: Proportion of Participants with HIV-1 RNA < 50 copies/mL at Week 104 as determined by the US FDA snapshot algorithm | Week 104 |
| Phase 3: Change From Baseline in CD4 Cell Count at Week 52 | Baseline, Week 52 |
| Phase 3: Change From Baseline in CD4 Cell Count at Week 104 | Baseline, Week 104 |
| Phase 3: Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 52 | From first dose up to Week 52 |
| Phase 3: Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 104 | From first dose up to Week 104 |