Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 up to 52 weeks. |
|
| Part A: Group 2 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 a IM injections of GS-3242 (at a different dose than Group 1) and LEN up to 52 weeks. |
|
| Part A: Group 3 of B/F/TAF | Experimental | Participants will be randomized to continue to receive 50/200/25 mg of B/F/TAF daily for up to 52 weeks. |
|
| Part B: Group 4 (Conditional) 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 injection of GS-3242 and LEN (at different doses than Groups 1 and 2) up to 52 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GS-3242 Tablet | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gilead Clinical Study Information Center | Contact | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Midway Immunology and Research Center | Recruiting | Ft. Pierce | Florida | 34982 | United States | |
Not provided
| Label | URL |
|---|---|
| Gilead Clinical Trials Website | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Parallel Assignment (Part A randomized parallel groups; Part B (conditional) single-arm, non-randomized)
Not provided
Not provided
Not provided
Not provided
| GS-3242 Injection | Drug | Administered intramuscularly (IM) |
|
| Lenacapavir Tablet | Drug | Administered orally |
|
|
| Lenacapavir Injection | Drug | Administered IM |
|
|
| B/F/TAF | Drug | Administered orally |
|
| 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 | Week 52 |
| Part A: Change From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 35 | Baseline, Week 35 |
| Part A and Part B: Change From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 52 | 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 | Week 26 |
| Part B: Change From Baseline in CD4 Cell Count at Week 26 | Baseline, Week 26 |
| Part A: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) Through Week 35 | Up to Week 35 |
| Part A and Part B: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) Through Week 52 | Up to Week 52 |
| Part B: Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 26 | Up to Week 26 |
| Part A: Group 1 and 2:Trough Concentrations of GS-3242 and LEN at Week 18 | Week 18 |
| Part A: Group 1 and 2:Trough Concentrations of GS-3242 and LEN at Week 35 | 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 | Week 52 |
| Part B: Trough Concentrations at GS-3242 and LEN at Week 26 | Week 26 |
| North Texas Infectious Disease Consultants, P.A. |
| Recruiting |
| Dallas |
| Texas |
| 75246 |
| United States |
| Diagnostic Clinic of Longview | Recruiting | Longview | Texas | 75605 | United States |
| ID | Term |
|---|---|
| C000730993 | lenacapavir |
Not provided
Not provided
Not provided