HIV-1-infection
Conditions
Brief summary
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.
Interventions
DRUGGS-3242 Tablet
Administered orally
Administered intramuscularly (IM)
Administered orally
Administered IM
DRUGB/F/TAF
Administered orally
Sponsors
Gilead Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * HIV-1 ribonucleic acid (RNA) ≥ 500 copies/mL at screening. * Antiretroviral (ARV) treatment-naive, except for prior use of oral daily pre-exposure prophylaxis (PrEP) or postexposure prophylaxis (PEP) up to 1 month prior to screening. Key
Exclusion criteria
* Prior usage of, or exposure to LEN or GS-3242 * Prior use of any long-acting parenteral ARV therapy (ART) medications such as monoclonal antibodies or broadly neutralizing antibodies targeting HIV-1, injectable cabotegravir (including oral cabotegravir lead-in), or injectable rilpivirine. Note: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | 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 | 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 |
Contacts
CONTACTGilead Clinical Study Information Center
STUDY_DIRECTORGilead Study Director
Gilead Sciences
Outcome results
None listed