Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07001319 | Study of GS-3242 in Participants With HIV-1; Substudy-05 | PHASE1 | COMPLETED | 27 | — | — | May 29, 2025 | Apr 16, 2026 | May 11, 2026 | 28 | United States, Mexico +1 |
| Arm | Type | Description |
|---|---|---|
| Cohort 1: Single Dose of GS-3242 | EXPERIMENTAL | Participants in cohort 1 will receive single dose of GS-3242 450 mg on Days 1 and 2 in the fasted condition. After assessments on Day 11 or upon early termination (ET), the participants initiate a regimen of bictegravir/emtricitabine/tenofovir alafenamide (Biktarvy®) (BVY), or an alternative standard of care (SOC) antiretroviral (ART) regimen (example INSTI + NRTIs: dolutegravir (DTG)/abacavir (ABC)/3TC or DTG/3TC) up to Day 39. Following the completion of Cohort 1, additional cohorts may be opened for enrollment if further data are needed. Doses of GS-3242 will be based on safety and pharmacokinetic (PK) data from ongoing Phase 1a studies. |
| Name | Type | Description |
|---|---|---|
| GS-3242 | DRUG | Administered orally |
| BVY | DRUG | Administered orally |
| Standard of Care | DRUG | Antiretroviral therapy, administered orally Non-NNRTIs, examples: ABC/ DTG/3TC; DTG plus (TAF or TDF) plus (FTC or 3TC) |
Key Inclusion Criteria: All Substudies: * Plasma human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) ≥ 5000 copies/mL but ≤ 400,000 copies/mL at screening. * Cluster of differentiation 4 (CD4) cell count \> 200 cells/mm\^3 at screening. * Antiretroviral (ARV) treatment-naive or treatment...