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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05585307 | Study of Novel Antiretrovirals in Participants With HIV-1 | PHASE1 | COMPLETED | 49 | — | — | Oct 26, 2022 | Mar 18, 2024 | May 8, 2025 | 42 | United States, Dominican Republic +1 |
| Arm | Type | Description |
|---|---|---|
| Substudy 01: Cohort 1: Bavtavirine 675 mg (High-Fat Meal) | EXPERIMENTAL | Participants receive a single dose of bavtavirine 675 mg tablet with a high-fat meal on Day 1. After assessments on Day 11 or upon early termination (ET), the participants initiate a regimen of B/F/TAF, 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. |
| Substudy 01: Cohort 2: Bavtavirine 1200 mg (Low-Fat Meal) | EXPERIMENTAL | Participants receive a single dose of bavtavirine 1200 mg tablet with a low-fat meal on Day 1. After assessments on Day 11 or upon ET, the participants initiate a regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC) up to Day 39. |
| Substudy 01: Cohort 3: Bavtavirine 900 mg (High-Fat Meal) | EXPERIMENTAL | Participants receive bavtavirine 900 mg tablet with a high-fat meal on Days 1 and 2. After assessments on Day 11 or upon ET, the participants initiate a regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC) up to Day 39. |
| Substudy 02: Cohort 1: GS-1720 450 mg | EXPERIMENTAL | Participants receive a single dose of GS-1720 450 mg tablet on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiate a regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC) up to Day 60. |
| Substudy 02: Cohort 2: GS-1720 150 mg | EXPERIMENTAL | Participants receive a single dose of GS-1720 150 mg tablet on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiate a regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC) up to Day 60. |
| Substudy 02: Cohort 3: GS-1720 30 mg | EXPERIMENTAL | Participants receive a single dose of GS-1720 30 mg tablet on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiate a regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC) up to Day 60. |
| Substudy 02: Cohort 4: GS-1720 900 mg | EXPERIMENTAL | Participants receive a single dose of GS-1720 900 mg tablet on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiate a regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC) up to Day 60. |
| Substudy 03: Cohort 1: GS- 6212 100 mg | EXPERIMENTAL | Participants receive GS-6212 100 mg tablet twice daily on Days 1 through 10. After assessments on Day 11 or upon ET, the participants initiate a regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC) up to Day 25. |
| Name | Type | Description |
|---|---|---|
| Bavtavirine | DRUG | Administered orally |
| B/F/TAF | DRUG | Administered orally |
| Standard of Care (Substudy 01) | DRUG | Antiretroviral therapy, administered orally Non-NNRTIs, examples: ABC/DTG/3TC; DTG plus (TAF or TDF) plus (FTC or 3TC) |
| GS-1720 | DRUG | Administered orally |
| Standard of Care (Substudy 02) | DRUG | Antiretroviral therapy, administered orally Example INSTIs: DTG/ABC/3TC or DTG/3TC |
| GS-6212 | DRUG | Administered orally |
| Standard of Care (Substudy 03) | DRUG | Antiretroviral therapy, administered orally |
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...