Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Bavtavirine · 1 trial · 1 indication
| 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...
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Bavtavirine is an investigational small molecule being developed for the treatment of HIV-1 infection. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied in participants with HIV-1 infection.
Bavtavirine is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for HIV-1 infection.
Bavtavirine is in Phase 1 clinical development. It is an investigational drug and has not yet received regulatory approval. The drug is being studied for the treatment of HIV-1 infection, and its safety and efficacy are being evaluated in early-stage clinical trials.
Bavtavirine has been studied in one clinical trial, identified as NCT05585307, titled 'Study of Novel Antiretrovirals in Participants With HIV-1'. This Phase 1 trial was completed and enrolled 49 participants across the United States, Dominican Republic, and Thailand. The trial was controlled but not randomized or double-blinded.
Bavtavirine is a small molecule being developed as an antiretroviral for HIV-1 infection. The specific molecular target of Bavtavirine has not been disclosed in available information. As an antiretroviral, it is intended to interfere with the HIV-1 virus's ability to replicate, but the exact mechanism of action is not specified.