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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06071767 | Evaluation of Safety, Immunogenicity and Efficacy of a Triple Immune Regimen in Adults Initiated on ART During Acute HIV-1 | PHASE1 | RECRUITING | 36 | — | — | Apr 1, 2024 | Aug 1, 2029 | Feb 9, 2026 | 12 | United States, Brazil |
| Arm | Type | Description |
|---|---|---|
| Arm A: Active ChAdOx1 and MVA/HIVconsvX vaccines, vesatolimod and bnAbs | EXPERIMENTAL | - |
| Arm B: Placebos for vaccines, vesatolimod and bnAbs | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| ChAdOx1.tHIVconsv1 | BIOLOGICAL | Administered as 0.4 mL intramuscularly (IM) at Week 0 |
| ChAdOx1.HIVconsv62 | BIOLOGICAL | Administered as 0.3 mL IM at Week 0 |
| MVA.tHIVconsv3 | BIOLOGICAL | Administered as 0.3 mL IM at Week 4 |
| MVA.tHIVconsv4 | BIOLOGICAL | Administered as 0.5 mL IM at week 4 |
| Vesatolimod (VES) | DRUG | VES 6 mg administered orally once every 2 weeks for two doses, then VES 8 mg once every 2 weeks for 8 doses. Dose escalation may be held or the 8 mg dose may be reduced for intolerability for weeks 6 through 24. |
| GS-5423 | DRUG | Administered via intravenous (IV) infusion at week 7 |
| GS-2872 | DRUG | Administered via IV infusion at week 7 |
| Placebo | BIOLOGICAL | Placebos for vaccines, VES, and bnAbs |
Inclusion Criteria * Provision of written informed consent. * History of Initiation of combination ART within 90 days of acute HIV diagnosis * On ART for at least 12 months with no known ART interruption \>28 consecutive days within 12 months prior to Step 1 Study Entry * ART with an integrase inhi...