A Clinical Trial of Combination HIV-Specific Broadly Neutralizing Monoclonal Antibodies Combined With ART Initiation During Acute HIV Infection to Induce HIV Remission
Summary
A5388 is a phase II, two-arm, randomized, double-blind, placebo-controlled study that will enroll 48 antiretroviral therapy (ART)-naïve adults with acute HIV infection (AHI) in order to determine whether: * Administration of combination HIV-specific broadly neutralizing antibody (bNAb) therapy in addition to ART during acute HIV infection (AHI) will be safe. * Participants who receive combination bNAb therapy in addition to ART during AHI will be more likely to demonstrate a delay in time to HIV-1 RNA ≥1,000 copies/mL for 4 consecutive weeks compared to participants who receive placebo plus ART. * Participants who receive combination bNAb therapy in addition to ART during AHI will demonstrate lower viral reservoirs and enhanced HIV-specific immunity compared to participants who receive placebo plus ART.
Timeline
- Start
- 2024-08-19
- Primary completion
- 2028-04-06
- Completion
- 2028-09-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PGT121.414.LS | Monoclonal antibody | 5 mg/kg | Intravenous |
| Subject | VRC07-523LS | Monoclonal antibody | 10 mg/kg | Intravenous |
| Background | bictegravir | Small molecule | 50 mg | Oral |
| Background | emtricitabine | Other / unclassified | 200 mg | Oral |
| Background | tenofovir alafenamide | Small molecule | 25 mg | Oral |
Indications
No indication recorded.