RV630 - Approach to Control HIV With Immune Enhancement and Vaccination (ACHIEV
Trial Parameters
Brief Summary
This is a phase I, randomized, double-blind, placebo-controlled clinical trial to investigate the safety of VRC07-523LS and PGDM1400LS in combination with ChAdOx1.tHIVconsv1, ChAdOx1.HIVconsv62 prime, MVA.tHIVconsv4 and A244d11gp120/ALFQ vaccination, and the impact on viral load setpoint during analytic treatment interruption (ATI) in people living with human immunodeficiency virus-1 (HIV-1, PLWH) who have initiated or will initiate antiretroviral therapy (ART) during acute HIV-1 infection (AHI).
Eligibility Criteria
Inclusion/Exclusion Step 1 Inclusion Criteria (Groups 1 and 2 only) Participants are eligible to be included in the protocol Step 1 only if all of the following criteria are met: 1. Thai National 2. Age ≥18 and ≤60 years of age 3. Can read and write Thai 4. Able and willing to provide written informed consent 5. Confirmed HIV-1 infection (nucleic acid testing \[NAT\] and/or HIV-1 serology positive with confirmatory quantitative HIV-1 viral load) and started ART during acute infection 6. Uninterrupted treatment with ART (no interruption of ART for ≥7 consecutive days or longer) since ART initiation, for ≥ 48 weeks. 7. Currently on integrase inhibitor-based ART regimen (excluding long-acting injectable regimens) and no recent (≤8 weeks prior to screening) changes to ART regimen. a. There must be at least one documented plasma HIV-1 RNA \<50 cps/mL after the last ART change prior to screening 8. Must be medically stable as confirmed by medical history, physical examination, vital signs, a