
NIVO-LD
Study type | Summary | Inclusion Criteria | Participation requirements | Status |
2 phase study. Phase 1: dose finding study Phase 2: Randomised placebo controlled study | The NIVO-LD study is looking at effect of a single low dose of nivolumab (a drug designed to boost immune responses) on the latent HIV reservoir and HIV immune responses in a 5-week treatment interruption. This study involves a closely monitored 5-week treatment interruption. There are strict criteria to restart HIV treatment to ensure participant safety. | · HIV+ · Adults 18-65 years · On HIV treatment for >2 years · plasma RNA < 50 copies/mL for > 2 years · CD4 >500 · Weight >50kg | Phase 1: Participants will receive a single intravenous infusion of nivolumab followed by blood tests and two fine needle biopsies (a sample from a gland in the groin) to determine the best dose of drug to use for phase 2. Phase 2: Participants will receive a single intravenous infusion of nivolumab or placebo followed by a 5 week treatment interruption. | Currently recruiting |
Study contact
Contact: Alfred Clinical Research Unit on 03 9076 6908 or clinresearch@alfred.org.au