Low Dose Nivolumab in Adults Living With HIV on Antiretroviral Therapy
Trial Parameters
Brief Summary
The purpose of this study is to evaluate whether a single dose of Nivolumab in people living with HIV can reduce the latent reservoir. The latent HIV reservoir is a group of immune system cells in the body that are infected with HIV but are not actively producing new virus. This is the reason why people living with HIV are unable to stop their antiretroviral treatment.
Eligibility Criteria
Inclusion Criteria: * Documented HIV-1 infection; * Viral load \> 400 copies/mL prior to initiation of ART; * Weight ≥ 50 kg; * Ability and willingness to provide informed consent and to continue ART throughout the study; * Receiving combination ART for at least 2 years and being on the same ART regimen for at least 4 weeks at the screening visit; * HIV-1 plasma RNA \<50 copies/mL for \>2 years (documented on at least 2 occasions within the 2 years) and \<50 copies/mL at screening. Episodes of a single HIV plasma RNA 50-500 copies/mL will not exclude participation if the subsequent HIV plasma RNA was \<50 copies/mL; * CD4+ T cell counts \>500 cells/μL at screening; * Female participants if they meet one of the following criteria: * Is of non-child-bearing potential defined as either post-menopausal (12 months of spontaneous amenorrhea and ≥ 45 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy or, * Is of ch