Low Dose Nivolumab in Adults Living With HIV on Antiretroviral Therapy — NIVO-LD  

HIV I Infection Clinical Trial

Official title: Safety, Immunogenicity and Efficacy of Low Dose Nivolumab in Adults Living With HIV on Antiretroviral Therapy (ART)

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

This study consists of 2 Parts.

Part 1 is a dose escalation phase. This phase is open-label, single dose titration study in adult people living with HIV. There are 3 stages: a screening stage of up to 14 days; on study study treatment stage, where Nivolumab will be administered on Day 7 and a follow-up stage of 126 days (4 months). The maximum total duration on study for each participant enrolled in this phase is 140 days (4.5 months).

Part 2 is a double-blind, randomized, placebo controlled clinical trial of a single fixed dose of Nivolumab administered intravenous (IV) infusion compared with placebo in adult people living with HIV. This part of the study will consist of 3 stages: a screening stage of up to 14 days; on study study treatment stage, where Nivolumab/placebo will be administered on Day 0, followed by a follow-up period which includes a 5-week pre-planned analytical treatment interruption (where antiretroviral therapy (ART) is ceased), before the participant re-commences ART. The maximum total duration on study for each participant enrolled in this phase is 200 days (approximately 6.5 months). ;

Related Conditions & MeSH terms

• HIV I Infection

• NCT number: NCT05187429
• Study type: Interventional
• Source: University of Melbourne
• Contact: Barbara Scher
• Phone: +61 (0)3 8344 0770
• Email: barbara.scher@unimelb.edu.au
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: January 24, 2023
• Completion date: January 2026