NCT05187429

Low Dose Nivolumab in Adults Living With HIV on Antiretroviral Therapy

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: University of Melbourne · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 up to 168 days (6 months), depending on the dose level. The maximum total duration on study for each participant enrolled in this phase is 140 days (6.3 months). Part 2 is a double-blind, randomized, placebo controlled clinical trial of a single fixed dose of 1.0mg/kg 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 21 days; on study study treatment stage, where Nivolumab/placebo will be administered on Day 0, followed by a maximum of 6months of an 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 241 days (approximately 8 months).

Conditions

• HIV I Infection

Interventions

Type	Name	Description
DRUG	Nivolumab 10 MG/ML [Opdivo]	Cohort A: Dose escalation phase: Nivolumab will be administered intravenously as a single dose in the dose escalation phase.
DRUG	Nivolumab 10 MG/ML [Opdivo]	Cohort B: Randomization phase: Nivolumab will be administered intravenously as a fixed single dose (1.0 mg/kg) in the randomization phase.
DRUG	Saline	Cohort B: Randomisation phase: Saline will be administered intravenously as a single dose in the randomisation arm.

Timeline

• Start date: 2023-01-24
• Primary completion: 2029-01-01
• Completion: 2029-01-01
• First posted: 2022-01-11
• Last updated: 2025-12-22

Locations

2 sites across 2 countries: Australia, Singapore