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RECRUITING
NCT05187429
PHASE1/PHASE2

Low Dose Nivolumab in Adults Living With HIV on Antiretroviral Therapy

Sponsor: University of Melbourne

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

42

Start Date

2023-01-24

Completion Date

2029-01

Last Updated

2025-12-22

Healthy Volunteers

No

Conditions

Interventions

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.

Locations (2)

Alfred Hospital - Department of Infecious Diseases

Melbourne, Victoria, Australia

Tan Tock Seng Hospital

Singapore, Singapore