RecruitingPhase 1Phase 2NCT05187429

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)


Sponsor

University of Melbourne

Enrollment

42 participants

Start Date

Jan 24, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing low-dose nivolumab (an immunotherapy drug) in adults living with HIV who are on stable antiretroviral therapy (ART). The goal is to see if this drug can reduce the "HIV reservoir" — the hidden pool of HIV that persists even when viral load is undetectable. **You may be eligible if...** - You have HIV-1 infection and have been on the same antiretroviral treatment for at least 4 weeks - Your HIV viral load has been undetectable (below 50 copies/mL) for at least 2 years - Your CD4+ cell count is above 500 cells/μL - You weigh at least 50 kg - You are willing to use effective contraception if of reproductive potential **You may NOT be eligible if...** - You have an active autoimmune disease - You have a history of organ transplant or chronic lung disease (COPD) - You have type 1 diabetes - You have had an HIV-related opportunistic infection within the past 2 years - You have previously received an immune checkpoint inhibitor - You are pregnant or breastfeeding - You have active tuberculosis or active hepatitis B Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNivolumab 10 MG/ML [Opdivo]

Cohort A: Dose escalation phase: Nivolumab will be administered intravenously as a single dose in the dose escalation phase.

DRUGNivolumab 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.

DRUGSaline

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

View Full Details on ClinicalTrials.gov

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NCT05187429


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