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Low Dose Nivolumab in Adults Living With HIV on Antiretroviral Therapy

NCT05187429 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2025-12-22

No results posted yet for this study

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.

Conditions

  • HIV I Infection

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.

Sponsors & Collaborators

Principal Investigators

  • Sharon Lewin · University of Melbourne

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-24
Primary Completion
2029-01-31
Completion
2029-01-31

Countries

  • Australia
  • Singapore

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05187429 on ClinicalTrials.gov