Low Dose Nivolumab in Adults Living With HIV on Antiretroviral Therapy

Sponsor
University of Melbourne
Study ID
NCT05187429
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • HIV I Infection

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jan 24, 2023
Status verified
Dec 2025
Primary completion
Jan 31, 2029
Completion
Jan 31, 2029

Study Design

Enrollment
42 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose escalation phase (Cohort A)
    Drug: Nivolumab Dose form: infusion Dose route: intravenous Dosage: 0.1, 0.3 or 1.0 mg/kg Duration: Single dose administered on Study Day 7
  • Experimental: Randomization phase (Cohort B)
    Drug: Nivolumab Dose form: infusion Dose route: intravenous Dosage: 1.0mg/kg (determined from Cohort A) Duration: single dose administered on Day 0 (baseline)
  • Placebo Comparator: Randomization phase comparator (Cohort B)
    Drug: Nivolumab Comparator: saline Dose form: infusion Dose route: intravenous Dosage: 1.0mg/kg of Nivolumab Duration: single dose administered on Day 0 (baseline)

Primary Outcome Measure

Number of participants with treatment-emergent adverse events enrolled in Cohort A [ Time Frame: 23 weeks ]

Central Contacts