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Low Dose Nivolumab in Adults Living With HIV on Antiretroviral Therapy
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.
Study details:
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 126 days (4 months). The maximum total duration on study for each participant enrolled in this phase is 140 days (4. 5 months).
Part 2 is a double-blind, randomized, placebo controlled clinical trial of a single fixed dose of 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 14 days; on study study treatment stage, where Nivolumab/placebo will be administered on Day 0, followed by a follow-up period which includes a 5-week pre-planned 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 200 days (approximately 6.
5 months).
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2023-01-24
Primary completion: 2026-01-01
Study completion finish: 2026-01-01
Study type
TREATMENT
Phase
PHASE1
PHASE2
Trial ID
NCT05187429
Intervention or treatment
DRUG: Nivolumab 10 MG/ML [Opdivo]
DRUG: Nivolumab 10 MG/ML [Opdivo]
DRUG: Saline
Conditions
- • HIV I Infection
Find a site
Closest Location:
Alfred Hospital - Department of Infecious Diseases
Research sites nearby
Select from list below to view details:
Alfred Hospital - Department of Infecious Diseases
Melbourne, Victoria, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Dose escalation phase (Cohort A)
| DRUG: Nivolumab 10 MG/ML [Opdivo]
|
EXPERIMENTAL: Randomization phase (Cohort B)
| DRUG: Nivolumab 10 MG/ML [Opdivo]
|
PLACEBO_COMPARATOR: Randomization phase comparator (Cohort B)
| DRUG: Saline
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Number of participants with treatment-emergent adverse events enrolled in Cohort A | Incidence and severity of Adverse Events (defined as Common Terminology Criteria (CTC) grade 3 or higher according to the Division of AIDS (DAIDS) grading table) that are definitely, probably or possibly related to study treatment during the study period | 18 weeks |
Number of participants with treatment-emergent adverse events enrolled in Cohort B | Incidence and severity of Adverse Events (defined as CTC grade 3 or higher according to the DAIDS grading table) that are definitely, probably or possibly related to study treatment during the study period | 24 weeks |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Change in PD-1 receptor occupancy in peripheral blood following a single low dose of nivolumab in participants enrolled in Cohort A | Time course change in the percentage PD-1 receptor occupancy on T-cells in peripheral blood determined by flow cytometry. Nivolumab infusion occurs on Day 7 study visit | Day 7, Day 14, Day 21, Day 35, Day 63, Day 91, Day 126 |
Change in PD-1 receptor occupancy in lymph node T-cells following a single low dose of nivolumab in participants enrolled in Cohort A. | Time course change in the percentage PD-1 receptor occupancy on T-cells in inguinal lymph node T-cells determined by flow cytometry | Day 21 |
Cohort A: T-cell responses to Gag peptides | Number of cluster of differentiation 4 (CD4) and/or cluster of differentiation 8 (CD8) T-cells responses to Gag peptides by intracellular cytokine staining both in peripheral blood and lymph nodes | Day 0, Day 126 |
Cohort A: T-cell responses to Pol/Env/Nef peptides | Number of CD4 and/or CD8 T-cells responses to Pol/Env/Nef peptides by intracellular cytokine staining in both peripheral blood and lymph nodes | Day 0, Day 126 |
Change in PD-1 receptor occupancy in peripheral blood following a single low dose of nivolumab in participants enrolled in Cohort B | Time course change in the percentage PD-1 receptor occupancy on T-cells in peripheral blood determined by flow cytometry. Nivolumab/placebo infusion occurs on Day 0 (baseline) visit | Day 0, Day 7, Day 28, Day 168 |
Cohort B: HIV RNA | Proportion of participants with a viral load (HIV RNA) \> 50 and \> 1000c/ml measured weekly during a 5-week ART interruption, which starts on Day 7 and ends on Day 35 | 5 weeks |
Cohort B: viral rebound | Number of participants who experience a viral rebound (defined as first viral load \> 50 copies/mL) during the 5 week ATI period which starts on Day 7 and ends on Day 35 | 5 weeks |
Cohort B: T-cell responses to Gag peptides | Number of CD4 and/or CD8 T-cells responses to Gag peptides by intracellular cytokine staining both in peripheral blood and lymph nodes | Day 7, Day 168 |
Cohort B: T-cell responses to Pol/Env/Nef peptides | Number of CD4 and/or CD8 T-cells responses to Pol/Env/Nef peptides by intracellular cytokine staining in both peripheral blood and lymph nodes | Day 7, Day 168 |
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