Actively Recruiting
Low Dose Nivolumab in Adults Living With HIV on Antiretroviral Therapy
Led by University of Melbourne · Updated on 2025-12-22
42
Participants Needed
2
Research Sites
309 weeks
Total Duration
On this page
Sponsors
U
University of Melbourne
Lead Sponsor
T
The Alfred
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Low Dose Nivolumab in Adults Living With HIV on Antiretroviral Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Documented HIV-1 infection
- Viral load greater than 400 copies/mL before starting ART
- Weight of at least 50 kg
- Ability and willingness to provide informed consent and continue ART throughout the study
- Receiving combination ART for at least 2 years and on the same ART regimen for at least 4 weeks at screening
- HIV-1 plasma RNA less than 50 copies/mL for more than 2 years, documented on at least 2 occasions, and less than 50 copies/mL at screening
- CD4+ T cell counts greater than 500 cells/µL at screening
- Female participants either non-child-bearing potential or of child-bearing potential with negative pregnancy tests at screening and Day 0 and agreeing to use effective contraception from 14 days before infusion until study end
- Agreement by all participants not to participate in conception during the study
- Heterosexually active males willing to use effective contraception or have anatomical sterility confirmed prior to study entry
- For Singapore participants, agreement to abide by the Infectious Diseases Act regarding HIV control
You will not qualify if you...
- Active, known, or suspected autoimmune diseases
- History of interstitial lung disease or chronic obstructive pulmonary disease
- Type I diabetes mellitus
- Active malignancy or history of malignancy requiring systemic chemotherapy or surgery in the last 24 months, except certain skin cancers
- History of solid organ transplant (except approved corneal transplants)
- Active or previously treated active tuberculosis
- History of HIV-related opportunistic infection within the last year
- Prior immune reconstitution syndrome
- Serious infections within 30 days prior to study entry requiring systemic therapy
- Immune deficiency other than HIV
- Receipt of investigational drug or device within 6 months prior to study entry
- Treatment for hepatitis C virus within 6 months prior to study entry
- Previous treatment with immune checkpoint inhibitors or immunoglobulin therapy
- Use of immunomodulators, cytotoxic chemotherapy, experimental vaccines, or investigational therapy within 60 days prior to study entry or planned use during the study, with exceptions for stable low-dose glucocorticoids and inhaled or topical corticosteroids
- Severe hepatic impairment or unstable liver disease
- Intention to modify ART regimen during the study
- Active alcohol or substance use interfering with compliance
- Acute or chronic psychiatric problems affecting eligibility
- Other active, clinically significant medical conditions
- Pregnancy, breastfeeding, or unwillingness to use contraception as required
- Specific blood and coagulation abnormalities for Cohort A
- Laboratory abnormalities including low hemoglobin, neutrophil count, platelets, elevated liver enzymes, abnormal thyroid tests, positive hepatitis B or C tests, and others as specified
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Alfred Hospital - Department of Infecious Diseases
Melbourne, Victoria, Australia, 3181
Actively Recruiting
2
Tan Tock Seng Hospital
Singapore, Singapore, 308433
Actively Recruiting
Research Team
J
Jennifer Audsley, BAppSC(Hons), PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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