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)

Low Dose Nivolumab in Adults Living With HIV on Antiretroviral Therapy (NCT05187429) is a Phase 1 / Phase 2 interventional studying HIV I Infection, sponsored by University of Melbourne. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For HIV I Infection, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 42 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - Documented HIV-1 infection; - Viral load \> 400 copies/mL prior to initiation of ART; - Weight ≥ 50 kg; - Ability and willingness to provide willing to sign a consent form and to continue ART throughout the study; - Receiving combination ART for at least 2 years and being on the same ART regimen for at least 4 weeks at the screening visit; - HIV-1 plasma RNA \<50 copies/mL for \>2 years (documented on at least 2 occasions within the 2 years) and \<50 copies/mL at screening. Episodes of a single HIV plasma RNA 50-500 copies/mL will not exclude participation if the subsequent HIV plasma RNA was \<50 copies/mL; - CD4+ T cell counts \>500 cells/μL at screening; - Female participants if they meet one of the following criteria: - Is of non-child-bearing potential defined as either post-menopausal (12 months of spontaneous amenorrhea and ≥ 45 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy or, - Is of child-bearing potential with a negative pregnancy test at both Screening and Day 0 and agrees to use one of the following methods of contraception to avoid pregnancy from 14 days prior to the first infusion until the end of the study: - Complete abstinence from penile-vaginal intercourse; - Double barrier method (male condom/spermicide, male condom/diaphragm, diaphragm/spermicide); - Any intrauterine device (IUD) with published data showing that the expected failure rate is \<1% per year; - Male partner sterilization confirmed prior to the female participant's entry into the study, and this male is the sole partner for that participant; - Approved hormonal contraception (Where other medications to be used in the study (e.g., efavirenz and darunavir) are known, or are likely, to significantly interact with systemic contraceptives, resulting in decreased efficacy of the contraceptive, then alternative methods of non-hormonal contraception are recommended); ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Documented HIV-1 infection; * Viral load \> 400 copies/mL prior to initiation of ART; * Weight ≥ 50 kg; * Ability and willingness to provide informed consent and to continue ART throughout the study; * Receiving combination ART for at least 2 years and being on the same ART regimen for at least 4 weeks at the screening visit; * HIV-1 plasma RNA \<50 copies/mL for \>2 years (documented on at least 2 occasions within the 2 years) and \<50 copies/mL at screening. Episodes of a single HIV plasma RNA 50-500 copies/mL will not exclude participation if the subsequent HIV plasma RNA was \<50 copies/mL; * CD4+ T cell counts \>500 cells/μL at screening; * Female participants if they meet one of the following criteria: * Is of non-child-bearing potential defined as either post-menopausal (12 months of spontaneous amenorrhea and ≥ 45 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy or, * Is of child-bearing potential with a negative pregnancy test at both Screening and Day 0 and agrees to use one of the following methods of contraception to avoid pregnancy from 14 days prior to the first infusion until the end of the study: * Complete abstinence from penile-vaginal intercourse; * Double barrier method (male condom/spermicide, male condom/diaphragm, diaphragm/spermicide); * Any intrauterine device (IUD) with published data showing that the expected failure rate is \<1% per year; * Male partner sterilization confirmed prior to the female participant's entry into the study, and this male is the sole partner for that participant; * Approved hormonal contraception (Where other medications to be used in the study (e.g., efavirenz and darunavir) are known, or are likely, to significantly interact with systemic contraceptives, resulting in decreased efficacy of the contraceptive, then alternative methods of non-hormonal contraception are recommended); * Any other method with published data showing that the expected failure rate is \<1% per year. Note: If using one of the described contraception methods it must be used consistently, in accordance with the approved product label and all female participants must be willing to undergo urine pregnancy tests as specified in the Schedule of Procedures. * All participants must agree not to participate in a conception process (e.g. active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization, egg donation) during the study; * Heterosexually active male if they are; * willing to use an effective method of contraception (anatomical sterility in self that is confirmed prior to study entry) or * agree on the use of an effective method of contraception with an effective failure rate of \< 1% by his partner (hormonal contraception, intra-uterine device (IUD), or anatomical sterility) from the day of the first infusion until the end of study (as long as plasma viral load \<20c/mL). * Singapore only: all participants must understand and agree to abide by the Infectious Diseases Act, in particular Part 4 'Control of HIV infection' inclusive of section 23 'Sexual activity by person with HIV infection' Exclusion Criteria: * Active, known and suspected autoimmune disease (including but not limited to including but not limited to inflammatory bowel diseases, scleroderma, severe psoriasis, myocarditis, uveitis, pneumonitis, systemic lupus erythematosus, rheumatoid arthritis, optic neuritis, myasthenia gravis, adrenal insufficiency, hypothyroidism and/or hyperthyroidism, autoimmune thyroiditis, sarcoidosis, and vitiligo); * History of interstitial lung disease; * History of chronic obstructive pulmonary disease (COPD); * Type I diabetes mellitus; * Active malignancy or history of malignancy requiring systemic chemotherapy or surgery in the preceding 24 months; exception -history of excised localized non-melanomatous skin cancers (squamous cell carcinoma, basal cell carcinoma); * History of solid organ transplant. Note Individuals with prior corneal transplants may be allowed to enroll after discussion with and approval from the study principal investigator; * Active or previously treated active TB; * History of HIV-related opportunistic infection within the last years prior to study entry; * Prior history of immune reconstitution syndrome (IRIS); * Current, chronic, acute or recurrent bacterial, fungal or viral (other than HIV) infections that are serious, in the opinion of the investigator, and require systemic therapy within 30 days prior to study entry; * Immune deficiency other than that caused by HIV infection; * Received investigational drug or device within 6 months prior to study entry * Treatment for hepatitis C virus (HCV) within 6 months prior to study entry; * History of previous treatment with an immune checkpoint inhibitor; * History of prior immunoglobulin (IgG) therapy; * Use of immunomodulators (e.g., interleukins, interferons, cyclosporine), systemic cytotoxic chemotherapy, experimental vaccines or investigational therapy within 60 days prior to study entry or intent to use immunomodulators during the study. NOTE: Participants receiving stable physiologic glucocorticoid doses, defined as prednisolone less than or equal to 10 mg/day or the equivalent, will not be excluded. Stable physiologic glucocorticoid doses should not be discontinued for the duration of the study. In addition, participants receiving inhaled or topical corticosteroids will not be excluded; * Any other current or prior therapy which, in the opinion of the investigators, would make the individual unsuitable for the study or influence the results of the study; * Participants with severe hepatic impairment (Class C) as determined by Child-Pugh classification; * Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones); * Participants who intend to modify their ART regimen within the study period; * Active alcohol or substance use that in the opinion of the investigator will prevent adequate compliance with study procedures; * Any acute or chronic psychiatric problems that, in the opinion of the investigator, make the participant ineligible for participation; * Any active, clinically significant medical condition not otherwise covered; * Women who are pregnant or breastfeeding or Women of Child Bearing Potential (WOCBP) who are unwilling or unable to use an acceptable method of contraception to avoid pregnancy as specified in the inclusion criteria; * Men of reproductive potential who are unwilling or unable to use an acceptable method of contraception to avoid pregnancy as specified in the inclusion criteria; * Specific exclusion criteria for Cohort A (Fine Needle Biopsy): * prothrombin time (PTT) \>2x ULN * international normalized ratio (INR) \>1.5 * Platelets \<50,000/mm3 * Chronic venous stasis of lower extremities * Lower extremity lymphedema * Allergies to local anesthetic * Blood coagulation disorder. * The following laboratory abnormalities (lab tests may be repeated to obtain acceptable values before failure at screening is concluded); * Hematology: * Hemoglobin \< 14.0 g/dL for men and \<12.0 g/dL for women; * Absolute Neutrophil Count (ANC) ≤ 1,500 /mm\^3 (≤ 1 x 10\^9/L); * Platelets ≤ 150,000 /mm\^3 * Biochemistry: * Aspartate aminotransferase (AST) \> 1.25 x ULN; * Alanine aminotransferase (ALT) \> 1.25 x ULN; * Bilirubin ≥1.5 x ULN (if on atazanavir ≥5 x ULN); * Interferon-gamma release assay (IGRA) for tuberculosis (TB) with negative results within 90 days prior to study entry * Thyroid stimulating hormone (TSH) outside the normal reference range; * Free thyroxine (T4) outside the normal reference range * Presence of Anti-thyroid peroxidase (TPO) antibodies; * Presence of anti-glutamic acid decarboxylase (GAD) antibodies * Antinuclear antibody (ANA) \>1:80 at screening * Early morning (8-9 am) cortisol outside the normal reference range. Note: female participants on estrogen-containing oral contraception or other exogenous estrogen treatment may repeat the AM cortisol as part of screening to determine eligibility; * Fasting blood sugar \> 7.0 mmol/L (unless already diagnosed with Type 2 Diabetes Mellitus); * Microbiology: * Positive for hepatitis B surface antigen; * Positive for hepatitis C antibody, unless confirmed clearance of HCV infection (spontaneous or following treatment) by polymerase chain reaction (PCR) testing.

Treatments Being Tested

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.

Locations (2)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Alfred Hospital - Department of Infecious Diseases

Melbourne, Victoria, Australia

Tan Tock Seng Hospital

Singapore, Singapore

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05187429), the sponsor (University of Melbourne), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05187429 clinical trial studying?

Who can participate in NCT05187429?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05187429?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05187429. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05187429. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.