Can a cancer drug help flush out hidden HIV?
NCT ID NCT05187429
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is testing whether a single low dose of nivolumab, a drug used in cancer immunotherapy, can reduce the latent HIV reservoir in people living with HIV who are on antiretroviral therapy (ART). The latent reservoir is a group of dormant HIV-infected cells that current treatments cannot eliminate, forcing lifelong ART. The trial enrolls 42 adults with well-controlled HIV and will first test safety, then randomly assign some participants to receive nivolumab or a placebo to measure effects on the reservoir.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- nivolumab (Opdivo)
- What this could lead to
- If successful, this could point toward a way to reduce the hidden HIV reservoir, potentially allowing people with HIV to stop antiretroviral therapy without the virus rebounding.
- What could go wrong
- This is an early Phase 1/2 trial with only 42 participants, so results are preliminary. Nivolumab can cause immune-related side effects, and it is unknown if a single low dose will have any lasting effect on the reservoir.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 42 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2023
- Expected to finish
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Jan 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Alfred Hospital - Department of Infecious Diseases
RECRUITINGMelbourne, Victoria, 3181, Australia
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Tan Tock Seng Hospital
RECRUITINGSingapore, 308433, Singapore
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