BridgeMD
New treatment option for HIV I Infection
Official title Low Dose Nivolumab in Adults Living With HIV on Antiretroviral Therapy
ClinicalTrials.gov ID: NCT05187429
What this study is testing
What is Nivolumab 10 MG/ML [Opdivo]?
Nivolumab 10 MG/ML [Opdivo] is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hiv i infection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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;
You likely can't join if
- Active, known and suspected autoimmune disease (including but not limited to including but not limited to inflammatory bowel diseases, scleroderma...
- 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...
- History of solid organ transplant. Note Individuals with prior corneal transplants may be allowed to enroll after discussion with and approval from...
See the full eligibility criteria
Who can join
- 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 \ 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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'
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Melbourne, Victoria, Australia
- Singapore, Singapore
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Melbourne, Victoria, Australia; Singapore, Singapore. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.