Low Dose Nivolumab in Adults Living With HIV on Antiretroviral Therapy
ConditionHIV I Infection
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Melbourne
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Nivolumab 10 MG/ML [Opdivo]
- Nivolumab 10 MG/ML [Opdivo]
- Saline
Treatment groups
42 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov