Safety, Immunogenicity and Efficacy of Low Dose Nivolumab in Adults Living With HIV on Antiretroviral Therapy (ART)

Who is this study for? People living with HIV
What treatments are being studied? Nivolumab
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
Australia
Alfred Hospital - Department of Infecious Diseases
RECRUITING
Melbourne
Singapore
Tan Tock Seng Hospital
NOT_YET_RECRUITING
Singapore
Contact Information
Primary
Barbara Scher
barbara.scher@unimelb.edu.au
+61 (0)3 8344 0770
Time Frame
Start Date: 2023-01-24
Estimated Completion Date: 2026-01
Participants
Target number of participants: 42
Treatments
Experimental: Dose escalation phase (Cohort A)
Drug: Nivolumab Dose form: infusion Dose route: intravenous Dosage: 0.1, 0.3 or 1.0 mg/kg Duration: Single dose administered on Study Day 7
Experimental: Randomization phase (Cohort B)
Drug: Nivolumab Dose form: infusion Dose route: intravenous Dosage: determined from Cohort 1 Duration: single dose administered on Day 0 (baseline)
Placebo_comparator: Randomization phase comparator (Cohort B)
Comparator: saline Dose form: infusion Dose route: intravenous Duration: single dose administered on Day 0 (baseline)
Related Therapeutic Areas
Sponsors
Leads: University of Melbourne
Collaborators: The Alfred

This content was sourced from clinicaltrials.gov