Viral Infectious Diseases | Now recruiting volunteers | Current projects
NIVO-LD: Safety, immunogenicity and efficacy of low dose Nivolumab in adults living with HIV on antiretroviral therapy (ART)
Finding a cure for HIV will provide a way for individuals with HIV to stop HIV medication and keep the virus under control safely. The main reason why HIV cannot be cured at the current moment is because HIV can hide in resting long-lived cells of the immune system despite effective antiretroviral therapy (ART).
The immune responses are unable to completely clear infected cells and control the virus. During HIV infection, immune cells become exhausted, weakening the immune response. This exhaustion is caused by an increase in specific proteins in T cells that inhibit their activity. One of these proteins, known as PD-1, can be blocked with the drug Nivolumab, which boosts T cell function. Nivolumab is currently approved for use in certain cancers.
This is a two-step dose finding phase 1b trial in adults living with HIV on suppressive ART. Participants will be recruited in two cohorts.
- Cohort A will determine the appropriate dose of the investigational agent (Nivolumab). The safety profile will be examined, before the commencement of Cohort B.
- Cohort B will confirm safety and assess the immunogenicity and effect of the investigational agent during a time-limited ART interruption.
If you are interested in participating, please refer to the link below for further details about the study: https://clinicaltrials.gov/study/NCT05187429
Approved by Alfred Hospital (Study ID: 358/20)