Pomalidomide As an Immune-enhancing Agent for the Control of HIV
Phase 1
Not yet recruiting
- Conditions
- HIV-1 Infection
- Interventions
- Registration Number
- NCT06660498
- Lead Sponsor
- University of Aarhus
- Brief Summary
This study is designed to evaluate the safety and efficacy of pomalidomide in HIV-1-infected individuals on ART and to determine the impact of pomalidomide on virological control in people living with HIV during an analytical treatment interruption.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 32
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pomalidomide Pomalidomide 2 mg This arm will receive pomalidomide 2 mg oral capsules Pomalidomide Aspirin 75 mg This arm will receive pomalidomide 2 mg oral capsules Placebo Placebo This arm will receive placebo (oral capsules with no active drug) Placebo Aspirin 75 mg This arm will receive placebo (oral capsules with no active drug)
- Primary Outcome Measures
Name Time Method Efficacy of treatment, measured as the time from ART cessation until meeting ART restart criteria. From ATI to the end of treatment at visit 18 or 16 weeks after meeting ART restart criteria Safety of treatment, measured by the number of treatment-emergent adverse events (AEs) of grade 3 or higher that are probably or definitely related to the study treatment. From enrollment to the end of treatment at visit 18 or 16 weeks after meeting ART restart criteria
- Secondary Outcome Measures
Name Time Method Safety, defined as all other treatment-emerging adverse events (AEs) From enrollment to the end of treatment at visit 18 or 16 weeks after meeting ART restart criteria AEs are graded according to severity and assessed as either not related or possibly, probably or definitely related to study treatment.
Rebound viral kinetics during the ATI, including plasma HIV-1 RNA copies/mL doubling times From ATI to the end of treatment at visit 18 or 16 weeks after meeting ART restart criteria The proportion of participants maintaining HIV-1 RNA levels below 1,000 copies/mL at the end of the ATI. From ATI to the end of treatment at visit 18 or 16 weeks after meeting ART restart criteria The proportion of participants who have not met ART restart criteria at the end of the ATI. From ATI to the end of treatment at visit 18 or 16 weeks after meeting ART restart criteria The frequency of peripheral blood CD4+ T cells containing total and intact HIV-DNA while on suppressive ART From enrollment to the end of treatment at visit 18 or 16 weeks after meeting ART restart criteria HIV-specific CD4+ responses From enrollment to the end of treatment at visit 18 or 16 weeks after meeting ART restart criteria HIV-specific CD8+ T cell responses From enrollment to the end of treatment at visit 18 or 16 weeks after meeting ART restart criteria The proportion of cells containing constitutive and inducible MS HIV-RNA From enrollment to the end of treatment at visit 18 or 16 weeks after meeting ART restart criteria The level of CA-US HIV RNA in peripheral blood CD4+ T cells From enrollment to the end of treatment at visit 18 or 16 weeks after meeting ART restart criteria Numbers of B cells, total lymphocytes, CD8+ T cells and CD4+ T cells including memory subsets From enrollment to the end of treatment at visit 18 or 16 weeks after meeting ART restart criteria Proportions of B cells, total lymphocytes, CD8+ T cells and CD4+ T cells including memory subsets From enrollment to the end of treatment at visit 18 or 16 weeks after meeting ART restart criteria
Trial Locations
- Locations (2)
Royal Melbourne Hospital
🇦🇺Melbourne, Australia
Aarhus University Hospital
🇩🇰Aarhus, Denmark