HIV-1-infection
Conditions
Brief summary
Primary safety endpoint: defined as treatment-emerging adverse events (AEs) ≥ grade 3 probably or definitely related to study treatment., Primary efficacy endpoint: Time from ART cessation until meeting ART restart criteria defined as the day on which plasma HIV-1 RNA levels have been sustained ≥ 1,000 copies/mL for 4 consecutive weeks, the day of confirmed plasma HIV RNA levels > 100.000 copies/mL or the day of confirmed CD4+ T cell count <350 cells/uL or confirmed CD4+ T cell percentage <15%).
Detailed description
Safety defined as all other treatment-emerging AEs, graded according to severity and assessed as either not related or possibly, probably or definitely related to study treatment., Rebound viral kinetics during the analytical treatment interruption including time to time to >50 copies/mL and >1,000 copies/mL as well as doubling times (with plasma HIV-1 RNA measured using routine care clinical assays)., Proportion maintaining VL <1,000 copies/mL HIV-1 RNA at the end of ATI, Proportion of participants that have not met ART restart criteria at the end of ATI, HIV-specific CD4+ and CD8+ T cell responses by performing HIV peptide stimulation and intracellular cytokine staining (ICS) for HIV-specific T cells using flow cytometry, The frequency of peripheral blood CD4+ T cells containing total and intact HIV-DNA while on suppressive ART, The proportion of cells containing constitutive and inducible cell-associated multiply spliced HIV RNA (MS HIV-RNA) using the tat/rev induced limiting dilution assay (TILDA) while on suppressive ART, The level of cell-associated unspliced HIV RNA (CA-US HIV RNA) in peripheral blood CD4+ T cells using real-time PCR while on suppressive ART, Numbers and proportions of B cells, total lymphocytes, CD8+ T cells and CD4+ T cells including memory subsets
Interventions
DRUGPlacebo capsules
DRUGPomalidomide
Sponsors
Region Midtjylland
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary safety endpoint: defined as treatment-emerging adverse events (AEs) ≥ grade 3 probably or definitely related to study treatment., Primary efficacy endpoint: Time from ART cessation until meeting ART restart criteria defined as the day on which plasma HIV-1 RNA levels have been sustained ≥ 1,000 copies/mL for 4 consecutive weeks, the day of confirmed plasma HIV RNA levels > 100.000 copies/mL or the day of confirmed CD4+ T cell count <350 cells/uL or confirmed CD4+ T cell percentage <15%). | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety defined as all other treatment-emerging AEs, graded according to severity and assessed as either not related or possibly, probably or definitely related to study treatment., Rebound viral kinetics during the analytical treatment interruption including time to time to >50 copies/mL and >1,000 copies/mL as well as doubling times (with plasma HIV-1 RNA measured using routine care clinical assays)., Proportion maintaining VL <1,000 copies/mL HIV-1 RNA at the end of ATI, Proportion of participants that have not met ART restart criteria at the end of ATI, HIV-specific CD4+ and CD8+ T cell responses by performing HIV peptide stimulation and intracellular cytokine staining (ICS) for HIV-specific T cells using flow cytometry, The frequency of peripheral blood CD4+ T cells containing total and intact HIV-DNA while on suppressive ART, The proportion of cells containing constitutive and inducible cell-associated multiply spliced HIV RNA (MS HIV-RNA) using the tat/rev induced limiting diluti | — |
Countries
Denmark
Outcome results
None listed