Pomalidomide as an immune-enhancing agent for the control of HIV (PEACH)

Trial details

Who runs it

Region Midtjylland

Trial code

EU 2024-512797-10-00

Record updated

2026. július 24.

Original description

To determine the impact of pomalidomide on HIV-specific CD8+ T cell function in people living with HIV (PLWH) of ART.Read full original descriptionShow less

Pomalidomide as an immune-enhancing agent for the control of HIV (PEACH): An investigator-initiated phase I/IIb clinical trial in people living with HIV on ART and during analytical treatment interruption.

To determine the impact of pomalidomide on HIV-specific CD8+ T cell function in people living with HIV (PLWH) of ART.

Inclusion: Documented HIV-1 infection; Receiving combination ART for at least 1 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 >1 year (documented on at least 2 occasions within the 1 years and <20 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 count >500 cells/μL at screening and at least two CD4+ T cell counts >350 cells/μL in the 24 months prior to screening; Ability and willingness to provide informed consent and to continue ART throughout the study; All participants must agree to avoid conception and undergo a strict set of criteria to avoid female participants becoming pregnant and male participants impregnating others.

Exclusion: Currently receiving anticoagulant therapy; Currently receiving other systemic immune-enhancing or immunosuppressive therapy (immunisation and locally applied agents are allowed) or having received any of those within 28 days prior to study entry; Received peg- IFNα treatment within 12 months; Co-infection with Hepatitis B, hepatitis C or D (Individuals with prior hepatitis C infection that is now cleared are eligible for enrolment); Current (within the previous two weeks) use of strong CYP1A2 inhibitors (e.g. ciprofloxacin and fluvoxamine) at enrolment; Current or recent gastrointestinal disease or gastrointestinal surgery that may impact the absorption of the investigational drug; Prior or current lenalidomide, thalidomide or pomalidomide treatment or any condition where those treatments are indicated; Active alcohol or substance use that, in the Investigator's opinion, will prevent adequate compliance with study therapy or procedures; Known allergy or hypersensitivity to pomalidomide or its analogues; History of procoagulant disorders or venous/arterial thromboembolism; History of malignancy or transplantation, excluding adequately treated basal cell carcinoma; Any evidence of an active AIDS-defining opportunistic infection; Significant cardiac dysfunction; Laboratory values at screening: hepatic transaminases (AST or ALT) ≥3 x upper limit of normal (ULN), eGFR <50 mL/min, platelet count ≤100 x10^9/L, absolute neutrophil count ≤1.5x10^9/L, haemoglobin <10,0 g/dL, total lymphocyte count <800 cells/μL, CD4+ T cell count <500 cells/μL; Hepatic impairment defined as ALT >3 x upper limit of normal or Child-Pugh class C; Impaired renal function with estimated creatinine clearance (eGFR) <50 mL/min; Regular NSAID usage (>7 days continuous use in the last month) and/or unable to avoid regular NSAID use on the trial; Women who are pregnant or breastfeeding or Women of Child Bearing Potential (WOCBP) who are unwilling or unable to use an acceptable method of contraception to avoid pregnancy as specified in the inclusion criteria; Unable or unwilling to adhere to protocol procedures.

EU CTIS 2024-512797-10-00