Clinical Trial

Multi Interventional Approaches to Mitigate HIV Reservoirs for the Sustained HIV Remission Without Antiretrovirals

Recruiting Phase 2
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Summary
A modern and urgent challenge in fighting HIV infection is to achieve sustained HIV remission without the use of antiretrovirals. The investigators' preliminary data indicate that the use of combined strategies to mitigate the HIV proviral reservoir size among individuals with suppressive antiretroviral treatment achieved unprecedented results in the reduction of HIV DNA present in these cells and in the reduction of CD4 + and CD8 + T cell activation. Combined interventions include intensified antiretroviral treatment to mitigate residual HIV replication, use of a histone deacetylase inhibitor to interrupt viral latency, use of an anti-proliferative medication to reduce long-lived T cells that harbor HIV and a personalized dendritic cell therapy vaccine to eliminate cells with latent HIV infection or cells present in viral sanctuaries. Due to the good results obtained in the exploratory stage of the project, the investigators propose to expand it by recruiting a larger number of patients to confirm the previously obtained results and to generate new insights related to the mechanisms involved in viral latency, latency disruption and the effects of analytical treatment interruption of antiretrovirals among patients undergoing all above mentioned interventions.
Protocol Amendment History 3 changes
critical Recruitment opened 2026-08-11
notable Primary completion pushed: 2027-01-01 -> 2027-03-01 2026-08-11
minor Completion pushed: 2027-12-31 -> 2028-06-01 2026-08-11
Trial Details
NCT Number NCT06805656
Lead Sponsor Federal University of São Paulo
Collaborators: Conselho Nacional de Desenvolvimento Científico e Tecnológico, Weill Medical College of Cornell University, Fundação de Amparo à Pesquisa do Estado de São Paulo
Conditions Hiv, HIV I Infection
Enrollment 70 participants
Start Date 2026-07-15
Primary Completion 2027-03-01 (estimated)
Study Completion 2028-06-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-13