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

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 months later Jan 1, 2027 → Mar 1, 2027
See other at-risk trials from Federal University of São Paulo

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor 2 versions Re-verified since Aug 11, 2026, no change to tracked fieldsv5-v6
  2. Notable Recruitment openedv4 Show 6 more changesShow less
    • Primary completion pushed from Jan 1, 2027 to Mar 1, 2027
    • Study completion pushed from Dec 31, 2027 to Jun 1, 2028
    • Start date: Jul 1, 2026 to Jul 15, 2026
    • Site details revised
    • Collaborators: 1 to 3
    • Study title revised
  3. Notable Primary completion date: Jul 1, 2026 to Jan 1, 2027
    • Start date: Sep 1, 2025 to Jul 1, 2026
    v3
  4. Notable Phase: Not applicable to Phase 2
    • Start date: Apr 1, 2025 to Sep 1, 2025
    v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
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
(from sponsor)
Hiv, HIV I Infection
Related terms Acquired Immunodeficiency Syndrome
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov