About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Maraviroc
Drugantiretroviral intensification
Dolutegravir
Drugantiretroviral intensification
Dendritic Cell Vaccine
Biological/Vaccinetherapeutic vaccination
Auranofin
Drugpurging
Sirtuin Histone deacetylase inhibitor
Druglatency disruption
Treatment groups
Trial outcomes
Primary outcomes
Evolution of viral load of HIV RNA over the time frame of study
Viral load count by qPCR at each time point to measure the viral persistence in each participant
Evolution of total DNA and episomal HIV in PBMCs
Quantification of total DNA and episomal HIV in a virological assay
Evolution of cell-associated HIV RNA in PBMCs over the study time frame
Quantification of HIV RNA in PBMCs by qPCR
Evolution of total DNA and episomal HIV DNA in lymphoid tissue (rectal biopsy)
Quantification by in-house virological assay
Sponsors and contacts
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Federal University of São Paulo
Lead sponsor
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Collaborator
Weill Medical College of Cornell University
Collaborator
Fundação de Amparo à Pesquisa do Estado de São Paulo
Collaborator