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NOT YET RECRUITING
NCT06805656
PHASE2

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

Sponsor: Federal University of São Paulo

View on ClinicalTrials.gov

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 patient 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.

Official title: Multi Interventional Approaches to Mitigate HIV Reservoirs Aiming the Sustained HIV Remission Without Use of Antiretrovirals

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2025-09-01

Completion Date

2027-12-31

Last Updated

2025-08-11

Healthy Volunteers

No

Interventions

DRUG

Maraviroc

antiretroviral intensification

DRUG

Dolutegravir

antiretroviral intensification

BIOLOGICAL

Dendritic Cell Vaccine

therapeutic vaccination

DRUG

Auranofin

purging

DRUG

Sirtuin Histone deacetylase inhibitor

latency disruption

Locations (1)

CCDI

São Paulo, São Paulo, Brazil