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RECRUITING

NCT07903441

PHASE2

Multiple Interventions With Distinct Anti-reservoir Activities in People on Antiretroviral Treatment

Sponsor: Federal University of São Paulo

View on ClinicalTrials.gov

Summary

Contemporary ART fails to eradicate the HIV-1 virus from PWH, resulting in a rebound in viremia within days to weeks after cessation of ART. Evidence indicates that disparities in biological and sociocultural characteristics between resource-limited and resource-privileged settings affect treatment outcomes. Consequently, resource-constrained settings must possess the capability to comprehend the mechanisms and drivers of HIV persistence, as well as to devise and evaluate therapies for HIV cure or prolonged remission within local populations. The investigators will employ genomic, metabolomics, and transcriptomics to analyze samples from a successful therapeutic trial we conducted in Brazil, a resource-constrained country, to identify and investigate mechanisms of HIV persistence and we will employ novel latency-reversal agents and advanced in vivo cell therapy. The clinical trial the investigators will conduct will employ a multifaceted intervention strategy to achieve HIV remission through intensified ART to reduce residual HIV replication, a novel combination of latency reversal agents (LRA), and cell therapy utilizing autologous dendritic cells infused with autologous HIV peptides.

Official title: Phase 2b Clinical Trial Using Multiple Interventions With Distinct Anti-Reservoir Activities In People On Antiretroviral Treatment

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-08-01

Completion Date

2027-12-31

Last Updated

2026-10-29

Healthy Volunteers

Conditions

HIV - Human Immunodeficiency Virus

Interventions

DRUG

Multiple therapeutic interventions

intensified antiretroviral treatment using 2 NRTIs, dolutegravir, boosted darunavir/r, and maraviroc or Leronlimab, (ii) use of the HDACi nicotinamide Riboside or nicotinamide, and dendritic cell therapy using peptides of autologous HIV. After the intervention, participants will undergo analytical treatment interruption of antiretrovirals (ATI) and will be closely followed to monitor rebound of HIV viremia.

Inclusion Criteria: \> 18 years old Documented HIV-1 infection. Has voluntarily signed ICF. On HAART ≥ 2 years, without changes in the 24 weeks immediately prior to screening. HIV viral load \<50 copies/mL, and never \> 50 copies/mL on 2 consecutive occasions in the last 2 years. CD4 count nadir. \> 350 cells/ mm3 Current CD4 count \> 500 cells/ mm3. R5 HIV-1 at Screening as defined by proviral DNA genotropism. Exclusion Criteria: A subject will NOT be eligible for study participation if he/she meets ANY of the following criteria: Any evidence of an active AIDS-defining condition. Any significant acute medical illness in the past 8 weeks. Women who are pregnant or breastfeeding. Use of any of the following within 90 days prior to entry: systemic cytotoxic chemotherapy; investigational agents; immunomodulators (colony-stimulating factors, growth factors, systemic corticosteroids, HIV vaccines, immune globulin, interleukins, interferons); coumadin, warfarin, or other Coumadin derivative anticoagulants. Use of an agent definitely or possibly associated with effects on QT intervals: amiodarone, arsenic trioxide, astemizole, bepridil, chloroquine, chlorpromazine, cisapride, clarithromycin, disopyramide, dofetilide, domperidone, droperidol, erythromycin, halofantrine, haloperidol, ibutilide, levomethadyl, mesoridazine, methadone, pentamidine, pimozide, probucol, procainamide, quinidine, sotalol, sparfloxacin, terfenadine, thioridazine. Receipt of compounds with HDAC inhibitor-like activity, such as valproic acid or nicotinamide within the last 30 days. Potential participants may enroll after a 30-day washout period. Known hypersensitivity to the components of gold salt, nicotinamide or its analogs. Hepatitis B (HBsAg +) or Hepatitis C (HCV RNA +) infection. Known renal insufficiency defined as calculated creatinine clearance (Cockcroft Gault formula) \<60 mL/min. Subjects with a laboratory abnormality grade 3 or 4 with the following exceptions: pancreatic amylase, cholesterol, triglyceride, gamma glutamyl transpeptidase, bilirubin. Any condition which, in the investigators opinion, could compromise the subject's safety or adherence to the trial protocol.

Locations (1)

Laboratório de Retrovirologia, UNIFESP

São Paulo, São Paulo, Brazil