Strategies to reduce HIV reservoirs to help remission without daily meds

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 trial combines multiple interventions intended to reduce HIV reservoirs in adults on suppressive ART. Participants receive a regimen that includes intensified ART, a histone deacetylase inhibitor to disrupt latent virus, an anti-proliferative agent to target long-lived HIV-harboring cells, and a personalized dendritic cell vaccine. The goal is to lower residual viral reservoirs and immune activation to enable long-term remission off antiretrovirals. The study builds on encouraging exploratory results and expands enrollment to evaluate safety and preliminary efficacy of the multimodal approach.

Why it matters

Who can join: the full rules

Inclusion Criteria:

\- \> 18 years old \< 65 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:

\- 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 (colonystimulating 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.

Where it's running

• Ccdi
  São Paulo, São Paulo, Brazil Recruiting

Study contacts

• Study coordinator: Ricardo S Diaz, M.D.; PhD
• Email: rsdiaz@catg.com.br
• Phone: +55 11 991090445

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.