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

Launched by FEDERAL UNIVERSITY OF SÃO PAULO · Jan 28, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring new ways to help people with HIV achieve long-lasting remission without relying on daily antiretroviral medications. Researchers have found promising results using a combination of strategies that target the cells where the virus hides in the body. These strategies include enhancing current HIV treatments, using special medications to wake up dormant virus, and a personalized vaccine to help the immune system eliminate infected cells. The goal is to recruit more participants to confirm these early findings and learn more about how HIV can remain hidden and how we might disrupt that.

To be eligible for this trial, participants must be between 18 and 65 years old, have a documented HIV-1 infection, and have been on effective antiretroviral therapy for at least two years without any significant changes in their treatment in the last six months. Participants also need to have a low level of HIV in their blood and a healthy immune system. Those who are pregnant, breastfeeding, or have other serious health issues may not qualify. If you join the trial, you can expect to receive close monitoring and possibly new treatment options that could lead to a better understanding of managing HIV.

Gender

ALL

Eligibility criteria

• 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.