Last updated 30 days ago

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

70 patients around the world

Available in Brazil

Federal University of São Paulo

70Patients around the world

This study is for people with

Hiv

Requirements for the patient

To 65 Years

All Gender

Medical requirements

: > 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.

: 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.

SponsorFederal University of São Paulo

Study typeInterventional

Conditions

Hiv

Requirements

To 65 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT06805656