NCT07903441RecruitingPhase 2
Multiple Interventions With Distinct Anti-reservoir Activities in People on Antiretroviral Treatment
Phase 2b Clinical Trial Using Multiple Interventions With Distinct Anti-Reservoir Activities In People On Antiretroviral Treatment
Source: ClinicalTrials.gov · Last updated 29 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- First submitted
- 28 May 2026
- Start date
- 1 Aug 2026
- Primary completion date
- 31 Jul 2027
- Lead sponsor
- Federal University of São Paulo
- Diseases
- HIV
- NCT number
- NCT07903441
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 70
- From 1 Aug 2026 to the primary completion date, 31 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Known hypersensitivity to the components of gold salt, nicotinamide or its analogs.
- Any condition which, in the investigators opinion, could compromise the subject's safety or adherence to the trial protocol.
Lab values
- 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.
- 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.
Other
- A subject will NOT be eligible for study participation if he/she meets ANY of the following criteria:
Who the study is looking for
- \> 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.
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Laboratório de Retrovirologia, UNIFESP Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.