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Completed

NCT Number: NCT02961829

Multi Interventional Study Exploring HIV-1 Residual Replication: a Step Towards HIV-1 Eradication and Sterilizing Cure

It is becoming clear that a combination of interventions will be desirable to achieve HIV cure. Therefore the investigators propose a pilot proof of concept study, using combination of a number of different interventions for eradicating residual plasma viremia and decreasing HIV reservoirs. The investigators hypothesize that, (i) antiretroviral intensification using Maraviroc, and/or dolutegravir with (ii) Dendritic Cell vaccination using autologous HIV, and (iii) purging intervention using the Class III HDACs, Sirtuin-1, and (iv) decreasing the ratio of long-lived central memory (TCM)/transitional memory (TTM) CD4+ T-cells using Auranofin will provide a synergistic impact leading to a sterilizing cure of HIV infection. Results of this study may provide insightful evidence for planning the next steps using the more efficacious combination of intervention strategies towards HIV sterilizing cure.

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Key information

Conditions

Chronic Infection Disease Attributes HIV Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Persistent Infection

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

CCDI

São Paulo, 04040002, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Maraviroc

Drug

antiretroviral intensification

Other names: Selzentry, Celsentri

Dolutegravir

Drug

antiretroviral intensification

Other names: Tivicay

Dendritic cell Vaccine

Biological

Therapeutic vaccination

Other names: DC Vaccine

Auranofin

Drug

purging

Other names: Gold Salt

Sirtuin Histone deacetylase inhibitor

Drug

latency disruption

Other names: Nicotinamide

Primary outcomes

  1. Ultrasensitive RNA Viral load,

    Time frame: from baseline and every 4 weeks up to 48 weeks.

  2. Cell-associated HIV RNA

    Time frame: from baseline and every 4 weeks up to 48 weeks.

  3. Episomal DNA

    Time frame: from baseline and every 4 weeks up to 48 weeks

  4. specific HIV antibodies

    Time frame: from baseline and every 4 weeks up to 48 weeks

  5. CD38 and HLA-DR on CD4 and CD8+ cells

    Time frame: from baseline and every 4 weeks up to 48 weeks

  6. PBMC for env sequence evolution

    Time frame: from baseline and every 4 weeks up to 48 weeks

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Fundação de Amparo à Pesquisa do Estado de São Paulo
  • ViiV Healthcare

Registry information

Important dates

Study start
2015
Primary completion
2019
Study completion
2020
First posted
Nov 11, 2016
Registry last updated
Jul 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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