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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2020-03-31

Brief Summary

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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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Detailed Description

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Conditions

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Chronic Infection HIV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Antiretroviral Treated (ART) Group

Five patients will receive no further intervention this group (control group)

Group Type NO_INTERVENTION

No interventions assigned to this group

ART Intensification Group

Five patients will receive antiretroviral intensification with maraviroc and dolutegravir for 48 weeks

Group Type EXPERIMENTAL

Maraviroc

Intervention Type DRUG

antiretroviral intensification

Dolutegravir

Intervention Type DRUG

antiretroviral intensification

ART Intensification + Nicotinamide Group

Five patients will receive antiretroviral intensification with maraviroc and dolutegravir and the Sirtuin Histone deacetylase inhibitor nicotinamide for 48 weeks.

Group Type EXPERIMENTAL

Maraviroc

Intervention Type DRUG

antiretroviral intensification

Dolutegravir

Intervention Type DRUG

antiretroviral intensification

Sirtuin Histone deacetylase inhibitor

Intervention Type DRUG

latency disruption

ART Intensification + Auranofin Group

Five patients will receive antiretroviral intensification with maraviroc and dolutegravir for 48 weeks and the gold salt auranofin for 24 weeks.

Group Type EXPERIMENTAL

Maraviroc

Intervention Type DRUG

antiretroviral intensification

Dolutegravir

Intervention Type DRUG

antiretroviral intensification

Auranofin

Intervention Type DRUG

purging

ART Intensification + DC vaccine Group

Five patients will receive antiretroviral intensification with dolutegravir and for 48 weeks, and dendritic cell vaccine.

Group Type EXPERIMENTAL

Dolutegravir

Intervention Type DRUG

antiretroviral intensification

Dendritic Cell Vaccine

Intervention Type BIOLOGICAL

Therapeutic vaccination

Multi Interventional Group

Five patients will receive antiretroviral intensification with dolutegravir and the Sirtuin Histone deacetylase inhibitor nicotinamide for 48 weeks, and gold salt for 24 weeks and dendritic cell vaccine.

Group Type EXPERIMENTAL

Dolutegravir

Intervention Type DRUG

antiretroviral intensification

Dendritic Cell Vaccine

Intervention Type BIOLOGICAL

Therapeutic vaccination

Auranofin

Intervention Type DRUG

purging

Sirtuin Histone deacetylase inhibitor

Intervention Type DRUG

latency disruption

Interventions

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Maraviroc

antiretroviral intensification

Intervention Type DRUG

Dolutegravir

antiretroviral intensification

Intervention Type DRUG

Dendritic Cell Vaccine

Therapeutic vaccination

Intervention Type BIOLOGICAL

Auranofin

purging

Intervention Type DRUG

Sirtuin Histone deacetylase inhibitor

latency disruption

Intervention Type DRUG

Other Intervention Names

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Selzentry Celsentri Tivicay DC Vaccine Gold Salt Nicotinamide

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No