CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 60 enrolled
Drug / intervention
Combination Antiretroviral Therapy (cART) +4 moredrug
Likely dose
Vorinostat 100mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02336074
NCT02336074Phase 2Completed
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Research In Viral Eradication of HIV Reservoirs

Imperial College London·interventional·Posted Jan 12, 2015·Updated Oct 23, 2023

In Brief

A Phase 2 clinical trial evaluating Combination Antiretroviral Therapy (cART), Raltegravir, and 3 other interventions for HIV. Completed, enrolled 60 participants across 6 sites.

Detailed Summary

This study will be a two-arm prospective 1:1 randomised controlled trial comparing: Arm A: cART preferably including raltegravir (combination ART cART - control) Arm B: cART preferably including raltegravir (cART) plus ChAdV63.HIVconsv (ChAd) prime and MVA.HIVconsv (MVA) boost vaccines; followed by a 28-day course of vorinostat (10 doses in total). We hypothesise that this intervention in primary HIV infection will confer a significant reduction in the latent HIV reservoir when compared with cART alone. .

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV
CountriesUnited Kingdom
CollaboratorsMedical Research Council, University of Oxford, University of Cambridge, Chelsea and Westminster NHS Foundation Trust, Royal Free Hospital NHS Foundation Trust, Brighton and Sussex University Hospitals NHS Trust, Guy's and St Thomas' NHS Foundation Trust, Central and North West London NHS Foundation Trust

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 12, 2015
Enrollment StartNov 27, 2015
Primary CompletionNov 15, 2017
Study CompletionMar 31, 2023
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 11.5 years ago

Interventions

Combination Antiretroviral Therapy (cART)drug

Likely consisting of an Nucleoside reverse-transcriptase inhibitor (NRTI) backbone i.e. Truvada plus a ritonavir-boosted protease inhibitor (PI) e.g. Darunavir + ritonavir. Prescribed at week 0 for the duration of the study.

Raltegravirdrug

All participants will be dispensed sufficient supplies of Raltegravir to ensure they have sufficient medication to last to the next study visit. Raltegravir is supplied in marketed pack with 30 tablets per bottle.

Vorinostatdrug

Vorinostat (suberoylanilide hydroxamic acid abbreviated to SAHA) inhibits the histone deacetylases HDAC1, HDAC2, HDAC3 (Class I) and HDAC6 (Class II). Vorinostat is supplied as capsules containing 100mg vorinostat and the following inactive ingredients: microcrystalline cellulose, sodium croscarmellose and magnesium stearate.

ChAdV63.HIVconsv (ChAd)biological

Dosage: 5x1010vp .This dose is obtained by injecting 0.37ml of the vaccine at 1.35x1011vp/ml without dilution. This prime vaccination is administered intramuscularly (IM) into the deltoid muscle of the non-dominant arm at post-randomisation week 00.

MVA.HIVconsv (MVA)biological

Dosage: 2x108pfu Administration: This dose is obtained by injecting 0.23 ml of the vaccine IM at 8.6x108pfu/ml without dilution. This boost vaccination is administered intramuscularly (IM) into the deltoid muscle of the non-dominant arm at post-randomisation week 08 Day 1 (2 prior to start of vorinostat)