Research In Viral Eradication of HIV Reservoirs

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.

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Conditions

• HIV

Interventions

DRUG

Combination Antiretroviral Therapy (cART)

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.

DRUG

Raltegravir

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.

DRUG

Vorinostat

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.

BIOLOGICAL

ChAdV63.HIVconsv (ChAd)

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.

BIOLOGICAL

MVA.HIVconsv (MVA)

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)

Sponsors & Collaborators

• Medical Research Council

  collaborator OTHER_GOV

• University of Oxford

  collaborator OTHER

• University of Cambridge

  collaborator OTHER

• Chelsea and Westminster NHS Foundation Trust

  collaborator OTHER

• Royal Free Hospital NHS Foundation Trust

  collaborator OTHER

• Brighton and Sussex University Hospitals NHS Trust

  collaborator OTHER

• Guy's and St Thomas' NHS Foundation Trust

  collaborator OTHER

• Central and North West London NHS Foundation Trust

  collaborator OTHER

• Imperial College London

  lead OTHER

Principal Investigators

• Sarah Fidler, MD · Imperial College London

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-11-27

Primary Completion

2017-11-15

Completion

2023-03-31

Countries

• United Kingdom

Study Locations