HIV-positive people and their advocates must be involved in all aspects of their medical care. This includes design and management of clinical trials.

Clinical trials and other research with community representation organised by UK-CAB

For full information follow the link to the ISRCTN register entry.

PIVOT

Protease Inhibitor monotherapy Versus Ongoing Triple-therapy in the long-term management of HIV infection

ISRCTN register entry: ISRCTN04857074

This trial aims to determine whether a strategy of switching to boosted protease inhibitor (PI) monotherapy is non-inferior to continuing triple drug therapy for people who have achieved sustained virological suppression on combination therapy, in terms of the proportion of patients who maintain all their available drug treatment options after at least 3 years of follow-up, and to compare clinical events, safety, toxicity and health economic parameters between the two strategies.

Parallel group, open-label, multi-centre, randomised controlled trial.

Ethics approval received from the Cambridgeshire 4 Research Ethics Committee on 28 April 2008 (ref: 08/H0305/14).

Funder: NIHR Health Technology Assessment Programme
Sponsor: Medical Research Council
Contact: Dr Nick Paton, MRC Clinical Trials Unit
Community representation: Ben Cromarty (UK-CAB) - Trial Steering Committe, Robert James (UK-CAB) - Data Safety Monitoring Board.

HCQ-01

HydroxyChloroQuine study

ISRCTN register entry: ISRCTN30019040

This study aims to determine whether hydroxychloroquine decreases immune activation in HIV, measured by least a 25% reduction in CD8 T-cell activation after 48 weeks of treatment. The study also intends to examine the effects of hydroxychloroquine on viral load and CD4 T-cell count at week 48, and to assess safety of hydroxychloroquine in this patient population.

A phase II, multi-centre, randomised, double-blind, placebo-controlled clinical trial.

Ethics approval received from the Oxfordshire REC A on the 6th March 2008.

Funder: The Wellcome Trust
Sponsor: Medical Research Council Clinical Trials Unit
Contact: Dr Nick Paton, MRC Clinical Trials Unit
Community representation: Toju Cline-Cole (UK-CAB) - Trial Steering Committee

Updated: 12 August 2008