Pharmaceutical companies are to fund four major studies of metabolic and body fat changes following a series of meetings at the request of the European Agency for the Evaluation of Medicinal Products and its scientific advisory committee.
The studies will look at:
15,000 individuals in the EuroSIDA cohort for signs of increased risk of cardiovascular disease in people on HAART. Follow-up will last for two years. Variations in metabolic and body fat changes according to regimen in four major studies of initial regimens and treatment sequencing (ACTG 364, Initio, First and Atlantic). Follow-up will last for at least four years. Analysis of the Veteran's Administration database for signs of increased risk of cardiovascular disease A controlled study of individuals matched for age and other demographics to try to establish a case definition of lipodystrophy based on longitudinal observation rather than retrospective report. Follow-up is likely to last at least eighteen months.However, there will be no research to investigate the causes or the treatment of lipodystrophy.
The studies came about as a consequence of a request to industry from the CPMP's Pharmacovigilance Working Party for proposals on how to monitor the long-term consequences of metabolic and body fat changes on HAART. Proposals were developed by representatives of all pharmaceutical companies with licensed anti-HIV drugs, together with academics and clinicians from Europe, Australia and the USA. Community representatives, including the European AIDS Treatment Group, were also involved in the process.