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.