Clinical trials of antiretroviral drugs: the role of the MRC AIDS Therapeutic Trials Committee (ATTC) and the MRC Clinical Trials Unit (CTU).

Abstract

Since the development of the first MRC trial in 1987, the MRC AIDS Therapeutic Trials Committee (ATTC) and MRC Clinical Trials Unit (CTU have made an important contribution to the clinical trials that have led to the development of effective antiretroviral therapy (ART) regimens, which are widely used in the developed world today. ART has led to major reductions in mortality and morbidity but at considerable cost, both financial and in terms of the adverse effects and impact on quality of life which the complex life-long therapy regimens impose. The first trial of zidovudine (AZT, ZDV) demonstrated a significant reduction in mortality and morbidity in people with acquired immunodeficiency syndrome (AIDS) and advanced AIDS-related complex (ARC), and this increased the pressure on the ATTC to respond to an epidemic of a highly fatal, and until then untreatable, disease affecting young people, for which drugs were becoming available and urgent action was needed if they were to be properly investigated [1]. The increasing number of drugs that have become available have dramatically improved the prognosis of human immunodeficiency virus (HIV) infection in developed countries but without achieving eradication of the virus and cure. However, the challenges to the evaluation of new therapies have increased in parallel, and the need to identify therapeutic regimens that can be used in resource-poor countries has become more urgent, as the prices of drugs have been considerably reduced due to international pressure and ways of funding therapy are being actively pursued through initiatives such as the Global Health Fund.