By Mark Harrington

December 1993

From the Introduction

In November 1989, AIDS activists attended our first AIDS Clinical Trials Group (ACTG) meeting. We were not given a warm welcome. After many months of struggle, activists and people with HIV were integrated into the ACTG system and given voting representation on each committee, and many ACTG sessions were opened up to community observers.

Four years after those events, however, many of the initial criticisms of ACTG research remain relevant. Moreover, new problems have emerged which demand changes in the design, conduct and analysis of clinical trials for AIDS and HIV-related conditions. In addition, hard-won victories by activists (e.g., parallel track, active-controlled studies, accelerated approval) have produced a new set of issues of their own which must be addressed. Finally, results of recent, relatively large-scale clinical trials have been disappointing; despite substantial aggregate improvements in quality and length of life since the mid1980s, the hoped-for long-term benefits of early or combination intervention with antiretroviral therapies have not materialized.

Those designing the latest batch of clinical trials have tended to ignore these setbacks, proceeding as though nothing was wrong with the assumptions, some of which are now undermined by the data, underlying these studies. This report is an effort to critically assess the current impasse.