Participants in HIV clinical trials in Europe

In recent years an increasing number of antiretrovirals have become availab le. In order to define the optimal treatment regimens an increasing number of clinical trials are needed. Our objective was to study the profile of participants in HIV clinical tria ls in Europe and learn from their experience and views. Between August 1996 and September 1997, self-administered anonymous questionnaires were distri buted to people with HIV infection at inpatient and outpatient clinics in 1 1 European countries. One thousand three hundred and sixty-six people compl eted the questionnaire (50% response rate). Four hundred and twenty (31%) o f the respondents reported that they had previously participated in at leas t one HIV clinical trial. The percentage of people who had taken part in a clinical trial varied widely between the different centres, from 12% in Ath ens to 61% in Antwerp and Brussels. A significantly higher participation ra te was observed in the northern and central part of Europe compared with th e south (respectively 40% vs 18%) and also among people with a higher incom e. Most people (92%) stated that they were 'well' or 'very well' informed p rior to enrolment in the trial. However, 4% reported that they had not give n written approval and 22% felt that they were pushed into participating. O nly 21% stated that they were informed about the outcome of the study on it s completion. The most important reason for non-participation (37% of the n on-participants) was because a clinical trial had never been proposed. In c onclusion, a majority of people with HIV infection in European HIV treatmen t reference centres were willing to participate in clinical trials. HIV cli nical trials in Europe should adhere more strictly to universal ethical sta ndards.