Experience using MedDRA for global events coding in HIV clinical trials.

Objectives: To assess the feasibility of coding with MedDRA, the Medical Dictionary for Regulatory Activities, not only serious adverse events required for notification but also all other events usually reported in HIV clinical trials. To develop an approach for MedDRA implementation within an institutional research unit that contributes to an efficient, concise and reproducible event coding. To evaluate the impact of the maintenance and the versioning of this new medical terminology.

[Good clinical practice:impediment of source of progress?].

On the bases of the Declaration of Helsinki (1964), the law called Huriet-Sérusclat (1988) and several subsequent decrees have clearly defined the appropriate organization and management of clinical trials in France. The law on the Commission de l'informatique et des libertés (1978) and several European regulations have also to be taken into account. This extensive legal and regulatory system has been the source of a major improvement in the scientific quality of clinical trials and in the security of participating persons.

Disclosure of HIV seropositivity.

Deciding whether or not to disclose one's HIV-positive status to another person is an important decision: the way each person experiences and copes with the illness is reflected in this choice. We conducted a study of 174 patients (29.3% of women) to examine how the decision to disclose or conceal was made, as well as its subjective and social consequences.

[Recommendations for the study of drug combination therapy for the treatment of AIDS and cancer. Round Table No 7 at Giens XIII].

Medicine combinations for AIDS and cancer treatment are becoming common practice in most clinical stages. These combinations are based on clinical developments which do not follow established guidelines such as those for fixed combinations. There are no current recommendations which can guide these developments and we have tried to identify the critical steps.