[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. The main difficulty is to balance the fast development required by the poor prognosis of these diseases and the protection of patients who can only be subjected to combinations for which reasonable expectation of a favourable therapeutic index is foreseen. For each pathology, the pre-clinical evidence-needed before pilot clinical studies and the surrogate clinical end-points are considered (viral load for AIDS and response rate for cancer). These are prerequisities for randomized clinical trials, which are the only means of definitive assessment of new combinations versus existing therapies.