Double-blind placebo-controlled trial of oral dehydroepiandrosterone in patients with advanced HIV disease

Objective Plasma levels of dehydroepiandrosterone sulphate (DHEA-S) decreas e with the progression of HIV disease. Here, we report on the efficacy and safety of the oral administration of DHEA as replacement therapy, in patien ts with advanced HIV disease, in a trial that was primarily aimed at assess ing quality of life. Design The trial was randomized and double-blind. Thirty-two patients were allocated to either DHEA 50 mg per day for 4 months (n=14) or a matching pl acebo (n=18). Clinical data, virological and immunological surrogate marker s of HIV infection, plasma levels of DHEA-S and the Medical Outcomes Study HIV Health Survey (MOS-HIV) quality of life scale were recorded every month . Results The mean age of the patients was 40 +/- 11 years. The mean CD4 cell count at baseline was 32.5 +/- 32.4 x 10(6)/I. The mean DHEA-S plasma leve l at baseline was 5.23 +/-0.76 mu mol/l. No side-effects related to DHEA oc curred during the study. A statistically significant increase in the levels of DHEA-S was observed in the treated group throughout the study (P<0.01). A significant improvement in the Mental Health and Health Distress dimensi on of MOS-HIV was observed in the DHEA treated group; P=0.001 and 0.004, re spectively. No change in CD4 cell counts was seen during follow-up. Conclusions The administration of DHEA in patients with advanced HIV infect ion results in Improved mental function scores as assessed by the MOS-HIV q uality of life scale.