Double-blind placebo-controlled trial of oral dehydroepiandrosterone in patients with advanced HIV disease.
OBJECTIVE
Plasma levels of dehydroepiandrosterone sulphate (DHEA-S) decrease with the progression of HIV disease. Here, we report on the efficacy and safety of the oral administration of DHEA as replacement therapy, in patients with advanced HIV disease, in a trial that was primarily aimed at assessing quality of life.


METHODS
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 placebo (n = 18). Clinical data, virological and immunological surrogate markers 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)/l. The mean DHEA-S plasma level at baseline was 5.23 +/- 0.76 micromol/l. No side-effects related to DHEA occurred 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 dimension of MOS-HIV was observed in the DHEA treated group; P = 0.001 and 0.004, respectively. No change in CD4 cell counts was seen during follow-up.


CONCLUSIONS
The administration of DHEA in patients with advanced HIV infection results in improved mental function scores as assessed by the MOS-HIV quality of life scale.
Piketty
C
C
Unité d'Immunologie Clinique and Université Pierre et Marie Curie, Hôpital Européen Georges Pompidou, Paris, France. piketty@egp.ap-hop-paris.fr
Jayle
D
D
Leplege
A
A
Castiel
P
P
Ecosse
E
E
Gonzalez-Canali
G
G
Sabatier
B
B
Boulle
N
N
Debuire
B
B
Le Bouc
Y
Y
Baulieu
E E
EE
Kazatchkine
M D
MD
D000328:Adult; D019314:Dehydroepiandrosterone Sulfate / Q000097:blood* / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D015658:HIV Infections / Q000097:blood* / Q000523:psychology; D015497:HIV-1; D006305:Health Status Indicators; D020249:Hormone Replacement Therapy; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011594:Psychometrics; D011788:Quality of Life
D019314:Dehydroepiandrosterone Sulfate