Oxandrolone in the treatment of HIV-associated weight loss in men: a randomized, double-blind, placebo-controlled study.
OBJECTIVE
To evaluate the efficacy and safety of oxandrolone in promoting body weight and body cell mass (BCM) gain in HIV-associated weight loss.


METHODS
Randomized, double-blind, placebo-controlled trial. Two hundred sixty-two HIV-infected men with documented 10% to 20% weight loss or body mass index < or =20 kg/m were randomized to placebo or to 20, 40, or 80 mg of oxandrolone daily. After 12 weeks, subjects were allowed to receive open-label oxandrolone at a dose of 20 mg for another 12 weeks.


RESULTS
Body weight increased in all groups, including the group receiving placebo, during the double-blind phase (1.1 +/- 2.7, 1.8 +/- 3.9, 2.8 +/- 3.3, and 2.3 +/- 2.9 kg in placebo and 20-, 40-, and 80-mg oxandrolone groups, respectively; all P < 0.014 vs. baseline). BCM increased from baseline in all groups (0.45 +/- 1.7, 0.91 +/- 2.2, 1.5 +/- 2.5, and 1.8 +/- 1.8 kg in placebo and 20-, 40-, and 80-mg oxandrolone groups, respectively). At 12 weeks, only the gain in weight at the 40-mg dose of oxandrolone and the gain in BCM at the 40- and 80-mg doses of oxandrolone were greater than those in the placebo group, however. Oxandrolone treatment was associated with significant suppression of sex hormone-binding globulin, luteinizing hormone, follicle-stimulating hormone, and total and free testosterone levels. Treatment was generally well tolerated but accompanied by significant increases in transaminases and low-density lipoprotein as well as decreases in high-density lipoprotein.


CONCLUSIONS
Oxandrolone administration is effective in promoting dose-dependent gains in body weight and BCM in HIV-infected men with weight loss.
Grunfeld
Carl
C
University of California-San Francisco, and Department of Veterans Affairs Medical Center, 4150 Clement Street, San Francisco, CA 94121, USA. grunfld@itsa.ucsf.edu
Kotler
Donald P
DP
Dobs
Adrian
A
Glesby
Marshall
M
Bhasin
Shalender
S
D000328:Adult; D045930:Anabolic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D015992:Body Mass Index; D004311:Double-Blind Method; D005640:Follicle Stimulating Hormone / Q000097:blood; D015658:HIV Infections / Q000150:complications* / Q000503:physiopathology; D006801:Humans; D008075:Lipoproteins, HDL / Q000097:blood; D007986:Luteinizing Hormone / Q000097:blood; D008297:Male; D008875:Middle Aged; D010074:Oxandrolone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D010919:Placebos; D012738:Sex Hormone-Binding Globulin / Q000032:analysis; D013739:Testosterone / Q000097:blood; D000637:Transaminases / Q000097:blood; D015431:Weight Loss
D045930:Anabolic Agents; D008075:Lipoproteins, HDL; D010919:Placebos; D012738:Sex Hormone-Binding Globulin; D013739:Testosterone; D010074:Oxandrolone; D007986:Luteinizing Hormone; D005640:Follicle Stimulating Hormone; D000637:Transaminases