Oxandrolone in the treatment of HIV-associated weight loss in men: a randomized, double-blind, placebo-controlled study.

Abstract

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.

CONCLUSION:

Oxandrolone administration is effective in promoting dose-dependent gains in body weight and BCM in HIV-infected men with weight loss.

• Authors: Carl Grunfeld, Donald P Kotler, Adrian Dobs, Marshall Glesby, Shalender Bhasin
• Journal: Journal of acquired immune deficiency syndromes (1999) (J Acquir Immune Defic Syndr) Vol. 41 Issue 3 Pg. 304-14 (Mar 2006) ISSN: 1525-4135 [Print] United States
• PMID: 16540931 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anabolic Agents
• Lipoproteins, HDL
• Placebos
• Sex Hormone-Binding Globulin
• Testosterone
• Oxandrolone
• Luteinizing Hormone
• Follicle Stimulating Hormone
• Transaminases

Topics

• Adult
• Anabolic Agents (administration & dosage, adverse effects, therapeutic use)
• Body Mass Index
• Double-Blind Method
• Follicle Stimulating Hormone (blood)
• HIV Infections (complications, physiopathology)
• Humans
• Lipoproteins, HDL (blood)
• Luteinizing Hormone (blood)
• Male
• Middle Aged
• Oxandrolone (administration & dosage, adverse effects, therapeutic use)
• Placebos
• Sex Hormone-Binding Globulin (analysis)
• Testosterone (blood)
• Transaminases (blood)
• Weight Loss