725 - Abstract (11th CROI)

Session 100 Poster Abstracts
Dyslipidemias and Body Fat Abnormalities: Incidence, Risk Factors, Response to Therapy
Monday, 1:30 - 3:30 pm
Poster Hall

725

Oxymetholone for the Treatment of HIV Wasting: A Double-blind, Randomized, Placebo-controlled Phase 3 Trial in Eugonadal Men and Women
U R Hengge*¹, K Stocks², S Faulkner³, H Wiehler², C Lorenz⁴, W Jentzen⁵, A Mirmohammadsadegh⁶, D Hengge⁷, and G Ringham³
¹Univ. of Düsseldorf, Germany; ²Univ. of Essen STD Unit, Germany; ³Unimed Pharm. Inc., Deerfield, IL, USA; ⁴Hosp. Pharmacy, Univ. of Essen, Essen, Germany; ⁵Univ. of Essen, Germany; ⁶Joachim Kuhlmann AIDS Fndn., Essen, Germany; and ⁷Univ. of Bonn, Germany

Background: Despite highly active antiretroviral therapy (HAART), chronic involuntary weight loss still remains a serious problem in the care of HIV patients due to various alterations in energy metabolism and endocrine regulation. Previous studies in HIV-positive men undergoing androgen replacement therapy or treatment with recombinant growth hormone (rGH) have shown partial restoration of lean body mass, but these treatments have largely not been sufficiently studied in eugonadal individuals.

Methods: A double-blind, randomized, placebo-controlled trial of 89 HIV-positive eugonadal women and men with wasting assigned to the anabolic steroid oxymetholone (50 mg twice or three times daily) or placebo for 16 weeks was performed. Body weight, bioimpedance measurements, quality of life parameters, and appetite were analyzed.

Results: Oxymetholone led to a significant weight gain of 3.0±0.5 and 3.5±0.7 kg in the twice daily and three times daily groups, respectively (p <0.05 for each treatment versus placebo), while individuals in the placebo group gained an average of 1.0±0.7 kg. Body cell mass increased in the oxymetholone three times daily group (3.8±0.4 kg; p<.i> <0.0001) and in the oxymetholone three times daily group (2.1±0.6 kg; p <0.005). Significant improvements were noted in appetite and food intake, increased well-being, and reduced weakness by self-examination. The most important adverse event was liver-associated toxicity. Overall, 43% of patients in the three times daily, 25% of patients in the twice daily oxymetholone group, and 8% in the placebo group had a >5 times baseline increase for ALT, AST, or gGT, while other adverse events were not increased over those that occurred with placebo.

Conclusions: Oxymetholone can be considered an effective anabolic steroid in eugonadal male and female patients with AIDS-associated wasting. The twice daily (100 mg/day) regimen appeared to be equally effective as the three times daily (150 mg/day) regimen in terms of weight gain, LBM, and BCM and was associated with less liver toxicity.

Keywords: wasting; weight loss; anabolic steroids