705-T. Randomized Phase III Trial of Oxymetholone for the Treatment of HIV Wasting and Lipodystrophy

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Session 92 Poster Session
Switch Studies/Treatment of Lipodystrophy Syndromes
Session Time: 4:30-6:30 pm
Room 4E-F

705-T.

Randomized Phase III Trial of Oxymetholone for the Treatment of HIV Wasting and Lipodystrophy
U. R. Hengge*¹, K. Stocks¹, S. Unger¹, S. Faulkner², M. Goos¹, and R. Dudley²
¹Univ. of Essen, Germany and ²Unimed Pharmaceuticals, Inc., Deerfield, IL

Background: Although HAART has greatly impacted treatment of HIV infection, lipodystrophy and HIV wasting still represent unresolved problems in HIV therapy and patient care. Oxymetholone, a testosterone derivative, has been shown to promote weight gain in AIDS-associated wasting.
Methods: We analyzed the effects of oxymetholone (50 mg BID and TID) in a randomized (1:1:1), double-blind, placebo-controlled phase III study with 92 subjects (all on ART) experiencing unintended weight loss > 10% of ideal weight according to Broca with special emphasis on body composition measurements. 80 patients (69 men, 11 women; mean age: 38.8 years) completed the 16-week double-blind study phase.
Results: Mean weight gain was +3.7ą3.5 kg and +3.1ą2.7 kg in the oxymetholone groups (BID; n=25 vs TID; n=27) as opposed to +0.97ą3.4 kg in the placebo group (p< 0.0005). Importantly, statistically significant increases versus placebo were observed in body cell mass (30.6 before vs 32.5 after therapy), lean body mass (56.3 before vs 59.0 after therapy in the BID group) and body mass index (21.4 before vs 22.1 after therapy) exclusively in oxymetholone-treated patients. The extracellular mass to body cell mass ratio, an indicator of body composition, significantly improved from 0.87 to 0.80 (p < 0.0001). Total body fat was unchanged by oxymetholone treatment. Adverse events were mainly hepatic occurring in 14% of oxymetholone-treated patients with significant elevations of AST, ALT, and GGT; 2 patients (7.4%) in the BID arm experienced grade 3 and 4 liver toxicity compared with 6 (21.4%) in the TID arm.
Conclusions: Oxymetholone was found to have true anabolic effects in a double-blind, placebo-controlled phase III trial. The BID (100 mg/d) regimen appeared equally effective to TID (150 mg/d) dosing while displaying reduced liver toxicity. Due to its favorable protein anabolism, it may be recommended for therapy of wasting and lipodystrophy in HIV-infected subjects.

Š2002 9^th Conference on Retroviruses and Opportunistic Infections