Combination megestrol acetate, oxandrolone, and dietary advice restores weight in human immunodeficiency virus.

BACKGROUND: We examined changes in total body weight (TBW) and health-related quality of life (HRQL) during prolonged combination weight-gaining therapy and dietary advice in HIV. Design: This was a cohort study of patients initially randomized to single agent therapy for 2 months, megestrol acetate (800 mg daily), or oxandrolone (10 mg twice daily), followed by both agents and dietary advice for 5 months. METHODS: Two community health clinics and 1 urban infectious disease clinic were included, as were HIV-positive adult patients receiving highly active antiretroviral therapy with documented 5% weight loss. TBW and HRQL were measured after 7 months (7 m). RESULTS: Twenty-nine of 39 participants completed 7 m. The average sample age was 40 years, 75% were male, and 52% were of color at enrollment. Baseline mean TBW and body mass index (BMI) were 62.5 kg and 21 kg/m(2), respectively. Net gains in TBW, lean body mass, and fat during the 7 m were 5.3 kg (8.5% of baseline), 2.1 kg, and 3.1 kg, respectively (p < .01 for each). BMI increased to 23.1 kg/m(2) (p < .01). Dietary intake increased by 467 kcal/day (p = .03). Physical health improved by 5.7 (100-point scale, p < .01), and mental health was unchanged (-4.2, p = .11). In multivariable models, female gender (p < .01), lower baseline HIV viral load (p = .03), and increasing age (p < .01) were associated with TBW gain. Injection drug use (p < .01) and higher baseline HIV viral load (p < .01) were associated with reduction in physical health. CONCLUSIONS: Prolonged combination therapy with megestrol acetate, oxandrolone, and dietary advice could reverse weight loss and low BMI associated with incomplete viral suppression and improve physical health.