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Department of Medicine, University of California San Francisco, Division of Endocrinology, San Francisco General Hospital, San Francisco, CA (KM, MS), Statistical and Data Analysis Center, Harvard University (RZ, TL, TU), Northwestern University Medical Center, Chicago, IL (JHV), National Institutes of Health, Bethesda, MD (MC), Departments of Medicine and Pharmacology and Cancer Institute, University of Pittsburgh, Pittsburgh, PA (MJE), University of Southern California Keck School of Medicine, Los Angeles, CA (FRS), University of California San Diego, San Diego, CA (CAB), Social and Scientific Systems, Inc, Silver Spring, MD (SS), University of Texas Southwestern Medical Center, Dallas, TX (RJA)
* To whom correspondence should be addressed. E-mail: kmulligan{at}sfghgcrc.ucsf.edu.
Context: Reduced energy intake is a primary factor in HIV-associated wasting. Megestrol acetate (MA) stimulates appetite and weight gain. However, much of the weight gained is fat, possibly as a result of MA-induced hypogonadism.
Objective: To determine whether co-administration of testosterone with MA could enhance lean body mass (LBM) accrual; and evaluate the effects of MA, alone or combined with testosterone, on sexual functioning and the hypothalamic-pituitary-adrenal axis.
Design: Randomized, double-blind, placebo-controlled multicenter trial.
Setting: Fourteen AIDS Clinical Trials Units in the United States.
Subjects: Seventy-nine HIV-positive men with 
5% weight loss or BMI <20 kg/m2.
Intervention: Subjects were randomized to receive MA (800 mg daily) plus testosterone enanthate (200 mg; MA/TE; n = 41) or placebo (MA/PL; n = 38) biweekly for 12 weeks.
Main Outcome Measures: Weight, body composition (bioelectric impedance analysis), adrenal and gonadal hormones, and sexual functioning (questionnaire).
Results: Both groups experienced robust increases in weight (median 5.3 and 7.3 kg in MA/TE and MA/PL, respectively), LBM (3.3 and 3.3 kg), and fat (3.0 and 3.8 kg). There were no significant differences between groups in the magnitude or composition of weight gain (P = 0.44, 0.90, and 0.11 for weight, LBM, and fat, respectively). Trough testosterone concentrations decreased to a greater extent in MA/PL (-12.3 vs. -6.1 nmol/L in MA/TE; P = 0.04). Cortisol levels became nearly undetectable in subjects with plasma MA levels >150 ng/mL. Sexual functioning was preserved with MA/TE but worsened in MA/PL.
Conclusions: MA produced robust weight gain. Co-administration of testosterone preserved sexual functioning but did not enhance LBM accrual.
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  C M Wilcox and M S Saag Gastrointestinal complications of HIV infection: changing priorities in the HAART era Gut, June 1, 2008; 57(6): 861 - 870. [Abstract] [Full Text] [PDF]
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 W. J. Evans Megestrol Acetate Use for Weight Gain Should Be Carefully Considered J. Clin. Endocrinol. Metab., February 1, 2007; 92(2): 420 - 421. [Full Text] [PDF]
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