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Testosterone Supplementation of Megestrol Therapy Does Not Enhance Lean Tissue Accrual in Men with Human Immunodeficiency Virus-Associated Weight Loss: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial

Department of Medicine (K.M., M.S.), University of California, San Francisco, Division of Endocrinology, San Francisco General Hospital, San Francisco, California 94110; Statistical and Data Analysis Center (R.Z., T.L., T.U.), Harvard University, Boston, Massachusetts 02115; Northwestern University Medical Center (J.H.V.R.), Chicago, Illinois 60611; National Institutes of Health (M.A.C), Bethesda, Maryland 20892; Departments of Medicine and Pharmacology and Cancer Institute (M.J.E.), University of Pittsburgh, Pittsburgh, Pennsylvania 15213; University of Southern California Keck School of Medicine (F.R.S.), Los Angeles, California 90033; University of California, San Diego (C.A.B.), San Diego, California 92103; Social and Scientific Systems, Inc. (S.S.), Silver Spring, Maryland 20910; and University of Texas Southwestern Medical Center (R.J.A.), Dallas, Texas 75390

Address all correspondence and requests for reprints to: Kathleen Mulligan, Ph.D., Division of Endocrinology, San Francisco General Hospital, Building 30, Room 3501K, 1001 Potrero Avenue, San Francisco, California 94110. 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: The objective of the study was to determine whether coadministration 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: This was a randomized, double-blind, placebo-controlled, multicenter trial.

Setting: Fourteen AIDS Clinical Trials Units in the United States participated in the study.

Subjects: Seventy-nine HIV-positive men with 5% or more weight loss or body mass index less than 20 kg/m² took part in the study.

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 wk.

Main Outcome Measures: Weight, body composition (bioelectric impedance analysis), adrenal and gonadal hormones, and sexual functioning (questionnaire) were measured.

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/liter in MA/TE; P = 0.04). Cortisol levels became nearly undetectable in subjects with plasma MA levels greater than 150 ng/ml. Sexual functioning was preserved with MA/TE but worsened in MA/PL.

Conclusions: MA produced robust weight gain. Coadministration of testosterone preserved sexual functioning but did not enhance LBM accrual.

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