This Article Full Text Full Text (PDF) Submit a related Letter to the Editor Purchase Article View Shopping Cart Alert me when this article is cited Alert me when eLetters are posted Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Request Copyright Permission Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Bhasin, S. Articles by Beall, G. Search for Related Content PubMed PubMed Citation Articles by Bhasin, S. Articles by Beall, G.

Effects of Testosterone Replacement with a Nongenital, Transdermal System, Androderm, in Human Immunodeficiency Virus-Infected Men with Low Testosterone Levels¹

Division of Endocrinology, Metabolism, and Molecular Medicine, Charles R. Drew University of Medicine and Science (S.B., T.W.S., I.S.-H. R.S.), Los Angeles, California 90059; the Laboratory of Exercise Science, El Camino College (T.W.S.), Torrance, California 90504; Harbor-University of California-Los Angeles Medical Center (G.B.), Torrance, California 90502; SmithKline Beecham Pharmaceutical Co., Collegeville, PA 19426 (N.A.-S.); Center for Health Sciences, University of California School of Medicine (A.K., R.H.), Los Angeles, California 90024; and Karolinska Institute (S.A.), Stockholm, Sweden

Address all correspondence and requests for reprints to: Shalender Bhasin, M.D., Division of Endocrinology, Metabolism, and Molecular Medicine, Charles R. Drew University of Medicine and Science, Los Angeles, California 90059.

Although weight loss associated with human immunodeficiency virus (HIV) infection is multifactorial in its pathogenesis, it has been speculated that hypogonadism, a common occurrence in HIV disease, contributes to depletion of lean tissue and muscle dysfunction. We, therefore, examined the effects of testosterone replacement by means of Androderm, a permeation-enhanced, nongenital transdermal system, on lean body mass, body weight, muscle strength, health-related quality of life, and HIV-disease markers.

We randomly assigned 41 HIV-infected, ambulatory men, 18–60 yr of age, with serum testosterone levels below 400 ng/dL, to 1 of 2 treatment groups: group I, two placebo patches (n = 21); or group II, two testosterone patches designed to release 5 mg testosterone over 24 h. Eighteen men in the placebo group and 14 men in the testosterone group completed the 12-week treatment.

Serum total and free testosterone and dihydrotestosterone levels increased, and LH and FSH levels decreased in the testosterone-treated, but not in the placebo-treated, men. Lean body mass and fat-free mass, measured by dual energy x-ray absorptiometry, increased significantly in men receiving testosterone patches [change in lean body mass, +1.345 ± 0.533 kg (P = 0.02 compared to no change); change in fat-free mass, +1.364 ± 0.525 kg (P = 0.02 compared to no change)], but did not change in the placebo group [change in lean body mass, 0.189 ± 0.470 kg (P = NS compared to no change); change in fat-free mass, 0.186 ± 0.470 kg (P = NS compared to no change)]. However, there was no significant difference between the 2 treatment groups in the change in lean body mass. The change in lean body mass during treatment was moderately correlated with the increment in serum testosterone levels (r = 0.41; P = 0.02). The testosterone-treated men experienced a greater decrease in fat mass than those receiving placebo patches (P = 0.04). There was no significant change in body weight in either treatment group. Changes in overall quality of life scores did not correlate with testosterone treatment; however, in the subcategory of role limitation due to emotional problems, the men in the testosterone group improved an average of 43 points of a 0–100 possible score, whereas those in the placebo group did not change. Red cell count increased in the testosterone group (change in red cell count, +0.1 ± 0.1 10¹²/L) but decreased in the placebo group (change in red cell count, -0.2 ± 0.1 10¹²/L). CD4⁺ and CD8⁺ T cell counts and plasma HIV copy number did not significantly change during treatment. Serum prostate-specific antigen and plasma lipid levels did not change in either treatment group.

Testosterone replacement in HIV-infected men with low testosterone levels is safe and is associated with a 1.35-kg gain in lean body mass, a significantly greater reduction in fat mass than that achieved with placebo treatment, an increased red cell count, and an improvement in role limitation due to emotional problems. Further studies are needed to assess whether testosterone supplementation can produce clinically meaningful changes in muscle function and disease outcome in HIV-infected men.

This article has been cited by other articles:

				M. S. Rothman, D. B. Arciniegas, C. M. Filley, and M. E. Wierman The Neuroendocrine Effects of Traumatic Brain Injury J Neuropsychiatry Clin Neurosci, November 1, 2007; 19(4): 363 - 372. [Abstract] [Full Text] [PDF]

				M. Montano, J. N. Flanagan, L. Jiang, P. Sebastiani, M. Rarick, N. K. LeBrasseur, C. A. Morris, R. Jasuja, and S. Bhasin Transcriptional Profiling of Testosterone-Regulated Genes in the Skeletal Muscle of Human Immunodeficiency Virus-Infected Men Experiencing Weight Loss J. Clin. Endocrinol. Metab., July 1, 2007; 92(7): 2793 - 2802. [Abstract] [Full Text] [PDF]

				J. N. Miner, W. Chang, M. S. Chapman, P. D. Finn, M. H. Hong, F. J. Lopez, K. B. Marschke, J. Rosen, W. Schrader, R. Turner, et al. An Orally Active Selective Androgen Receptor Modulator Is Efficacious on Bone, Muscle, and Sex Function with Reduced Impact on Prostate Endocrinology, January 1, 2007; 148(1): 363 - 373. [Abstract] [Full Text] [PDF]

				S. Bhasin, G. R. Cunningham, F. J. Hayes, A. M. Matsumoto, P. J. Snyder, R. S. Swerdloff, and V. M. Montori Testosterone Therapy in Adult Men with Androgen Deficiency Syndromes: An Endocrine Society Clinical Practice Guideline J. Clin. Endocrinol. Metab., June 1, 2006; 91(6): 1995 - 2010. [Abstract] [Full Text] [PDF]

				T. W. Storer, L. J. Woodhouse, F. Sattler, A. B. Singh, E. T. Schroeder, K. Beck, M. Padero, P. Mac, K. E. Yarasheski, P. Geurts, et al. A Randomized, Placebo-Controlled Trial of Nandrolone Decanoate in Human Immunodeficiency Virus-Infected Men with Mild to Moderate Weight Loss with Recombinant Human Growth Hormone as Active Reference Treatment J. Clin. Endocrinol. Metab., August 1, 2005; 90(8): 4474 - 4482. [Abstract] [Full Text] [PDF]

				H. H. Choi, P. B. Gray, T. W. Storer, O. M. Calof, L. Woodhouse, A. B. Singh, C. Padero, R. P. Mac, I. Sinha-Hikim, R. Shen, et al. Effects of Testosterone Replacement in Human Immunodeficiency Virus-Infected Women with Weight Loss J. Clin. Endocrinol. Metab., March 1, 2005; 90(3): 1531 - 1541. [Abstract] [Full Text] [PDF]

				E.C. Creutzberg and R. Casaburi Endocrinological disturbances in chronic obstructive pulmonary disease Eur. Respir. J., November 2, 2003; 22(46_suppl): 76S - 80s. [Abstract] [Full Text] [PDF]

				S. Bhasin Testosterone Supplementation for Aging-Associated Sarcopenia J. Gerontol. A Biol. Sci. Med. Sci., November 1, 2003; 58(11): M1002 - 1008. [Abstract] [Full Text] [PDF]

				E. T. Schroeder, M. Terk, and F. R. Sattler Androgen therapy improves muscle mass and strength but not muscle quality: results from two studies Am J Physiol Endocrinol Metab, July 1, 2003; 285(1): E16 - E24. [Abstract] [Full Text] [PDF]

				I. Sinha-Hikim, S. M. Roth, M. I. Lee, and S. Bhasin Testosterone-induced muscle hypertrophy is associated with an increase in satellite cell number in healthy, young men Am J Physiol Endocrinol Metab, July 1, 2003; 285(1): E197 - E205. [Abstract] [Full Text] [PDF]

				S. Bhasin, A. B. Singh, R. P. Mac, B. Carter, M. I. Lee, and G. R. Cunningham Managing the Risks of Prostate Disease During Testosterone Replacement Therapy in Older Men: Recommendations for a Standardized Monitoring Plan J Androl, May 1, 2003; 24(3): 299 - 311. [Full Text] [PDF]

				L. J. Woodhouse, S. Reisz-Porszasz, M. Javanbakht, T. W. Storer, M. Lee, H. Zerounian, and S. Bhasin Development of models to predict anabolic response to testosterone administration in healthy young men Am J Physiol Endocrinol Metab, May 1, 2003; 284(5): E1009 - E1017. [Abstract] [Full Text] [PDF]

				T. W. Storer, L. Magliano, L. Woodhouse, M. L. Lee, C. Dzekov, J. Dzekov, R. Casaburi, and S. Bhasin Testosterone Dose-Dependently Increases Maximal Voluntary Strength and Leg Power, but Does Not Affect Fatigability or Specific Tension J. Clin. Endocrinol. Metab., April 1, 2003; 88(4): 1478 - 1485. [Abstract] [Full Text] [PDF]

				I. Sinha-Hikim, J. Artaza, L. Woodhouse, N. Gonzalez-Cadavid, A. B. Singh, M. I. Lee, T. W. Storer, R. Casaburi, R. Shen, and S. Bhasin Testosterone-induced increase in muscle size in healthy young men is associated with muscle fiber hypertrophy Am J Physiol Endocrinol Metab, July 1, 2002; 283(1): E154 - E164. [Abstract] [Full Text] [PDF]

				S. Basaria, J. T. Wahlstrom, and A. S. Dobs Anabolic-Androgenic Steroid Therapy in the Treatment of Chronic Diseases J. Clin. Endocrinol. Metab., November 1, 2001; 86(11): 5108 - 5117. [Abstract] [Full Text] [PDF]

				N. Dejucq and B. Jegou Viruses in the Mammalian Male Genital Tract and Their Effects on the Reproductive System Microbiol. Mol. Biol. Rev., June 1, 2001; 65(2): 208 - 231. [Abstract] [Full Text] [PDF]

				A. S. Dobs, P. S. Bachorik, S. Arver, A. W. Meikle, S. W. Sanders, K. E. Caramelli, and N. A. Mazer Interrelationships among Lipoprotein Levels, Sex Hormones, Anthropometric Parameters, and Age in Hypogonadal Men Treated for 1 Year with a Permeation-Enhanced Testosterone Transdermal System J. Clin. Endocrinol. Metab., March 1, 2001; 86(3): 1026 - 1033. [Abstract] [Full Text]

				D. P. Kotler Cachexia Ann Intern Med, October 17, 2000; 133(8): 622 - 634. [Abstract] [Full Text] [PDF]

				S. Grinspoon, C. Corcoran, K. Parlman, M. Costello, D. Rosenthal, E. Anderson, T. Stanley, D. Schoenfeld, B. Burrows, D. Hayden, et al. Effects of Testosterone and Progressive Resistance Training in Eugonadal Men with AIDS Wasting: A Randomized, Controlled Trial Ann Intern Med, September 5, 2000; 133(5): 348 - 355. [Abstract] [Full Text] [PDF]

				P. J. Snyder, H. Peachey, J. A. Berlin, P. Hannoush, G. Haddad, A. Dlewati, J. Santanna, L. Loh, D. A. Lenrow, J. H. Holmes, et al. Effects of Testosterone Replacement in Hypogonadal Men J. Clin. Endocrinol. Metab., August 1, 2000; 85(8): 2670 - 2677. [Abstract] [Full Text]

				M. Javanbakht, A. B. Singh, N. A. Mazer, G. Beall, I. Sinha-Hikim, R. Shen, and S. Bhasin Pharmacokinetics of a Novel Testosterone Matrix Transdermal System in Healthy, Premenopausal Women and Women Infected with the Human Immunodeficiency Virus J. Clin. Endocrinol. Metab., July 1, 2000; 85(7): 2395 - 2401. [Abstract] [Full Text]

				S. Bhasin, T. W. Storer, M. Javanbakht, N. Berman, K. E. Yarasheski, J. Phillips, M. Dike, I. Sinha-Hikim, R. Shen, R. D. Hays, et al. Testosterone Replacement and Resistance Exercise in HIV-Infected Men With Weight Loss and Low Testosterone Levels JAMA, February 9, 2000; 283(6): 763 - 770. [Abstract] [Full Text] [PDF]

				J. G. Rabkin, G. J. Wagner, and R. Rabkin A Double-blind, Placebo-Controlled Trial of Testosterone Therapy for HIV-Positive Men With Hypogonadal Symptoms Arch Gen Psychiatry, February 1, 2000; 57(2): 141 - 147. [Abstract] [Full Text] [PDF]

				C. Hadigan, C. Corcoran, T. Stanley, S. Piecuch, A. Klibanski, and S. Grinspoon Fasting Hyperinsulinemia in Human Immunodeficiency Virus-Infected Men: Relationship to Body Composition, Gonadal Function, and Protease Inhibitor Use J. Clin. Endocrinol. Metab., January 1, 2000; 85(1): 35 - 41. [Abstract] [Full Text]

				A. Negro-Vilar Selective Androgen Receptor Modulators (SARMs): A Novel Approach to Androgen Therapy for the New Millennium J. Clin. Endocrinol. Metab., October 1, 1999; 84(10): 3459 - 3462. [Full Text] [PDF]

				P. J. Snyder, H. Peachey, P. Hannoush, J. A. Berlin, L. Loh, D. A. Lenrow, J. H. Holmes, A. Dlewati, J. Santanna, C. J. Rosen, et al. Effect of Testosterone Treatment on Body Composition and Muscle Strength in Men Over 65 Years of Age J. Clin. Endocrinol. Metab., August 1, 1999; 84(8): 2647 - 2653. [Abstract] [Full Text]

				C. Corcoran and S. Grinspoon Treatments for Wasting in Patients with the Acquired Immunodeficiency Syndrome N. Engl. J. Med., June 3, 1999; 340(22): 1740 - 1750. [Full Text] [PDF]

				A. S. Dobs Is There a Role for Androgenic Anabolic Steroids in Medical Practice? JAMA, April 14, 1999; 281(14): 1326 - 1327. [Full Text] [PDF]

				The Use of Testosterone in the AIDS Wasting Syndrome AIDS Clinical Care, April 1, 1999; 1999(401): 1 - 1. [Full Text]

				N. F. Gonzalez-Cadavid, W. E. Taylor, K. Yarasheski, I. Sinha-Hikim, K. Ma, S. Ezzat, R. Shen, R. Lalani, S. Asa, M. Mamita, et al. Organization of the human myostatin gene and expression in healthy men and HIV-infected men with muscle wasting PNAS, December 8, 1998; 95(25): 14938 - 14943. [Abstract] [Full Text] [PDF]