Therapeutic effects of nandrolone and testosterone in adult male HIV patients with AIDS wasting syndrome (AWS): A randomized, double-blind, placebo-controlled trial

HIV Clinical Trials

Volumn 11, Issue 4, 2010, Pages 220-229

  Sardar, Partha ^a   Jha, Ayan ^b   Roy, Deeptarka ^a   Majumdar, Uddalak ^a   Guha, Pradipta ^a   Roy, Sabyasachi ^a   Banerjee, Ramtanu ^a   Banerjee, Amit ^a   Bandyopadhyay, Dipanjan ^a  

^a MEDICAL COLLEGE AND HOSPITAL   (India)

^b ALL INDIA INSTITUTE OF HYGIENE AND PUBLIC HEALTH   (India)

Author keywords

AIDS wasting syndrome; nandrolone; testosterone

Indexed keywords

NANDROLONE DECANOATE; PLACEBO; TESTOSTERONE; TESTOSTERONE ENANTATE;

ADULT; ARTICLE; BODY MASS; BODY WEIGHT; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTED PATIENT; MAJOR CLINICAL STUDY; MALE; OUTCOME ASSESSMENT; PRIORITY JOURNAL; QUALITY OF LIFE; RANDOMIZATION; RANDOMIZED CONTROLLED TRIAL; SKINFOLD THICKNESS; THERAPY EFFECT; WAIST CIRCUMFERENCE; WASTING SYNDROME;

ADULT; BODY COMPOSITION; BODY MASS INDEX; DOUBLE-BLIND METHOD; FOLLICLE STIMULATING HORMONE; HIV; HIV INFECTIONS; HIV WASTING SYNDROME; HUMANS; INJECTIONS, INTRAMUSCULAR; LUTEINIZING HORMONE; MALE; NANDROLONE; QUALITY OF LIFE; SKINFOLD THICKNESS; TESTOSTERONE; WAIST CIRCUMFERENCE; WEIGHT GAIN;

EID: 78049425043     PISSN: 15284336     EISSN: None     Source Type: Journal    
DOI: 10.1310/hct1104-220     Document Type: Article

References (33)

1. Siddiqui J, Phillips AL, Freedland ES, Sklar AR, Darkow T, Harley CR. Prevalence and cost of HIV-associated weight loss in a managed care population. Curr Med Res Opin. 2009;25(5):1307-1317.
2. Mangili A, Murman DH, Zampini AM, Wanke CA. Nutrition and HIV infection: review of weight loss and wasting in the era of highly active antiretroviral therapy from the nutrition for healthy living cohort. Clin Infect Dis. 2006;42(6):836-842.
3. Tang AM, Forrester J, Spiegelman D, Knox TA, Tchetgen E, Gorbach SL. Weight loss and survival in HIV-positive patients in the era of highly active antiretroviral therapy. J Acquir Immune Defi c Syndr. 2002;31:230-236.
4. Shikuma CM, Zackin R, Sattler F, Mildvan D, Nyangweso P, Alston B, Evans S, Mulligan K; AIDS Clinical Trial Group 892 Team. Changes in weight and lean body mass during highly active antiretroviral therapy. Clin Infect Dis. 2004;39(8):1223-1230.
5. Strawford A, Hellerstein M. The etiology of wasting in the human immunodefi ciency virus and acquired immunodeficiency syndrome. Semin Oncol. 1998;25:76-81.
6. Corcoran C, Grinspoon S. Treatments for wasting in patients with the acquired immunodefi ciency syndrome. N Engl J Med. 1999;340:1740-1750.
7. Nemechek PM, Polsky B, Gottlieb MS. Treatment guidelines for HIV-associated wasting. Mayo Clin Proc. 2000;75:386-394.
8. Ottery FD, Walsh D, Strawford A. Pharmacologic management of anorexia/cachexia. Semin Oncol. 1998;25:35-44.
9. Oster MH, Enders SR, Samuels SJ, et al. Megestrol acetate in patients with AIDS and cachexia. Ann Intern Med. 1994;121:400-408.
10. Von Roenn JH, Armstrong D, Kotler D P, et al. Megestrol acetate in patients with AIDS-related cachexia. Ann Intern Med. 1994;121(6):393-399.
11. Hoh R, Pelfini A, Neese RA, et al. De novo lipogenesis predicts short-term body-composition response by bioelec-trical impedance analysis to oral nutritional supplements in HIV-associated wasting. Am J Clin Nutr. 1998;68(1): 154-163.
12. Silva M, Skolnik PR, Gorbach SL, et al. The effect of pro tease inhibitors on weight and body composition in HIV-infected patients. AIDS. 1998;12(13):1645-1651.
13. Schwenk A, Beisenherz A, Kremer G, Diehl V, Salzberger B, Fatkenheuer G. Bioelectrical impedance analysis in HIV-infected patients treated with triple antiretroviral treatment. Am J Clin Nutr. 1999;70:867-873.
14. Berger D, Cimoch P, Nemechek P, Meyer KL. Measurement of body cell mass in patients receiving highly active antiretroviral therapy (HAART). In: Program and abstracts of the 37th Annual Meeting of the Interscience Conference on Antimicrobial Agents and Chemotherapy; September to October 1997; Toronto, Ontario.
15. Zueman D, Teixeira A, Olivieri M, Marks M. Correlation between body composition, caloric intake and plasma viral load in HIV infected patients. Nutrition. 1997;13:293A.
16. Schambelan M, Mulligan K, Grunfeld C, et al. Recombinant human growth hormone in patients with HIV-associated wasting. A randomized, placebo-controlled trial. Serostim Study Group. Ann Intern Med. 1996;125(11):873-882.
17. Strawford A, Barbieri T, Neese R, et al. Effects of nan-drolone decanoate therapy in borderline hypogonadal men with HIV associated weight loss. J Acquir Immune Defi c Syndr Hum Retrovirol. 1999;20(2):137-146.
18. Forbes GB. The effect of anabolic steroids on lean body mass: the dose response curve. Metabolism. 1985, 34:571-573.
19. Forbes GB, Porta CR, Herr BE, Griggs R. Sequence of changes in body composition induced by testosterone and reversal of changes after drug is stopped. JAMA. 1992;267:397-399.
20. Harris JA, Benedict FG. A Biometric Study of Basal Metabolism in Man. Washington, DC: Carnegie Institute of Washington; 1919.
21. Mulligan K, Zackin R, Clark RA, et al. Effect of nandrolone decanoate therapy on weight and lean body mass in HIV-infected women with weight loss: a randomized, double-blind, placebo-controlled, multicenter trial. Arch Intern Med. 2005:578-585.
22. Saha B, Rajadhyaksha GC, Ray SK. Beneficial effects of nandrolone decanoate in wasting associated with HIV. J Indian Med Assoc. 2009;107(5):295-299.
23. Gold J, Batterham MJ, Rekers H, et al. Effects of nan-drolone decanoate compared with placebo or testosterone on HIV-associated wasting. HIV Med. 2006;7(3): 146-155.
24. Kelkar D, Deshpande AK. Hypogonadism & HIV wasting: an Indian scenario. Presented at: International Conference on AIDS; July 7-12, 2002. Abstract B10335.
25. Singh RB, Niaz MA, Beegom R, Wander GS, Thakur AS, Rissam HS. Body fat percent by bioelectrical impedance analysis and risk of coronary artery disease among urban men with low rates of obesity: the Indian paradox. J Am Coll Nutr. 1999;18(3):268-273.
26. Grinspoon S, Corcoran C, Askari H, et al. Effects of androgen administration in men with the AIDS wasting syndrome. A randomized, double-blind, placebo-controlled trial. Ann Intern Med. 1998:18-26. (Pubitemid 28304648)
27. Coodley GO, Coodley MK. A trial of testosterone therapy for HIV-associated weight loss AIDS. 1997;11:1347-1352.
28. Storer TW, Woodhouse LJ, Sattler F, Singh AB. 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. 2005;90:4474-4482.
29. Grinspoon S, Corcoran C, Lee K, et al. Loss of lean body and muscle mass correlates with androgen levels in hypogonadal men with acquired immunodeficiency syndrome and wasting. J Clin Endocrinol Metab. 1996;81(11):4051-4058.
30. Merenich JA, McDermott MT, Asp AA, Harrison SM, Kidd GS. Evidence of endocrine involvement early in the course of human immunodefi ciency virus infection. J Clin Endocrinol Metab. 1990;70:566-571.
31. Raffi F, Brisseau JM, Planchon B, Remi J P, Barrier JH, Grolleau JY. Endocrine function in 98 HIV-infected patients: a prospective study. AIDS. 1991;5:729-733.
32. Dobs AS, Dempsey MA, Ladenson PW, Polk BF. Endocrine disorders in men infected with human immunodefi ciency virus. Am J Med. 1988;84:611-616.
33. Wachtel T, Piette J, Mor V, Stein M, Fleishman J, Carpenter C. Quality of life in persons with human immunodeficiency virus infection: measurement by the Medical Outcomes Study instrument. Ann Intern Med. 1992;116:129-137.