HE PRIMARY AIM OF THERAPY IN wasting syndromes is to restore lean tissue. 1,2 The use of alimentation or appetite stimulants in wasting due to human immunodeficiency virus (HIV) has, however, resulted in fat deposition with little lean tissue gains. 3-6 Administration of HIV-protease inhibitors to patients with acquired immunodeficiency syndrome (AIDS) also results in weight gain, but most of the weight gained is body fat. 7-10 Alterations in the metabolic or endocrine milieu, 11,12 inadequate exercise, or other factors may be responsible for disproportionate fat vs lean body mass (LBM) gains in HIV infection. Recombinant growth hormone (rGH) 13,14 and androgen replacement therapy in men with low or borderline low serum testosterone concentrations 15,16 are effective in restoring LBM in men with HIV infection.
Serum testosterone concentrations are frequently in the low-normal range (lowest quartile, <500 ng/dl) in men with AIDS-wasting syndrome (AWS) and in other chronic wasting disorders. The response of patients in this group to androgen treatment has not been determined, however. Eighteen men with AWS (mean +/- standard error [SE]: 87% +/- 1% usual body weight; CD4 count 90 +/- 24) and borderline low serum testosterone concentrations (382 +/- 33 ng/dl) completed a 21-day placebo-controlled inpatient metabolic ward study comparing intramuscular (i.m.) placebo (n = 7) with low-dose (65 mg/week; n = 4) and high-dose (200 mg/week; n = 7) nandrolone decanoate, a testosterone analogue. Nitrogen balance, stable isotope-mass spectrometric measurement of de novo lipogenesis (DNL), resting energy expenditure, and gonadal hormone levels were measured. Both low-dose and high-dose nandrolone resulted in significant nitrogen retention (33-52 g nitrogen/14 days, representing gains of 0.5 to 0.9 kg lean tissue/week) compared with placebo (loss of 11 g nitrogen/week). This was reflected biochemically in a borderline significant reduction of high DNL (p < .06). Serum testosterone and gonadotropins were suppressed whereas resting energy expenditure was unchanged by nandrolone treatment. In 10 study subjects completing a 12-week open-label follow-up phase, body weight increased by 4.9 +/- 1.2 kg, including 3.1 +/- 0.5 kg lean body mass, and treadmill exercise performance also improved. In summary, nandrolone decanoate therapy in the absence of an exercise program in borderline hypogonadal men with AWS caused substantial nitrogen retention compared with placebo, similar in extent to the nitrogen retention previously achieved with recombinant growth hormone. It is reasonable to expand the criteria for androgen treatment in AWS to include at least patients in the lowest quartile of serum testosterone.
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