Effects of nandrolone decanoate therapy in borderline hypogonadal men withHIV-associated weight loss

Serum testosterone concentrations are frequently in the low-normal range (l owest 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 co mparing intramuscular (IM) placebo (n = 7) with low-dose (65 mg/week; n = 4 ) and high-dose (200 mg/week; n = 7) nandrolone decanoate, a testosterone a nalogue. 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 s ignificant 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 nit rogen/week). This was reflected biochemically in a borderline significant r eduction of high DNL (p < .06). Serum testosterone and gonadotropins were s uppressed whereas resting energy expenditure was unchanged by nandrolone tr eatment. In 10 study subjects completing n-label follow-up phase, body weig ht increased by 4.9 +/- 1.2 kg, including 3.1 +/- 0.5 kg lean body mass, an d treadmill exercise performance also improved. In summary, nandrolone deca noate therapy in the absence of an exercise program in borderline hypogonad al men with AWS caused substantial nitrogen retention compared with placebo , similar in extent to the nitrogen retention previously achieved with reco mbinant growth hormone. It is reasonable to expand the criteria for androge n treatment in AWS to include at least patients in the lowest quartile of s erum testosterone.