Objective. We compared the effectiveness of a biweekly regimen of 150 mg nandrolone to placebo in HIV-infected men with mild to moderate weight loss, and contrasted its effects against an FDA-approved regimen of rhGH.

Methods. In this placebo-controlled, randomized, 12-week trial, placebo and nandrolone (150 mg intramuscularly bi-weekly) were administered double blind, and rhGH (6 mg sc daily) was administered in an open label manner. Participants were HIV-infected men with 5-15% weight loss over 6 months and on stable antiretroviral therapy for >12-weeks. Lean body mass (LBM), muscle performance, physical function, endurance, hormone levels, insulin sensitivity, sexual function, quality of life, and appetite were assessed at baseline and after 12-weeks.

Results. Nandrolone administration was associated with a greater increase in LBM (+1.6 ± 0.3kg) by DEXA scan than placebo (+0.4 ± 0.3kg, P < 0.05); however, the change in LBMs with nandrolone was not significantly different from rhGH (+2.5 ± 0.3kg). Nandrolone administration was also associated with significantly greater gains in FFM (+1.6 ± 0.3kg), body cell mass (+1.0 ± 0.2kg), intracellular water (+0.9 ± 0.2kg) than placebo; these changes in nandrolone group were not significantly different from rhGH group. rhGH administration was associated with greater loss of whole body fat mass and higher frequency of drug-related adverse effects and treatment discontinuations than nandrolone and placebo, and a greater increase in extra-cellular water than nandrolone. Nandrolone treatment was associated with greater improvements in perception of health than rhGH, and sexual function than placebo. The cachexia/anorexia scores, health care resource utilization, insulin sensitivity did not significantly change.

Conclusion. We conclude that nandrolone is superior to placebo and not significantly different from an FDA-approved regimen of rhGH in improving lean body mass in HIV-infected men with mild to moderate weight loss.