NANDROLONE DECANOATE IN HIV-INFECTED MEN W/ MILD TO MOD WEIGHT LOSS WITH RHGH

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。目的：我们比较了两周服用150毫克诺龙和安慰剂治疗轻度至中度体重减轻的hiv感染男性的有效性，并对比了其与美国食品和药物管理局批准的重组人（rh）GH治疗方案的效果。方法：在这个安慰剂对照、随机、12周的试验中，双盲给药安慰剂和诺龙（150 mg，每两周一次），rhGH （6 mg，每天一次）以开放标签的方式给药。参与者是6个月内体重减轻5-15%并接受稳定抗逆转录病毒治疗超过12周的艾滋病毒感染男性。在基线和12周后评估瘦体质量（LBM）、肌肉表现、身体功能、耐力、激素水平、胰岛素敏感性、性功能、生活质量和食欲。结果：诺龙组双能x线吸收扫描LBM增加（+1.6 ~ 0.3 kg）明显高于安慰剂组（+0.4 ~ 0.3 kg, P < 0.05）；然而，与rhGH （+2.5 ~ 0.3 kg）相比，诺龙对lbm的改变没有显著性差异。与安慰剂相比，诺龙给药与无脂质量（+1.6 ~ 0.3 kg）、体细胞质量（+1.0 ~ 0.2 kg）和细胞内水（+0.9 ~ 0.2 kg）的显著增加有关；这些变化在诺龙组与rhGH组没有显著差异。与诺龙和安慰剂相比，rhGH治疗与更大的全身脂肪量损失、更高频率的药物相关不良反应和治疗中断以及比诺龙更大的细胞外水增加有关。诺龙治疗对健康感知的改善比rhGH和性功能的改善更大。恶病质/厌食症评分、医疗资源使用和胰岛素敏感性没有显著变化。结论：我们得出结论，诺龙在改善轻度至中度体重减轻的hiv感染男性瘦体重方面优于安慰剂，与美国食品和药物管理局批准的rhGH方案没有显著差异。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Objective: We compared the effectiveness of a biweekly regimen of 150 mg nandrolone with placebo in HIV-infected men with mild to moderate weight loss and contrasted its effects against a Food and Drug Administration-approved regimen of recombinant human (rh)GH. Methods: In this placebo-controlled, randomized, 12-wk trial, placebo and nandrolone (150 mg im biweekly) 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 more than 12 wk. 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 wk. Results: Nandrolone administration was associated with a greater increase in LBM (+1.6 ¿ 0.3 kg) by dual-energy x-ray absorptiometry scan than placebo (+0.4 ¿ 0.3 kg; P < 0.05); however, the change in LBMs with nandrolone was not significantly different from rhGH (+2.5 ¿ 0.3 kg). Nandrolone administration was also associated with significantly greater gains in fat-free mass (+1.6 ¿ 0.3 kg), body cell mass (+1.0 ¿ 0.2 kg), and intracellular water (+0.9 ¿ 0.2 kg) than placebo; these changes in the nandrolone group were not significantly different from the 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 extracellular 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 use, and insulin sensitivity did not significantly change. Conclusion: We conclude that nandrolone is superior to placebo and not significantly different from a Food and Drug Administration-approved regimen of rhGH in improving lean body mass in HIV-infected men with mild to moderate weight loss.