The goal of the proposed study was to assess the efficacy of testosterone enanthate in maintaining or improving lean body mass and determining the impact on quality of life in men with AIDS-associated wasting and documented low testosterone. Wasting is a major cause of morbidity and a predictor or mortality in AIDS and weight loss in AIDS is strongly and independently linked to worse symptoms and physical functioning. Testosterone is an anabolic steroid and there is anecdotal evidence for its use in promoting weight gain in men with HIV infection. Studies in healthy volunteers also support the anabolic effect of testosterone. Testosterone treatment improves mood and sexual functioning and leads to increased energy levels in hypogonadal men without HIV-infection. Hypogonadism has been well described in men with AIDS and particularly in HIV-infected men with wasitng; therefore, it is reasonable to test the efficacy of testosterone for HIV related wasting. We planned a three month, randomized, double-masked, placebo controlled clinical trial of testosterone therapy. Unfortunately, the study was closed without recruiting subjects. Recruitment was attempted through a variety of methods: advertisements placed multiple times in local Baltimore and Washington, DC community, gay and daily newspapers; flyers were posted at area clinics serving large HIV-infected populations; the protocol was listed in the American Foundation for AIDS Research Treatment Directory; and charts of patients scheduled for a visit to our HIV clinic were reviewed daily. In January, funding became available to pay subjects $50 for their time. Of 146 potential subjects who called for information, only twenty seven (18.5%) were eligible and agreed to screening. Major reasons for ineligibility included: current use of illicit drugs, less than 10% weight loss or current use of testosterone. Significant reasons for refusing screening after learning about the protocol included: objection to use of the placebo, expectations for larger payments and plans to seek testosterone from their primary provider or other sources. Of the 27 men screened, twelve had serum testosterone above the protocol's cut-off values. Those subjects remaining eligible all opted to enter a trial, similar to ours, testing a testosterone scrotal patch.
Showing the most recent 10 out of 1014 publications
