The purpose of this study was to assess the effects of test-osterone replacement in hypogonadal men with AIDS wasting syndrome. The AIDS wasting syndrome is characterized by loss of lean body mass out of proportion to weight.6 Wasting syndrome is defined as a collection of symptoms that include the following: 1) fever lasting > 1 month, 2) weight loss of greater than 10% of baseline weight, and 3) night sweats and diarrhea lasting > 1 month. It is noted that hypogonadism occurs in over one half of all men with advanced HIV disease.5 It is unknown whether the resulting testosterone deficiency contributes to this profound catabolic state and loss of lean body mass. The development of therapeutic strategies to increase lean body mass is of critical importance as decreased lean body mass is associated with decreased survival.9 Hypothesized is that the loss of anabolic hormone, testosterone, in men with AIDS wasting could contribute to the critical loss of lean body mass. The protocol tested the change in fat-free mass, weight, muscle mass, lean body mass, perceived quality of life, and functional capacity as a result of providing therapeutic levels of testosterone.Subjects
Patients included 51 HIV-positive hypogonadal men (age 42 ±8 yrs) with wasting, defined as weight less than 90% of ideal body weight or weight loss greater than 10% of baseline weight. Hypogonadism was defined based on a decrease free testoster-one level (normal range 12.0 - 35 pg/ml). Inclusion was not limited based on CD4 count (testosterone treated = 188 ± 194 cell/mm3, placebo = 161 ± 235 cell/mm3) or viral load (testosterone treated = 177316 + 245190 copies/mi, placebo = 198455 + 249933 copies/ml). Patients receiving antiretroviral agents, including protease inhibitors, were required to be on a stable regimen for at least six weeks prior to study entry.Methods
Patients were randomized to receive testosterone enanthate 300mg or placebo intramuscularly every three weeks for 6 months (testosterone=26, placebo=25). Randomization was blinded to the patients and investigators. Prior to the first injection, subjects were admitted for a three day in-patient visit for baseline evaluation. Baseline evaluation included: hormonal, nutritional, body composition, functional, virologic, hematologic, and quality of life assessment. Patients underwent identical testing at six months. No exercise intervention was provided.