A randomized comparative trial of testosterone and protein supplements forweight loss in HIV plus men

This report presents findings from a randomized trial that compared the eff icacy of 1) 400 mg biweekly IM injections of testosterone plus daily "place bo" standard nutritional supplements (containing 8 g of protein per serving ), 2) high protein (37 g per serving) supplements and placebo IM injections , and 3) both testosterone and high protein supplements, in the treatment o f HIV-related weight loss. Sixty-five HIV+ men with less than or equal to 9 0% of normative body weight or body cell mass entered the study, of whom 54 (83%) completed the 12-week trial. In an intention to treat analysis, the response rates (defined as an increase of at least 5% in the ratio of body cell mass to height) for testosterone (55%), high protein supplements (62%) , and both testosterone and protein supplements (73%) were statistically si milar (p = NS). Amount of change in body weight, body cell mass, fat free m ass and body fat from baseline to Week 12 las measured by bioelectric imped ance analysis), all of which were statistically significant within each gro up, did not differ across the three groups. Among all completers, the avera ge gain in body weight and body cell mass after 12 weeks was 3.5 kgs and 2. 0 kgs, respectively; 77% of the increase in body weight was fat free body m ass, compared to 23% fat. These data support the efficacy of both testoster one and high protein supplements as independent treatments for HIV-related weight loss, but do not demonstrate a further advantage of combining the tr eatments. (C) 2001 Elsevier Science Inc. All rights reserved.