A double-blind, placebo-controlled trial of testosterone therapy for HIV-positive men with hypogonadal symptoms.
BACKGROUND
The goal was to evaluate the efficacy of testosterone in alleviation of hypogonadal symptoms (diminished libido, depressed mood, low energy, and depleted muscle mass) in men with symptomatic human immunodeficiency virus illness.


METHODS
Seventy-four patients were enrolled in a double-blind, placebo-controlled 6-week trial with bi-weekly testosterone injections, followed by 12 weeks of open-label maintenance treatment. Major outcome measures were Clinical Global Impressions Scale ratings for libido, mood, energy, and erectile function; Hamilton Depression Rating Scale scores, and Chalder Fatigue Scale scores. Body composition changes were assessed with bioelectric impedance analysis.


RESULTS
Seventy men completed the 6-week trial. Response rates, defined as much or very much improved libido, were 74% (28/38) for patients randomized to testosterone, and 19% (6/32) for placebo-treated patients (P<.001). Of the 62 completers with fatigue at baseline, 59% (20/34) receiving testosterone and 25% (7/28) receiving placebo reported improved energy (P<.01). Among the 26 completers with an Axis I depressive disorder at baseline, 58% of the testosterone-treated patients reported improved mood compared with 14% of placebo-treated patients (Fisher exact test = .08). With testosterone treatment, average increase in muscle mass over 12 weeks was 1.6 kg for the whole group, and 2.2 kg for the 14 men with wasting at baseline. Improvement on all parameters was maintained during subsequent open-label treatment for up to 18 weeks.


CONCLUSIONS
Testosterone is well tolerated and effective in the short-term treatment of symptoms of clinical hypogonadism in men with symptomatic human immunodeficiency virus illness, restoring libido and energy, alleviating depressed mood, and increasing muscle mass.
Rabkin
J G
JG
New York State Psychiatric Institute, Department of Psychiatry, College of Physicians and Surgeons, Columbia University, New York 10032, USA. jgr1@Columbia.edu
Wagner
G J
GJ
Rabkin
R
R
D000163:Acquired Immunodeficiency Syndrome / Q000150:complications* / Q000453:epidemiology; D045930:Anabolic Agents / Q000627:therapeutic use*; D015897:Comorbidity; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D007172:Erectile Dysfunction / Q000188:drug therapy / Q000453:epidemiology; D006801:Humans; D007006:Hypogonadism / Q000188:drug therapy* / Q000453:epidemiology; D008297:Male; D010919:Placebos; D020018:Sexual Dysfunctions, Psychological / Q000188:drug therapy* / Q000453:epidemiology; D013739:Testosterone / Q000031:analogs & derivatives* / Q000172:deficiency* / Q000627:therapeutic use
D045930:Anabolic Agents; D003692:Delayed-Action Preparations; D010919:Placebos; D013739:Testosterone; C016131:testosterone 17 beta-cypionate