Testosterone therapy for human immunodeficiency virus-positive men with and without hypogonadism

This study was designed to evaluate the safety and effectiveness of testost erone therapy for clinical symptoms of hypogonadism (low libido, low mood, low energy, loss of appetite/weight) in human immunodeficiency virus-positi ve men with CD4 cell counts less than 400 cells/mm(3) and deficient or low normal serum testosterone levels. The trial consisted of 8 weeks of open tr eatment with 400 mg of intramuscular testosterone cypionate biweekly. Respo nders were maintained at this dosage for another 4 weeks and then were rand omized in a double-blind, placebo-controlled, g-week discontinuation trial. Of the 112 men who completed at least 8 weeks of treatment, 102 (91%) were rated as responders on a global assessment of sexual desire/function. Of t he 34 study completers with major depressive disorder and/or dysthymia, 79% reported significant improvement in mood at week 8. Average weight change was a gain of 3.7 pounds, with 45% gaining more than 5 pounds. Eighty-four men entered and 77 completed the double-blind phase; of these, 78% of compl eters randomized to testosterone and 13% randomized to placebo maintained t heir response. No significant medical or immunologic adverse effects were i dentified. Testosterone therapy was well tolerated and effective in amelior ating symptoms of clinical hypogonadism, and equally so for men with and wi thout testosterone deficiency. For patients with major depression and/or dy sthymia, improvement was equal to that achieved with standard antidepressan ts.