"There has been very little research in the use of androgens [male hormones] to treat HIV-infected women," says Steven Grinspoon, MD, of the MGH Neuroendocrine Unit and Program in Nutritional Metabolism, the report's senior author. "We found that giving natural testosterone at levels that are normal for women produces significant improvement for patients with few other treatment options."
Earlier studies from the same group had shown that testosterone injections can improve the quality of life in men with the extreme muscle loss called AIDS-wasting syndrome. However, there is little information about gender-specific effects and treatments for HIV infection in women, who now represent almost one-third of diagnosed AIDS patients in the U.S. A 1998 study by the MGH researchers found that short-term use of skin patches that deliver normal levels of testosterone had no adverse effects on a group of women with HIV, and the investigators followed that finding with the current study.
A group of 57 HIV-infected women with lower-than-normal body weight and testosterone levels was enrolled in the trial. Half of them received skin patches designed to deliver testosterone at levels normal for women and the others received identical-appearing placebo patches. Upon entering the double-blinded study, all participants had extensive measurements taken of body weight and composition; of upper- and lower-body muscle strength, and of muscle function based on the distance walked in 6 minutes. Overall, study participants were found to have significant reductions in both muscle strength and function, an observation not previously documented in any study of HIV-infected women.
After the 6-month study period, which 52 participants completed, those who received testosterone patches were found to have significantly higher levels of the hormone, most returning to normal levels. Testosterone levels for the placebo group remained below normal or at the low end of the normal range. Although there were no significant changes in weight in either group the groups, the testosterone group had somewhat increased muscle mass.
In the tests of muscle strength and function, the group receiving testosterone showed significant improvement compared with measurements taken before the study. Placebo groups members, in contrast, lost both strength and muscle function during the study period. None of the study participants reported such potential side effects of testosterone treatment as alterations in their hair, skin or voice or any related metabolic changes.
"Although natural testosterone delivery products like the patches used in this study are not currently being marketed, they are in development at several pharmaceutical companies. When they do become available, it may be reasonable for physicians treating HIV-infected women to test patients' testosterone levels and attempt to restore levels that are reduced, says Grinspoon, an associate professor of Medicine at Harvard Medical School.
Grinspoon stresses that this therapy would only be appropriate for patients with documented low testosterone, who should be closely monitored during treatment. He and his colleagues are looking into longer-terms effects of testosterone replacement on muscles and bones. They also note that testosterone-replacement treatment should be studied for other groups of women with weight loss associated with serious illness.
The study's co-authors are first author Sara Dolan, NP, Stephanie Wilkie, NP, Negar Aliabadi and Meghan P. Sullivan, all of the MGH Program in Nutritional Metabolism; and Nesli Basgoz, MD, and Benjamin Davis, MD, of the MGH Infectious Disease Unit. The study was supported by grants from the National Institutes of Health and the Mary Fisher Clinical AIDS Research and Education Fund.
Massachusetts General Hospital, established in 1811, is the original and largest teaching hospital of Harvard Medical School. The MGH conducts the largest hospital-based research program in the United States, with an annual research budget of more than $400 million and major research centers in AIDS, cardiovascular research, cancer, cutaneous biology, medical imaging, neurodegenerative disorders, transplantation biology and photomedicine. In 1994, MGH and Brigham and Women's Hospital joined to form Partners HealthCare System, an integrated health care delivery system comprising the two academic medical centers, specialty and community hospitals, a network of physician groups, and nonacute and home health services.
Journal
Archives of Internal Medicine