Long-term testosterone therapy in HIV-positive women is safe and has significant benefits, researchers report in the May 15th edition of AIDS. The US investigators found that 18 months of testosterone treatment improved women’s lean body weight, bone density and mood, without causing side-effects.
Earlier research has shown that HIV-positive women frequently have hormone deficiencies, including low levels of testosterone. This has been associated with reduced lean body mass and bone mineral density, as well as poorer quality of life. Short-term studies have demonstrated that these can be improved with testosterone treatment, and that this therapy does not involve a significant risk of side-effects.
Investigators from the Massachusetts General Hospital and Harvard Medical Study wanted to see how safe and effective longer-term testosterone therapy was in HIV-positive women.
They therefore designed a placebo-controlled trial involving 25 women aged between 18 and 55 years. On recruitment to the study, the women all had a free testosterone level below 3.0pg/ml, the normal median range for women. Furthermore, all had low bone mineral density and low body weight (average body mass index being 22.8kg/m2). The women were assessed at regular intervals over an 18-month period and the outcomes measured were changes in testosterone levels, lean body mass, bone mineral density, mood and sexual function. The safety of testosterone treatment was assessed by monitoring blood lipids and liver function, hair pattern, acne, and menstrual cycle.
A total of 13 women were randomised to receive testosterone therapy at a dose of 300mg twice weekly. The remaining twelve women received a placebo.
Levels of testosterone increased significantly in the women who received the treatment but remained essentially unchanged in those randomised to take the placebo (p = 0.001).
Body mass index (p = 0.03), weight (p = 0.03) and lean body mass (p = 0.04) all improved significantly in the women who received testosterone, but remained stable in those taking the placebo.
Furthermore, testosterone therapy was associated with improvements in bone mineral density in the hip (p = 0.02) and thigh (p = 0.01). By contrast, slight losses in bone were observed in the women who received the placebo.
Treatment with testosterone also improved quality of life, with women who received this treatment having lower depression scores after 18 months than those who took the placebo (p = 0.02). In addition, testosterone treatment was associated with fewer problems affecting sexual function (p = 0.01).
There was no evidence that testosterone treatment caused side-effects. Lipid levels were comparable in the women who received treatment and the placebo, as was liver function. Nor did testosterone therapy cause changes in hair patterns or the menstrual cycle. Furthermore, the investigators found that testosterone was not associated with acne.
“This study is the first to investigate the effects of testosterone use over 18 months among HIV-infected women”, write the investigators. They add “we now show that testosterone is well tolerated over a long treatment period…we demonstrate that testosterone use among HIV-infected women with relatively low androgen levels, weight, and bone mineral density resulted in a significant increase in lean mass, weight, bone mineral density…and improvement in quality of life”.
As earlier research has suggested that many HIV-positive women have low testosterone levels, the investigators believe that “a sizable population…might benefit from testosterone administration.”
They note the safety of testosterone therapy writing “study-related adverse events were similar between groups”. However, as the study population was small, the investigators conclude, “further studies of long-term testosterone are necessary in women with HIV, as this treatment strategy may ultimately prove useful for the large number of women with low androgen levels, bone loss, and reduced quality of life.”