Use of Anabolic Steroids in Patients Who Have HIV/AIDS

Of the 3 orally active anabolic steroids, Oxandrolone has been studied in HIV-infected patients more extensively than has Oxymetholone. Stanozolol is used for the treatment of hereditary angioedema and has not been used for its anabolic effect in this patient population to any great extent. Use of the steroid oxandrolone is associated with significant gains in weight and body cell mass in HIV-positive men who had experienced HIV-related wasting, according to an American study published in the March edition of the Journal of Acquired Immune Deficiency Syndromes. However, although the steroid increased muscle mass, it did not improve endurance and caused side-effects, including an increase in levels of ‘bad’ LDL cholesterol and elevations in liver enzymes. Unintentional loss of just 3% of body weight has been associated with poorer survival in HIV-positive individuals. Although the use of antiretroviral therapy has led to a significant decrease in the prevalence of unintended weight loss, it is still common, even amongst people taking HIV treatment.

One of the earlier studies of Oxandrolone in HIV-infected patients was begun before the introduction of the PIs. Sixty-three HIV-infected men with a loss of body weight greater than 10% were randomized to receive placebo; Oxandrolone, 5 mg/d or Oxandrolone, 15 mg/d. The patients who received 15 mg/d of oxandrolone gained weight throughout the 16-week period, whereas those who received 5 mg/d of Oxandrolone maintained their weight. In contrast, the patients who received placebo continued to lose weight.

In a follow-up study, which has not yet been published, patients were randomized to placebo or to 1 of 3 dosages of Oxandrolone - 20 mg/d, 40 mg/d or 80 mg/d (C. Grunfeld, unpublished data, 1998). The patients in the group who received 40 mg/d had the most statistically significant weight gain. However, both the patients in this group and those who received 80 mg/d showed significant increases in serum levels of liver transaminases.

A study published in 1999 sought to determine whether a regimen of supra physiologic doses of androgen (testosterone) plus an anabolic steroid (Oxandrolone) would improve the LBM and strength gains achieved with progressive resistance exercise in HIV-infected men who had experienced weight loss. A second objective of the study was to determine whether antiretroviral therapy with a PI prevented lean body anabolism.

All subjects in the study participated in supervised progressive resistance exercise for 8 weeks. At the same time, they received testosterone, 100 mg/wk, by intramuscular injection. Twenty-four eugonadal men were then randomized to either placebo or Oxandrolone, 20 mg/d. Twenty-two patients completed the study. The results indicated that compared with patients who received placebo, those who received Oxandrolone experienced improved nitrogen balance (P = .05); increased LBM (P = .005); and increased muscle strength, as judged by either maximum weight lifted (P = .02 to .05) or dynamometry (P = .01 to .05). The results were similar regardless of whether the patients were taking a PI. However, compared with placebo, Oxandrolone was associated with a statistically significant decrease in blood levels of high-den-sity lipoprotein (HDL) cholesterol (P < .001).

Because all patients in the study participated in progressive resistance training and received testosterone, only an additive effect of Oxandrolone versus placebo was being determined. Therefore, the study appears to be valid even though the number of patients enrolled was small. On the other hand, had the design of the study called for dividing the patients into multiple groups, so that not all patients received testosterone or participated in progressive resistance exercise, the number of patients required to reach statistical significance would have been much higher.

The conclusions that can be drawn from the study are that Oxandrolone  20 mg/d, added to a program consisting of both progressive resistance exercise and physiologic doses of testosterone improved the anabolic and functional responses in patients who showed HIV-related weight loss.

Only 1 study of Oxymetholone in HIV-infected patients has been reported. This study was a nonblinded pilot trial that was completed in Germany and reported in 1996. Patients were randomly assigned to receive either Oxymetholone (14 patients) or Oxymetholone plus ketotifen (16 patients). Ketotifen is an H1-receptor antagonist (ie, antihista- mine) that has been shown to block tumor necrosis factor a. The patients receiving the medications under study were compared with 30 matched control patients who met the same inclusion criteria, such as advanced HIV infection and chronic cachexia. On completion of the twelve-week double-blind phase of the study, all the patients were offered the option of remaining on the study for a further twelve weeks and receiving an open label 20mg Oxandrolone dose a day. By the end of this period, there were no differences in weight between patients and liver function ceased to be significantly different from baseline.

Although the investigators note that treatment with the steroid was generally “well tolerated” they note that over 5% of patients had moderate or severe increases in levels of liver enzymes and that “LDL levels decreased and HDL levels increased.”