BRISTOL-MYERS' MEGACE FOR AIDS-RELATED CACHEXIA

Executive Summary

BRISTOL-MYERS' MEGACE FOR AIDS-RELATED CACHEXIA (weight loss) is under study in a five-center, placebo-controlled trial. Total enrollment is expected to reach 100 patients whose body weight loss from pre-illness levels was at least 10%. Mead Johnson, the study's sponsor, recently obtained FDA permission to proceed with the trial. Megace (megestrol) is currently approved as a treatment for breast cancer. Only one center, Northwestern Memorial Hospital in Chicago, has been selected as yet. The hospital was involved in a pilot study of Megace in 14 patients who were also receiving Retrovir. That study was published in the Nov. 15 issue of the Annals of Internal Medicine. Preliminary results of that study, which reported on 10 patients, were presented in June at the Fourth International AIDS Conference in Stockholm. More recent results of the Megace pilot study on all 14 patients show an average weight gain of .5 kg per week after a median 10 weeks on therapy. "The average weight gain for the entire group is 6.3 kg," Von Roenn, et al., reported. "Therapy has been well tolerated [and] no patient developed peripheral edema, evidence of thromboembolic phenomenon or impotence. All patients reported significant improvement in appetite while on therapy." The researchers noted that one of the 14 patients discontinued Megace because of "progressive weakness, progressive Kaposi's sarcoma, and disinterest in his body image and appetite."