Approaches to the AIDS Wasting Syndrome.

AIDS: AIDS Wasting Syndrome (AWS), a devastating consequence of HIV disease, is defined as involuntary loss of body mass and a disproportionate loss of muscle mass. Its exact mechanisms are unknown, but some of the side effects of drugs or opportunistic infections can increase the likelihood of developing AWS. Low testosterone levels are associated with AWS in both men and women, and testosterone replacement therapy is indicated. Other anabolic therapies are available, including serostim (growth hormone), but the cost is prohibitive. Nandrolone, Oxandrolone, and Megestrol Acetate are other medications that have some effectiveness in combating AWS. Thalidomide has shown promise in treating wasting and contact information is provided for a compassionate use program. The need for proper nutrition and exercise is also emphasized.^ieng

Thalidomide's comeback.

AIDS: Thalidomide shows a significant ability to eliminate painful mouth ulcers in HIV patients and is also effective in reversing wasting and clearing up severe diarrhea caused by microsporidiosis. However, the drug comes with several side effects. Side effects include peripheral neuropathy, neutropenia, sedation, rash, and a small but statistically significant rise in HIV viral loads. Many physicians are not using Thalidomide due to the publicity that was generated from the birth defects that it caused. Thalidomide is available free through a compassionate use program and through an Investigational New Drug (IND) protocol. Contact information is included for both of these programs.^ieng

Thalidomide study.

AIDS: Preliminary findings from a study on the effects of thalidomide on HIV-related wasting syndrome are encouraging. The study shows that at least half of the weight gained by participants was in the form of lean body mass. Side effects included declines in neutrophil counts and pain or tingling in the hands and/or feet. A 0.3 log increase in viral load and no decrease in TNF-alpha levels were also noted. Celgene, the manufacturer of thalidomide, has streamlined an expanded access program and fully covers the cost of the drug for people who qualify for the program. (A phone number is provided for more information.) Additionally, the company is studying the benefits of thalidomide treatment for oral and esophageal aphthous ulcers. Results from the use of three different doses following four weeks will be compared, after which patients will be randomly assigned to either a placebo or thalidomide to determine its ability to prevent a relapse. Because of thalidomide's connection to serious birth defects, it is important that men and women engaging in reproductive sex use precautions to prevent pregnancy.^ieng

Thalidomide: new expanded access for wasting.

AIDS: The Food and Drug Administration (FDA) has authorized thalidomide in an expanded-access program for AIDS-related wasting. The New Jersey program will randomize patients to either 50 or 200 mg doses. Response will be measured after four weeks; those failing the lower dose can switch to the higher dose at that time. Patients may continue therapy indefinitely. Treatment cost may be up to $1,000 per year. Physicians will need to obtain IRB approval to participate. Those who are excluded are pregnant women or those of childbearing age, those involved in a separate double-blind controlled trial of thalidomide which is still recruiting, and those with peripheral neuropathy or major blood chemistry abnormalities. For more information, call (800) 896-6766, or, after September 4th, call (800) 253-1596.^ieng

Expanded access for experimental AIDS drugs.

AIDS: Descriptions and entry criteria for three expanded access programs for experimental drugs used in treating AIDS patients are provided. The programs involve use of Abbott Laboratories' protease inhibitor, ritonavir; Hoffman-La Roche's protease inhibitor, saquinavir; and Celgene Corporation's treatment for wasting, thalidomide.^ieng