In The Works

The latest news about AIDS research and ongoing clinical studies

Serono Sponsors Trials

Serono Laboratories, Norwell, MA, is sponsoring a large, multi-center, placebo-controlled trial of Serostim for HIV wasting. Patients will be randomized to receive 6 mg daily, 6 mg every other day or placebo for 12 weeks. Then, patients will be re-randomized to receive either Serositm 6 mg daily or 6 mg every other day for 36 weeks. Study participants will be monitored for body composition and exercise tolerance (on a bicycle) at the end of 12 weeks. For more information call .

Caloric Supplements Face Off

Nestle Clinical Nutrition, Deerfield, IL, is sponsoring an open-label, randomized, three-arm comparative trial of a caloric supplement with peptides and medium-chain triglycerides, versus a caloric supplement with whole protein and long-chain triglycerides, versus no supplement for the prevention of weight loss in individuals with AIDS who take a daily multivitamin and mineral supplement. The former two groups will take Peptamen drinks and NuBasics drinks respectively, at a rate of two 250 mL cans per day, plus a multivitamin and mineral supplement and basic meals. The company is seeking 683 patients, or 228 in each of its study arms. Patients will be measured for percent change in weight from baseline after four months. Secondary outcomes being monitored include: percent change in body cell mass from baseline to four months measured by Bioelectrical Impedance Analysis, permanent discontinuation of study for any reason, and caloric intake measured by 24-hour dietary recall.

Research From the Edge

The Cutting Edge, a consulting firm in Cary, IL, has three HIV-related studies in the pipeline. The company is looking for sites to study exocrine pancreatic function in HIV-positive patients taking protease inhibitors. The research will be performed in conjunction with a British study. The Cutting Edge was recently awarded money for a study on development and field testing of standards of care in nutritional management of HIV-positive pediatric patients. That study is scheduled to last three years, and will be performed with Mary Ryan, M.D., a physician at St. Francis Hospital in San Francisco. The third study will collect data on body composition changes in HIV-positive adults taking protease inhibitor cocktails. The BIA testing will be observational and will be performed where the procedure is available.

New in New York

Dr. Don Kotler, medical director of the GI Immunology Center at St. Luke's Roosevelt Hospital, New York City, reports that he is planning two studies of thalidomide. One will compare thalidomide and growth hormone in patients with active disease, such as tuberculosis. The other will examine the effect of thalidomide on body composition.

In addition, one of Kotler's students plans to analyze the effect of protein supplements on muscle strength and body composition in HIV-positive women.