NAPWA

A possible new treatment for excessive abdominal fat associated with HIV-related lipodystrophy was presented at IAS 2008. Dr Julian Falutz, from Montreal General Hospital reported that treatment with tesamorelin, which sparks the production of natural growth hormone, resulted in a significant loss of deep belly fat compared with a placeboA dummy medical treatment, designed to have no pharmacological effect, administered to the control group of a clinical trial. dose in people with lipodystrophy in results from the first half of a Phase IIIA large clinical trial designed to establish whether a drug is effective and safe enough for widespread use. Phase III studies include expanded controlled and uncontrolled trials after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug and provide and adequate basis for physician labeling. clinicalPertaining to or founded on observation and treatment of participants, as distinguished from theoretical or basic science. trialA clinical trial is a research study to answer specific questions about vaccines or new therapies or new ways of using known treatments. Clinical trials are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people. Trials are in four phases: Phase I tests a new drug or treatment in a small group; Phase II expands the study to a larger group of people; Phase III expands the study to an even larger group of people; and Phase IV takes place after the drug or treatment has been licensed and marketed. .

Those who received tesamorelin had a 10.9 percent decrease in deep belly fat compared with 0.6 percent decrease in those who received a placebo. This is thought to be a significant difference. The volume of fat directly below the skin increased by an average of 1.1 percent in the tesamorelin group and 0.9 in the placebo group. Falutz reported that treatment with tesamorelin increased lean body mass and decreased deep belly fat without impacting on limb fat.

Falutz J, et al. Results from the 26-week confirmatory, Phase 111 trial of tesamorelin (TH9507), a growth hormone-releasing factor analogue, in HIV patients with excess abdominal fat: A multi-centre, double-blindA clinical trial design in which neither the participating individuals nor the study staff knows which participants are receiving the experimental drug and which are receiving a placebo (or another therapy). Double-blind trials are thought to produce objective results, since the expectations of the doctor and the participant about the experimental drug do not affect the outcome; also called double-masked study., placebo-controlledA method of investigation of drugs in which an inactive substance (the placebo) is given to one group of participants, while the drug being tested is given to another group. The results obtained in the two groups are then compared to see if the investigational treatment is more effective in treating the condition. study with 404 randomisedA method based on chance by which study participants are assigned to a treatment group. Randomization minimizes the differences among groups by equally distributing people with particular characteristics among all the trial arms. The researchers do not know which treatment is better. From what is known at the time, any one of the treatments chosen could be of benefit to the participant patients. 17th International AIDS Conference, Mexico City. Abstract Poster LBPE1156, 2008