Tesamorelin Clinical Trial Reports Successful Reduction Of Fat Accumulation In HIV Patients
Tesamorelin, a growth hormone-releasing compound, successfully reduced abdominal fat in HIV-positive subjects by approximately 18 percent, according to a new study published in the Journal of Acquired Immune Deficiency Syndromes (JAIDS).
Excess abdominal fat accumulation, also called lipohypertrophy, is one of the potential side effects of antiretroviral therapy (ART). Tesamorelin, a new drug candidate, may be able to counteract this common problem among HIV patients.
The clinical trial took place over 12 months among 404 HIV-positive individuals with excess abdominal fat as a result of ART. Some patients were given a placebo, and some received tesamorelin.
Patients receiving the drug saw their belly profiles improve and also reported an improved body image. No significant side effects or disruption of blood sugar levels were reported.
However, researchers also noted that the improvements were lost when patients stopped taking tesamorelin after six months.
Theratechnologies, which is developing tesamorelin, reported recently that a meeting with the United States Food and Drug Administration (FDA) to review the drug has been delayed until July. The review is a necessary step in the drug approval process.
This delay is due to a rescheduling of the FDA’s Metabolic Drugs Advisory Committee to May 27 and is unrelated to tesamorelin itself.
For more information, please see the study at the JAIDS Web site (abstract) or related AIDS Beacon articles about the new drug application for tesamorelin and the rescheduled FDA review.
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