Researchers have been advancing towards an innovative breakthrough in the HIV treatment. This breakthrough comes with a synthetic human growth hormone factor. A synthetic human growth hormone-releasing factor has significant beneficial effects on ‘lipid profiles and visceral obesity in patients with HIV-associated lipodystrophy’.
Ongoing clinical trials divided in to phased testing’s have revealed various other findings in addition to this breakthrough. Results from a phase III trial show that there is an analogy between the new factor and typical characteristics observed in the HIV patients.
The researchers explained about this new finding that, “Tesamorelin“is a synthetic human growth hormone releasing factor GHRH (1-44) analogue with a trans-3-hexenoyl group added to the N-terminal to increase the half-life over that of native GHRH (1-44)”.
The study involving phased clinical trials with selected HIV patients is underway at the McGill University Health Centre, in Montreal, Canada under the leadership of Dr.Julian Falutz. Concurrent findings and investigation reports of this study have also been published in the “New England Journal of Medicine”.
This clinical trial based study was intended to test if this factor might correct the dyslipidemia, visceral adiposity, and excess cardiovascular disease associated with anti-retroviral therapy. In order to reach at some conclusive findings level the researchers randomly assigned 412 patients with HIV and visceral adiposity to a daily subcutaneous injection of tesamorelin 2 mg or placebo.
All these 412 patients with HIV and visceral adiposity were followed for 26 weeks continuously. Researchers observed that after 26 weeks, visceral adipose tissue mass had decreased 15.2% in those given tesamorelin and increased by 5% in those given placebo.
Researchers explained that “Tesamorelin” was associated with a 50-mg/dl decrease in triglyceride concentrations, compared with an increase of 9 mg/dl in placebo-treated patients. Active treatment also significantly improved the patients’ ratios of total to high-density lipoprotein cholesterol, whereas placebo had no effect.
The study results demonstrated that the adverse event rate was the same for tesamorelin and placebo, although more patients stopped taking tesamorelin treatment than placebo because of an adverse event.
Lead author Julian Falutz is of the view that, “If this second clinical study is as conclusive as the first, there is hope that patients will have tesamorelin available as a treatment option for HIV-associated lipodystrophy within the next couple of years“.
Julian Falutz from McGill University Health Centre, in Montreal, Canada, said that a confirmatory trial is in progress.
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