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2002 SEP 18 - (NewsRx.com & NewsRx.net) -- Indicating for the first time in a clinical trial that Remune might give relief for HIV-infected patients from the adverse side-effects of antiretroviral therapies, The Immune Response Corp. (IMNR) announced results from an ongoing study by the Canadian HIV Trials Network (CTN-140 trial), which examined the effects of stopping HAART (highly active antiretroviral therapy) in adults with chronic HIV infection.
"With the growing number of studies indicating that HIV-infected patients are developing greater resistance and significant adverse side-effects to the battery of antiretroviral drugs available today, the results from this study suggest that treatment strategies using Remune might give their systems the break from drug therapies they need to recover," said Dr. Emil Toma, principal investigator of the trial and a professor at University of Montreal and active staff at Hotel-Dieu du Centre Hospitalier de l'Universite de Montreal (CHUM).
Toma continued, "With this study, we can further develop possible therapeutic approaches designed to give patients a break from antiretrovirals while controlling viral load and boosting the immune system."
The study, conducted over 116 weeks and still ongoing, involved 10 adults with a median age of 41 and ranging from 36-51 years of age. All had chronic HIV infection and were on HAART for a median of 2.7 years, with HIV RNA levels (VL) below detection limit (
After HAART intensification with ddI, GM-CSF, hydroxyurea, and initiation of therapeutic vaccination with Remune, patients stopped antiretrovirals, but continued to receive Remune every 3 months. To date, each participant in the study has received nine doses of Remune.
"In chronically HIV-infected adults, HAART results in significant clinical and immunologic benefits, but even prolonged suppression of HIV replication does not prevent viral rebound when antiretrovirals are stopped," Toma said. "We reasoned that intensification of an already optimal HAART (meaning patients with HIV viral loads below detection limit) with ddI to better fight the HIV in resting cells, hydroxyurea to diminish cell activation and to boost the activity of ddI, GM-CSF to increase the activity of antiretrovirals in reservoirs such as ...
Source: HighBeam Research, The Immune Response Corp. announces results from Remune trial.(Brief...