A clinical trial on the efficacy of IMOD in AIDS patients

Abstract

Background and the purpose of the study:

Following the phase I clinical trial of the herbal drug IMOD^TM in HIV/AIDS patients, further studies were required to assess the drug efficacy and side effects. Therefore its safety and efficacy in HIV infected patients in a phase II were examined, and clinical trial phase III were designed.

Methods:This study was conducted in three stages. In the first stage six patients who were resistant to highly active anti retroviral therapy (HAART) regimen were chosen and offered therapy with Setarud. Subsequently another group of 27 patients with CD4 count less than 350 but without AIDS defining criteria were enrolled to the study and randomly assigned to intervention. In the third stage a double-center randomized clinical trial was conducted at two independent research centers and universities of Iran. Seventy patients were recruited and randomly allocated into groups, called "control" and Setarud groups, using a balanced block randomization method. The main outcome measure was CD4 count. Patients were observed and thoroughly examined (Clinical and laboratory) for six months.

Results:In stages I and II, the mean CD4 count gradually increased within 3 and 6 months intervals. In the stage III the baseline of CD4 counts and other characteristics between two groups were quite similar. The mean increase in CD4 count in Setarud group was about 2-3 fold higher than controls. This effect was much more pronounced in a subgroup of patients with a baseline CD4 count of 200-400 (168 vs. 65, 203 vs. 58, 299 vs. 143 and 285 vs. 109, for time intervals of follow-up, respectively) (p<0.001).

Conclusion:There was a significant improvement in the immune system of HIV patients receiving Setarud therapy by increase in the CD4 count to the higher and more protective level in most subjects. Considering results of the safety tests and reports of the durability of the Setarud effects the use this drug in HIV patients, especially at the pre-AIDS period, as a therapeutic vaccine to slow down the progression of the disease, is recommended.