Safety, efficacy and immunological evaluation of a polyherbal formulation against HIV-AIDS in an open-label clinical trial

Abstract

HIV/AIDS is one of the worst pandemics the world has ever witnessed. With 2 million deaths occurring every year, the battle with HIV is far from over. Highly Active Anti-Retroviral Therapy (HAART) is highly effective, with current regimens largely addressing the problems associated with toxicity and side effects. HAART, however, is not accessible to all the populations in the world due to high costs as well as availability. In addition, HAART is not effective in all the patients, in terms of virologic control, immune reconstitution and reduction of immune activation. Owing to this failure of HAART, mortality incidence in HIV infection is still higher as compared to that of the general population. Incidence of non-AIDS related complications such as cardio-vascular disease and liver dysfunction are on the increase, despite successful HAART. What is currently needed is a selective immunomodulator that can function in conjunction with HAART and suppress post-HAART residual immune activation. Traditional herbal medicines are an attractive source of such immunomodulators. Alternative medicines have been widely used by HIV-infected people. However, their safety and efficacy against HIV/AIDS has not been studied in a systematic manner. Several studies suffer from methodological and reporting limitations and there is no conclusive evidence as of date, that alternative medicines possess a beneficial effect against HIV/AIDS.