Protocol of Determining the Effect of Vimang® and Spirel® Supplementation in Aids Patients with Delayed Diagnosis of HIV: An Open Randomized Controlled Trial

Abstract

Background: Infection by Human immunodeficiency virus (VIH) constitutes a world health problem. The antiretroviral therapy accordingly recent WHO recommendation is proposed for all HIV seropositive individuals. Treatment optimization is encouraged due to certain risk of toxic adverse effects and resistance. The use of antioxidants has been indicated as a plausible option in these patients indeed pre or post exposition to antiretroviral treatment. Methods: In an open randomized control trial, 170 aids delayed diagnosis patients whose received prescription of High active antiretroviral therapy (HAART) will selected to be covered under Hospital-IPK monitoring consults (Cuban Referral HIV/aids Research Centre). Patients will be randomised to receive 10 mL of Vimang® aqueous extract twice a day or Spirel® tablets (400 mg) three times a day or only HAART, but all groups will consume HAART during 12 months. The baseline assessment of the patients who meet the inclusion criteria includes doing some lab tests to determine the absolute count of CD4+ T lymphocyte, viral load, chemical, haematological and seven plasma redox indexes. Both, opportunistic infection and adverse reaction occurrence will be reported during the monthly visits in the first six months of the follow-up and at the end of the 12th month. For evaluating the effect of both products concomitant to antiretroviral all variables will be measured in the final follow-up session and compared with the baseline value. Also quality of life interview, physical activity and dietary questionnaires will be assessed at pre and post study period in the three groups.