Adjunct Vitamin A Therapy for Tuberculosis and HIV/AIDS

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DESCRIPTION (provided by applicant): Tuberculosis is one of the leading causes of mortality worldwide, accounting for an estimated three million deaths annually. Micronutrient deficiencies are common during HIV infection and during pulmonary tuberculosis, and micronutrient deficiencies are associated with impaired immunity and increased morbidity and mortality. Despite adequate chemotherapy for tuberculosis, the morbidity and mortality of HIV-infected adults with pulmonary tuberculosis remains extremely high. The goal of this ongoing Phase III randomized, double-blind, controlled clinical trial is to determine whether a daily multivitamin (vitamins and minerals) supplement can reduce morbidity and mortality of HIV-infected adults with pulmonary tuberculosis in Malawi. All participants receive standard tuberculosis chemotherapy for eight months as per the Malawi National Tuberculosis Control Programme, and the total duration of follow-up in the trial is twenty-four months. The trial has a Community Advisory Board which consists of local community members and participants. The original sample size of the trial was reduced to 500 HIV-infected adults in order to complete enrollment within the study period and deal with a budget reduction. Interim analyses conducted for the NIAID HIV Therapeutic Clinical Trials Data and Safety Monitoring Board (DSMB) at NIH show that the trial has been conducted with steady enrollment, good adherence to supplementation, and high follow-up. The DSMB has recommended that the sample size of this trial be increased to have at least 80% power to detect a 20% reduction in mortality. To meet this recommendation, we propose to increase the sample size to 840 HIV-infected adults with pulmonary tuberculosis. The trial also includes 300 HIV-negative adults with pulmonary tuberculosis in order to reduce stigmatization. If this study demonstrates that a multivitamin supplement can reduce morbidity and mortality of HIV-infected adults with pulmonary tuberculosis, this appropriate, low cost intervention could be integrated with tuberculosis treatment to improve health and survival of HIV-infected individuals in developing countries.