ATN 109 and ATN 117 Sample Repository and Laboratory Studies
Immunity and Disease Prevention Research Unit
Project Number: 2032-53000-001-02
Start Date: Aug 01, 2011
End Date: Feb 28, 2015
Vitamin D deficiency causes loss of bone mineral density by impairing calcium and phosphate absorption. Vitamin D metabolisms and bone mineralization can be disrupted during HIV infection by a variety of factors, including use of the antiretroviral drug tenofovir. This project represents a collaboration between ARS scientists from the Western Human Nutrition Research Center (WHNRC) and scientists of the Adolescent Trials Network (ATN) to conduct two studies. The first study, ATN109, is titled “A Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Effectiveness of Vitamin D3 50,000 IU Every 4 weeks to Increase Bone Mineral Density and Decrease Tenofovir-Induced Hyperparathyroidism in Youth with HIV Infection Being Treated with Tenofovir-Containing Combination Antiretroviral Therapy”. The second study, ATN117, is titled “Renal, endocrine, and bone changes in response to treatment with coformulated tenofovir-emtricitabine for pre-and-post-exposure HIV prophylaxis (PrEP) in HIV uninfected young men who have sex with men in the United States. Sub study of ATN 110 and ATN 113”. Both studies are multi-center studies sponsored by The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The studies are coordinated by the University of Alabama at Birmingham. In addition, samples are also being stored from the already completed ATN063 study, which will be utilized for analysis of markers of inflammation.
WHNRC scientists are co-investigators on these ATN studies and are performing laboratory work and maintaining a repository of biological specimens from these studies for later analysis at the WHNRC. Laboratory studies will include analysis of vitamin D metabolites, calcium, phosphate, markers of bone metabolism and kidney function, as well as markers of endocrine function and inflammation. Data analysis will be performed with research collaborators who are part of the ATN network and are located at a Westat, University of Alabama at Birmingham, Medical College of Wisconsin, University of California, San Francisco and other institutions.