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United States Department of Agriculture

Agricultural Research Service

Related Topics

Research Project: Atn 109 and Atn 117 Sample Repository and Laboratory Studies

Location: Immunity and Disease Prevention Research Unit

2013 Annual Report


1a.Objectives (from AD-416):
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.


1b.Approach (from AD-416):
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.


3.Progress Report:

This research relates to objective 1 of the inhouse project, “Conduct a controlled, vitamin D supplementation trial in volunteers with vitamin D insufficiency (VDI) to determine if supplementation to achieve the proposed level of >75 nmol/L for maintenance of bone health is also appropriate for maintenance of immune function". The project has continued into a new phase this year. ARS scientists at the Davis, California, location, are collaborating on two new studies funded via the agreement with scientists from the University of Alabama at Birmingham, and other scientists in the Adolescent Trials Network (ATN). 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. ARS Scientists are co-investigators on these studies and are performing laboratory work but are not directly involved in the clinical aspects of the studies. Both studies began recruiting volunteers during the present funding period and recruitment will continue throughout the year.


Last Modified: 11/26/2014
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