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Data Analysis for 04-C-0234 Tenofovir Disoproxil Fumarate Salvage Therapy in HIV-Infected Children and a Study of Its Effect on Bone Metabolism

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01361165
First Posted: May 26, 2011
Last Update Posted: May 26, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institutes of Health Clinical Center (CC)
May 24, 2011
May 26, 2011
May 26, 2011
September 2006
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No Changes Posted
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Data Analysis for 04-C-0234 Tenofovir Disoproxil Fumarate Salvage Therapy in HIV-Infected Children and a Study of Its Effect on Bone Metabolism
Data Analysis for 04-C-0234 Tenofovir Disoproxil Fumarate Salvage Therapy in HIV-Infected Children and a Study of Its Effect on Bone Metabolism

We plan to analyze the data to meet the primary objective of the study:

To characterize the change in bone mineral density (BMD), as measured by lumbar spine DEXA, during and following treatment with tenofovir DF-containing antiretroviral therapy in HIV-infected children.

In addition, we plan to analyze the data to meet 2 secondary objectives of the study:

  1. To study and monitor markers of bone metabolism - calcium, phosphorus, parathyroid hormone (PTH), vitamin D levels, bone resorption markers (urinary collagen cross-linked N-telopeptide and free deoxypyridinoline), bone formation markers (bone specific alkaline phosphatase and osteocalcin) - in HIV-infected children treated with tenofovir DF-containing antiretroviral therapy.
  2. To study immunologic, virologic and clinical effects of tenofovir DF administered to HIV-infected children in combination with other antiretroviral therapies.

We plan to analyze the data to meet the primary objective of the study:

To characterize the change in bone mineral density (BMD), as measured by lumbar spine DEXA, during and following treatment with tenofovir DF-containing antiretroviral therapy in HIV-infected children.

In addition, we plan to analyze the data to meet 2 secondary objectives of the study:

  1. To study and monitor markers of bone metabolism - calcium, phosphorus, parathyroid hormone (PTH), vitamin D levels, bone resorption markers (urinary collagen cross-linked N-telopeptide and free deoxypyridinoline), bone formation markers (bone specific alkaline phosphatase and osteocalcin) - in HIV-infected children treated with tenofovir DF-containing antiretroviral therapy.
  2. To study immunologic, virologic and clinical effects of tenofovir DF administered to HIV-infected children in combination with other antiretroviral therapies.
Observational
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HIV-Infected Children
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
October 2008
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  • Data Analysis Only
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Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01361165
999906255
06-C-N255
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National Cancer Institute (NCI)
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National Institutes of Health Clinical Center (CC)
May 2011