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:

Information provided by:

National Institutes of Health Clinical Center (CC)

ClinicalTrials.gov Identifier:

NCT01361165

First received: May 24, 2011

Last updated: NA

Last verified: May 2011

History: No changes posted

Tracking Information
First Received Date ^ICMJE	May 24, 2011
Last Updated Date	May 24, 2011
Start Date ^ICMJE	September 2006
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Data Analysis for 04-C-0234 Tenofovir Disoproxil Fumarate Salvage Therapy in HIV-Infected Children and a Study of Its Effect on Bone Metabolism
Official Title ^ICMJE	Data Analysis for 04-C-0234 Tenofovir Disoproxil Fumarate Salvage Therapy in HIV-Infected Children and a Study of Its Effect on Bone Metabolism
Brief Summary	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: 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. To study immunologic, virologic and clinical effects of tenofovir DF administered to HIV-infected children in combination with other antiretroviral therapies.
Detailed Description	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: 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. To study immunologic, virologic and clinical effects of tenofovir DF administered to HIV-infected children in combination with other antiretroviral therapies.
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Not Provided
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Not Provided
Study Population	Not Provided
Condition ^ICMJE	HIV-Infected Children
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	10
Completion Date	October 2008
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	Data Analysis Only
Gender	Not Provided
Ages	Not Provided
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01361165
Other Study ID Numbers ^ICMJE	999906255, 06-C-N255
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	National Cancer Institute (NCI)
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	National Institutes of Health Clinical Center (CC)
Verification Date	May 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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