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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

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ClinicalTrials.gov Identifier: NCT01361165
Recruitment Status : Completed
First Posted : May 26, 2011
Last Update Posted : May 26, 2011
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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:

  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.

Condition or disease
HIV-Infected Children

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:

  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.

Study Design
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Observational
Estimated Enrollment : 10 participants
Official Title: Data Analysis for 04-C-0234 Tenofovir Disoproxil Fumarate Salvage Therapy in HIV-Infected Children and a Study of Its Effect on Bone Metabolism
Study Start Date : September 2006
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   Child, Adult, Senior
Accepts Healthy Volunteers:   No
Criteria
  • Data Analysis Only
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01361165


Locations
United States, Maryland
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT01361165     History of Changes
Other Study ID Numbers: 999906255
06-C-N255
First Posted: May 26, 2011    Key Record Dates
Last Update Posted: May 26, 2011
Last Verified: May 2011

Keywords provided by National Institutes of Health Clinical Center (CC):
Pediatric
Data Analysis

Additional relevant MeSH terms:
Tenofovir
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents