Data Analysis for 04-C-0234 Tenofovir Disoproxil Fumarate Salvage Therapy in HIV-Infected Children and a Study of Its Effect on Bone Metabolism
NCT ID: NCT01361165
Last Updated: 2023-10-31
Study Results
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Basic Information
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COMPLETED
10 participants
OBSERVATIONAL
2006-09-30
2008-10-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Eligibility Criteria
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Inclusion Criteria
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Locations
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National Cancer Institute (NCI)
Bethesda, Maryland, United States
Countries
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Other Identifiers
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06-C-N255
Identifier Type: -
Identifier Source: secondary_id
999906255
Identifier Type: -
Identifier Source: org_study_id
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