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
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Purpose
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.
| Condition |
|---|
|
HIV-Infected Children |
| Study Type: | Observational |
| 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 |
Resource links provided by NLM:
Further study details as provided by National Institutes of Health Clinical Center (CC):
| Estimated Enrollment: | 10 |
| Study Start Date: | September 2006 |
| Study Completion Date: | October 2008 |
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.
Eligibility| Accepts Healthy Volunteers: | No |
Criteria
- Data Analysis Only
Contacts and Locations More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT01361165 History of Changes |
| Other Study ID Numbers: | 999906255, 06-C-N255 |
| Study First Received: | May 24, 2011 |
| Last Updated: | May 24, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institutes of Health Clinical Center (CC):
|
Pediatric Data Analysis |
Additional relevant MeSH terms:
|
Tenofovir Tenofovir disoproxil Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents |
ClinicalTrials.gov processed this record on May 16, 2013