IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. 
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:
National Cancer Institute (NCI)
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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| Ages Eligible for Study: | Child, Adult, Senior |
| Accepts Healthy Volunteers: | No |
Criteria
- Data Analysis Only
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01361165
Please refer to this study by its ClinicalTrials.gov identifier: NCT01361165
Locations
| United States, Maryland | |
| National Cancer Institute (NCI) | |
| Bethesda, Maryland, United States, 20892 | |
Sponsors and Collaborators
National Cancer Institute (NCI)
More Information
| 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 |
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 |
ClinicalTrials.gov processed this record on July 21, 2017