Data Analysis for 04-C-0234 Tenofovir Disoproxil Fumarate Salvage Therapy in HIV-Infected Children and a Study of Its Effect on Bone Metabolism
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01361165 |
Recruitment Status
:
Completed
First Posted
: May 26, 2011
Last Update Posted
: May 26, 2011
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 or disease |
---|
HIV-Infected Children |
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 : | 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 |


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, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Senior |
Accepts Healthy Volunteers: | No |
- Data Analysis Only

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
United States, Maryland | |
National Cancer Institute (NCI) | |
Bethesda, Maryland, United States, 20892 |
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 |