MedTrace Logo

Data Analysis for 04-C-0234 Tenofovir Disoproxil Fumarate Salvage Therapy in HIV-Infected Children and a Study of Its Effect on Bone Metabolism

NCT01361165 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 10

Last updated 2023-10-31

No results posted yet for this study

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.

Conditions

  • HIV-Infected Children

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-30
Completion
2008-10-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01361165 on ClinicalTrials.gov