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NCT00088309 · ClinicalTrials.gov registry record · Phase 2
Effect of Tenofovir DF on Bone Metabolism in Children
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
NCT00088309: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00088309 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 50 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00088309, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
Study Summary
This study will examine the long-term effects, particularly on bone metabolism, of the drug tenofovir DF in children with HIV infection. Tenofovir DF is approved for treating HIV-infected adults, but its use in children has not yet been approved. The drug may be helpful for children who have been treated with many other drugs and still have detectable HIV in their blood despite ongoing therapy. In a previous study, many children given tenofovir DF responded well, with increases in T-cell counts and decreases in viral load. However, many children also experienced bone thinning. This study will explore the problem of bone thinning in children taking tenofovir DF in combination with highly active antiretroviral therapy (HAART). HIV-infected patients from 4 to 20 years old who are taking tenofovir DF or for whom tenofovir DF treatment has been recommended may be eligible for this 3-year study. Participants take tenofovir DF every day in addition to their antiretroviral therapy. They have frequent follow-up visits for tests and procedures as follows: * Study days 0, 2, and 4: blood tests. * Screening and every study visit starting day 6: Physical exam, medical history, blood and urine tests. * Baseline and every 48 weeks: Dental and eye examinations, kidney ultrasound, tuberculin skin testing, chest x-ray, electrocardiogram and echocardiogram, computed tomography (CT) scan, neuropsychological testing and neurologic assessment. * The bone age hand x-rays are done every 24 weeks, unless the growth plates are fused (i.e. the child has stopped growing) * DEXAs are done at 0, 12, 24 weeks and every 24 weeks thereafter. Dual energy x-ray absorptionometry (DEXA) scan is used to assess bone density. The patient lies still on a table while the spine and hip are scanned using a small amount of radiation. Only the spine and hip are scanned in the DEXA scan test. * Baseline and week 24: Optional bone biopsy. Some patients are asked to undergo a bone biopsy to better understand th
Interventions
- PROCEDURE Electrocardiogram
- PROCEDURE CT scan
- PROCEDURE Eye exam
- PROCEDURE Oral exam
- PROCEDURE Neuropsychological testing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2004-06 |
| Est. Completion | 2006-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00088309
The ClinicalTrials.gov registry entry for NCT00088309 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Electrocardiogram is the first listed.
NCT00088309 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00088309 about?
NCT00088309 is a clinical study titled "Effect of Tenofovir DF on Bone Metabolism in Children". This study will examine the long-term effects, particularly on bone metabolism, of the drug tenofovir DF in children with HIV infection. Tenofovir DF is approved for treating HIV-infected adults, but its use in children has not yet been approved. The drug may be helpful for children who have been tr...
What is the current status of trial NCT00088309?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2004-06. Estimated completion is 2006-05.
What interventions are being tested in trial NCT00088309?
The interventions under investigation include: Electrocardiogram (PROCEDURE), CT scan (PROCEDURE), Eye exam (PROCEDURE), Oral exam (PROCEDURE), Neuropsychological testing (PROCEDURE).
Who is sponsoring clinical trial NCT00088309?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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