Status:
COMPLETED
Effect of Tenofovir DF on Bone Metabolism in Children
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
HIV Infections
Eligibility:
All Genders
Phase:
PHASE2
Brief 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 ...
Detailed Description
Tenofovir disoproxil fumarate (TDF) was approved for the treatment of HIV-infected adults in October 2001. In November 2001, we began enrollment to our phase I/II study of tenofovir DF in HIV-infected...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA: Cohort 1 - patients about to start tenofovir DF
- HIV-infected children between the ages of 4 years and less than 21 years.
- Clinical decision has been made to start the patient on tenofovir DF-containing antiretroviral regimen
- BSA greater than or equal to 0.85 m2
- Sexually active patients must be willing to use a medically acceptable form of birth control, which includes abstinence, while they are being treated on this study.
- Not pregnant or breast feeding
- 25-OH-Vitamin D level greater than 20 ng/ml (supplementation allowed)
- Less than or equal to grade 1 serum calcium or ionized calcium (supplementation allowed)
- AST and ALT less than or equal to 7.5 times the upper limit of normal
- Age-adjusted normal serum creatinine OR a creatinine clearance greater than or equal to 70 mL/min/1.73.
- Informed consent: patient, parent or legal guardian must sign the study informed consent to document their understanding of the investigational nature and the risks of the study before any protocol-related studies are performed.
- INCLUSION CRITERIA: Cohort 2 - patients already being treated with tenofovir DF who have baseline DEXA available
- HIV-infected children between the ages of 4 years and less than 21 years.
- Current tenofovir DF-containing antiretroviral regimen was started less than 6 months ago
- Baseline DEXA for L-spine BMD is available and was performed less than six months prior to or within the first week of starting tenofovir DF
- BSA greater than or equal to 0.85 m2
- Sexually active patients must be willing to use a medically acceptable form of birth control, which includes abstinence, while they are being treated on this study.
- Not pregnant or breast feeding
- 25-OH-Vitamin D level greater than 20 ng/ml (supplementation allowed)
- Less than or equal to grade 1 serum calcium or ionized calcium (supplementation allowed)
- AST and ALT less than or equal to 7.5 times the upper limit of normal
- Age-adjusted normal serum creatinine OR a creatinine clearance greater than or equal to 70 mL/min/1.73.
- Informed consent: patient, parent or legal guardian must sign the study informed consent to document their understanding of the investigational nature and the risks of the study before any protocol-related studies are performed.
- INCLUSION CRITERIA: Cohort 3 - patients already being treated with an antiretroviral regimen that includes tenofovir DF who DO NOT have baseline DEXA available
- HIV-infected children between the ages of 4 years and less than 21 years.
- Current antiretroviral regimen includes tenofovir DF
- Baseline (within prior 6 months) DEXA for L-spine BMD is NOT available
- BSA greater than or equal to 0.85 m2
- Sexually active patients must be willing to use a medically acceptable form of birth control, which includes abstinence, while they are being treated on this study.
- Not pregnant or breast feeding
- 25-OH-Vitamin D level greater than 20 ng/ml (supplementation allowed)
- less than or equal to grade 1 serum calcium or ionized calcium (supplementation allowed)
- AST and ALT less than or equal to 7.5 times the upper limit of normal
- Age-adjusted normal serum creatinine (see table below) OR a creatinine clearance greater than or equal to 70 mL/min/1.73.
- Informed consent: patient, parent or legal guardian must sign the study informed consent to document their understanding of the investigational nature and the risks of the study before any protocol-related studies are performed.
- INCLUSION CRITERIA: Eligibility criteria for pamidronate therapy (after enrollment on protocol)
- One of the following while on tenofovirDF-containing antiretroviral regimen:
- Greater than 6% loss in L-spine BMD in the presence of a BMD Z score less than -2.5 at 6 months compared to baseline
- Minimal trauma fracture
- BMD Z-score less than -3
- AND
- One of the following while on tenofovirDF-containing antiretroviral regimen:
- Greater than or equal to 0.5 log decrease in VL from baseline
- Greater than or equal to 25% increase in absolute CD4 count from baseline
- Improvement in HIV-related signs or symptoms
- OR
- BMD Z-score less than -3 (i.e., pamidronate therapy will also be considered for subjects whose BMD Z score is less than -3 at baseline)
- Age-adjusted normal serum creatinine (see table below) OR a creatinine clearance greater than or equal to 70 mL/min/1.73.
- Less than or equal to grade 1 serum phosphate, magnesium, and potassium (supplementation allowed)
- Not pregnant or breast feeding
- No history of hypersensitivity to bisphosphonates
- INCLUSION CRITERIA: Eligibility criteria for bone biopsy (after enrollment on protocol)
- No history of bleeding abnormality
- No history of hypersensitivity or intolerance to tetracycline or related drugs
- Normal CBC and PT/PTT
- BMD Z-score greater than -3
- Informed consent: patient, parent or legal guardian must sign a separate informed consent to document their understanding of the investigational nature and the risks of the bone biopsy.
Exclusion
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
End Date :
May 1 2006
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00088309
Start Date
June 1 2004
End Date
May 1 2006
Last Update
March 4 2008
Active Locations (1)
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1
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892