Effect of Tenofovir DF on Bone Metabolism in Children

You may be eligible if

• 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.
• 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.
• 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.
• 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
• 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.