Effect of Tenofovir DF on Bone Metabolism in Children

Inclusion Criteria

• •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.