Effect of Tenofovir DF on Bone Metabolism in Children
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Drug Resistance, HAART, Pamidronate, Osteopenia, Pediatric, HIV, Pediatrics, Treatment Experienced
Eligibility Criteria
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.
Sites / Locations
- National Cancer Institute (NCI)