Trial Information

Data Analysis for 04-C-0234 Tenofovir Disoproxil Fumarate Salvage Therapy in HIV-Infected Children and a Study of Its Effect on Bone Metabolism

We plan to analyze the data to meet the primary objective of the study:

To characterize the change in bone mineral density (BMD), as measured by lumbar spine DEXA,
during and following treatment with tenofovir DF-containing antiretroviral therapy in
HIV-infected children.

In addition, we plan to analyze the data to meet 2 secondary objectives of the study:

1. To study and monitor markers of bone metabolism - calcium, phosphorus, parathyroid
hormone (PTH), vitamin D levels, bone resorption markers (urinary collagen cross-linked
N-telopeptide and free deoxypyridinoline), bone formation markers (bone specific
alkaline phosphatase and osteocalcin) - in HIV-infected children treated with tenofovir
DF-containing antiretroviral therapy.

2. To study immunologic, virologic and clinical effects of tenofovir DF administered to
HIV-infected children in combination with other antiretroviral therapies.