Blood Levels of Anti-HIV Drugs Used in Combination Regimens in HIV Infected Children

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Limited data exist about combination anti-HIV treatment regimens in children, including how those drugs are cleared by the body in children. The purpose of this study is to measure the blood levels of the following combinations of anti-HIV drugs in HIV infected chilren: tenofovir disoproxil fumurate (TDF) and efavirenz (EFV) or nevirapine (NVP); TDF and darunavir (DRV) with or without EFV; and TDF and ritonavir (RTV) with or without EFV.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: Atazanavir Sulfate; Darunavir; Efavirenz; Nevirapine; Ritonavir; Tenofovir

Criteria

Note: The original Groups A, B, and C have been removed, and Groups D, E, and F have been added per protocol amendment dated 11/16/07.

Inclusion Criteria:

• HIV infected

• Currently receiving or about to initiate one of the following anti-HIV regimens: TDF with EFV or NVP, TDF and DRV/r with or without EFV, or TDF with ATV/r with or without EFV

• Body surface area at least 0.85 m2

• Parent or guardian willing and able to provide signed informed consent

• Willing to use acceptable forms of contraception

Exclusion Criteria:

• Liver disease that may affect the metabolism of study drugs

• Certain abnormal laboratory values

• Require certain medications

• Treatment with any anti-HIV or nonantiretroviral drug that could interact with drugs under PK study in the 14 days prior to study entry

• Any clinical or laboratory toxicity of Grade 4 or higher at screening. More information on this criterion can be found in the protocol.

• Pregnant or breastfeeding