Safety, Tolerability, and Anti-HIV Activity of DMP 266 (Efavirenz) in Combination With Nelfinavir in HIV-Positive Children
Status:
Completed
Trial end date:
2002-12-01
Target enrollment:
Participant gender:
Summary
Cohort I: The purpose of this study is to see how safe it is to combine 2 anti-HIV
medications, efavirenz (EFZ) and nelfinavir (NFV) to treat HIV-positive children and to find
an appropriate dose of EFZ to use in combination with NFV. Cohort II: The purpose of this
study is to see how safe it is to give EFZ syrup combined with NFV and to measure the levels
of EFZ and NFV in the blood. (This purpose reflects a change from the original since there
are now 2 different cohorts of patients.) EFZ is an effective anti-HIV medication that easily
can be combined with other drugs to treat HIV. This is an early study to determine a safe and
effective dose for HIV-positive children. This study also will examine the correct dose of
NFV to use in combination with EFZ.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)