Ritonavir and Indinavir in Children Failing Other Anti-HIV Treatment
Status:
Completed
Trial end date:
2005-07-01
Target enrollment:
Participant gender:
Summary
Both ritonavir (RTV) and indinavir (IDV) are approved by the FDA to treat HIV, but IDV has
not been approved for use in children and the doses for the combination of the two drugs has
not been studied in children. The purpose of this study is to find a combination of RTV and
IDV that is safe, well tolerated, and produces drug levels in the blood of children that are
comparable to effective drug levels in the blood of adults. The effectiveness of the drug
combination in decreasing the amount of virus in the body will also be studied. The children
enrolled in this study will have high HIV viral loads despite taking anti-HIV drugs.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)