Ritonavir and Indinavir in Children Failing Other Anti-HIV Treatment

• Status: Completed
• Trial end date: 2005-07-01
• Target enrollment: 0
• Participant gender: All

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
• 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: Indinavir; Ritonavir

Criteria

Inclusion Criteria

• HIV infection

• HIV RNA levels > 10,000 copies/ml within 30 days prior to study entry

• Anti-HIV drug therapy failure while on the same anti-HIV drugs for more than 16 weeks

• Body size above a certain limit (body surface area > 0.48 m2)

• Acceptable methods of contraception

• Consent of parent or legal guardian

Exclusion Criteria

• Unable to determine HIV genotypic resistance

• HIV resistant to IDV or RTV at study screening

• Previously received IDV and RTV at the same time

• Need treatment with any medication prohibited by the study

• Glucocorticoids for more than 14 days at study entry

• Cancer requiring chemotherapy

• Drugs affecting the immune system, other than IVIG, within 3 months of study entry

• Certain abnormal laboratory results at study entry

• Pregnant or breast-feeding

• Unable to be followed at a PACTG center during the trial