Safety and Effectiveness of Lopinavir/Ritonavir in HIV Infected Infants

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to find out if the drug lopinavir/ritonavir (LPV/RTV) is safe and well tolerated in HIV infected infants. This study will also determine the most effective dose of LPV/RTV for infants.

• Phase: Phase 1
• 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: Lopinavir; Ritonavir

Criteria

Inclusion Criteria

• HIV infected

• Viral load greater than 10,000 copies/ml within 30 days prior to study entry

• Weigh more than 5.5 lbs at the time of enrollment

• Agree to take 2 nucleoside reverse transcriptase inhibitors (NRTIs) in addition to LPV/RTV

• Have consent of parent or guardian willing to provide signed informed consent and to have the infant followed at a PACTG site

Exclusion Criteria

• Currently taking a nonnucleoside reverse transcriptase inhibitor or protease inhibitor (PI) while on study

• Previously used LPV/RTV. Patients who were treated previously with other PIs are not excluded. Prior or concurrent maternal treatment with LPV/RTV is not excluded.

• For patients less than 6 weeks old at time of enrollment, less than 34 weeks gestation at delivery OR for patients 6 or more weeks old at time of enrollment, less than 32 weeks gestation at delivery

• Any laboratory toxicity of Grade 3 or greater. Hyperlipasemia of Grade 2 or higher is also excluded.

• Newly diagnosed acute opportunistic or serious bacterial infection requiring therapy at the time of enrollment

• Chemotherapy for active cancer

• Certain medications

• Any other clinically significant conditions, other than HIV infection, that would interfere with the study