IMPAACT P1063: Safety and Effectiveness of Atorvastatin in HIV Infected Children and Adolescents With Hyperlipidemia
Status:
Terminated
Trial end date:
2014-12-01
Target enrollment:
Participant gender:
Summary
Treatment of HIV with combination antiretroviral regimens frequently results in the
suppression of HIV viral load, significant immune recovery, and delayed disease progression.
However, treatment with these regimens, particularly protease inhibitors (PIs), has been
associated with significant increases in cholesterol and triglycerides in HIV-infected adults
and children. The purpose of this study was to evaluate the safety and effectiveness of
escalating doses of atorvastatin, a FDA-approved drug which lowers cholesterol and
triglyceride levels, in HIV-infected children receiving stable antiretroviral regimens.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Institute of Allergy and Infectious Diseases (NIAID)