Safety of Saquinavir and High Doses of Lopinavir/Ritonavir in Children With HIV

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the effect of increased doses of lopinavir/ritonavir (LPV/r) and saquinavir (SQV) in HIV infected children who are failing their current antiretroviral regimen

• 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: Lopinavir; Ritonavir; Saquinavir

Criteria

Inclusion Criteria:

• HIV infected

• HIV RNA viral load greater than 5,000 copies/ml

• At least 6 months of continuous therapy with a protease inhibitor (PI) prior to study entry

• No change in antiretroviral therapy since genotypic resistance testing

• Genotypic resistance testing indicating a primary protease mutation at position 32, 47, 48, 50, 82, or 84 and at least three other mutations in positions 10, 20, 24, 30, 32, 33, 36, 46, 47, 48, 50, 53, 54, 71, 73, 77, 82, 84, or 90 OR phenotypic resistance testing, within 6 months of screening while on a failing regimen, indicating at least a fivefold increase in LPV as compared to wild type HIV

• Parent or legal guardian willing to provide informed consent

• If sexually active, agree to use acceptable methods of contraception

• Have a telephone, pager, or other method of reliable communication with study staff

• Able and willing to swallow study medications

Exclusion Criteria:

• Any drug toxicity greater than Grade 3 at screening

• Certain abnormal laboratory values

• Acute opportunistic or serious bacterial infection requiring treatment

• Chemotherapy for active cancer

• Any significant diseases (other than HIV infection) that may, in the opinion of the investigator, interfere with the study

• Require certain medications

• History of heart problems

• Family history of prolonged QTc-Interval Syndrome or prolonged QTc-interval at study entry

• Pregnancy or breastfeeding