Lopinavir/Ritonavir Monotherapy in Children

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy (clinical, immunological, virological outcome), pharmacokinetics and safety of lopinavir/ritonavir (LPV/r) monotherapy maintenance in Thai children after viral load suppression with double boosted protease inhibitors (PIs).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The HIV Netherlands Australia Thailand Research Collaboration
• Collaborators: Chulalongkorn University; Khon Kaen University
• Treatments: Lopinavir; Ritonavir

Criteria

Inclusion Criteria:

1. HIV infected children ages 2 to 18 years

2. Treated with double boosted PIs during the last three months

3. Two consecutive plasma HIV-RNA levels < 50 copies/ml at least 3 months apart

4. Willing to restart HAART with the same regimen as before enrollment, when indicated

5. Signed written informed consent

Exclusion Criteria:

1. Active AIDS-defining disease at screening

2. Pregnancy