Pediatric Study for Appropriate Dose of Ritonavir Boosted Lopinavir in Thai HIV-infected Children (PEARL)

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

Summary

To compare the safety and efficacy of low-dose versus standard dose lopinavir/ritonavir containing HAART regimen in virological suppress, HIV RNA viral load < 50 copies/ml at 48 week

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The HIV Netherlands Australia Thailand Research Collaboration
• Collaborators: Bamrasnaradura Infectious Diseases Institute; Buddhachinaraj Hospital; Chulalongkorn University; Nakornping Hospital; Phrachomklao Hospital; Prapokklao Hospital; Queen Sirikit National Institute of Child Health; Sappasitthiprasong Hospital; Srinagarind Hospital, Khon Kaen University; Surin Hospital; Udonthani Hospital
• Treatments: Lopinavir; Ritonavir

Criteria

Inclusion Criteria:

1. HIV infection children age < 18 years old

2. Currently on PI regimens

3. HIV RNA viral load < 50 copies/ml at screening

4. BW 25-50 kg

5. Written informed consent

Exclusion Criteria:

1. Relevant history or current condition of PI resistance, plasma HIV RNA > 1000 copies/ml after received the PI regimens for at least 6 months

2. On rifampin, nevirapine, efavirenz which have drug interaction with lopinavir

3. On double boosted protease inhibitors