Atazavanir/Ritonavir-based HAART in Children

• Status: Completed
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

Summary

There are no data on efficacy, safety and pharmacokinetics of ATV/r-based HAART in HIV-infected Asian children. Therefore, the investigators aim to evaluate the pharmacokinetics, efficacy and safety of ATV/r-based HAART in Thai HIV-infected children.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The HIV Netherlands Australia Thailand Research Collaboration
• Collaborators: amfAR, The Foundation for AIDS Research; National Health Security Office, Thailand; The Thai Government Pharmaceutical Organization (GPO)
• Treatments: Atazanavir Sulfate; Ritonavir

Criteria

Inclusion Criteria:

1. HIV-infected children

2. Age from 6- 18 years old

3. Body weight ≥ 25 kg at screening visit

4. ARV history, the children can be categorized in one of these 2 groups

5. ALT <200 IU/L at screening visit

6. Total bilirubin < 3 mg/dL at the screening visit

7. Can swallow capsule

8. Written informed consent from caregivers and assent (from children aged 7-17 years who know their HIV status)

Exclusion Criteria:

1. Active opportunistic infection

2. Relevant history or current condition, illness that might interfere with atazanavir/ritonavir absorption, distribution, metabolism or excretion.

3. Use of concomitant medication that may interfere with the pharmacokinetics of ATV/r (i.e. efavirenz, indinavir, proton pump inhibitor, antacids, cisapride, clarithromycin, rifampin etc.)

4. Pregnancy or lactating at screening visit

5. Liver diseases e.g. hepatitis B carrier, chronic hepatitis, cirrhosis

6. Inability to understand the nature and extent of the study and the procedures required.