Lopinavir/Ritonavir (LPV/r) Tablet in HIV Infected Children

Phase 2

Completed

• Conditions: HIV-1 Infections
• Interventions: Other: lopinavir/ritonavir

• Registration Number: NCT01139905
• Lead Sponsor: The HIV Netherlands Australia Thailand Research Collaboration

Brief Summary

To study the pharmacokinetics of low-dose lopinavir/ritonavir tablet in HIV-1 infected Thai children.

Detailed Description

This is an open-label, single arm study to compare standard dose with a new tablet formulation of a lower dose of lopinavir/ritonavir in HIV-1 infected children.

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-06-04
• Study First Submitted QC: 2010-06-08
• Study First Posted: 2010-06-09
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-24
• Last Update Posted: 2015-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. HIV infection
2. Age < 18 years old
3. BW > 25 kg
4. HIV RNA viral load < 50 copies within 6 months
5. Written informed consent

Exclusion Criteria

1. Active opportunistic infection
2. Relevant history or current condition, illness that might interfere with drug absorption, distribution, metabolism or excretion.
3. Use of concomitant medications that may interfere with the pharmacokinetics of lopinavir/ritonavir

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	lopinavir/ritonavir	standard dose of lopinavir/ritonavir 100/25 mg tablet q 12 hour

Primary Outcome Measures

Name	Time	Method
assess the level of lopinavir trough level >1 mg/L in low dose lopinavir (reduction by 70%)	4 months	study drug Aluvia (lopinavir/ritonavir 100/25 mg)

Trial Locations

Locations (1)

HIV-NAT; 🇹🇭 Bangkok, Thailand