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

The HIV Netherlands Australia Thailand Research Collaboration

Status and phase: Completed; Phase 2

Conditions: HIV-1 Infections

Treatments: Other: lopinavir/ritonavir

Study type: Interventional

Funder types: Other

Identifiers

NCT01139905

HIV-NAT 100

Details and patient eligibility

About

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

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

24 participants in 1 patient group

1

Other group

Description:

standard dose of lopinavir/ritonavir 100/25 mg tablet q 12 hour

Treatment:

Other: lopinavir/ritonavir