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

Pharmacokinetics of Low- Dose Lopinavir/Ritonavir Tablet Formulation HIV-1 Infected Children

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01139905

Enrollment

Registered

2010-06-09

Start date

2010-04-30

Completion date

2011-03-31

Last updated

2015-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV-1 Infections

Keywords

Lopinavir/ritonavir, pharmacokinetic, low dose, HIV-infected children, pharmacokinetics of low-dose lopinavir/ritonavir in HIV-1 infected Thai children.

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.

Interventions

OTHERlopinavir/ritonavir

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Years to 18 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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)

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026