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

The HIV Netherlands Australia Thailand Research Collaboration24 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Masking

NONE

Enrollment

Conditions

HIV-1 Infections

Interventions

lopinavir/ritonavirOTHER

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

Eligibility

Sex: ALLMin age: 1 YearMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

HIV-NAT

Bangkok, Thailand

Outcomes

Primary Outcomes

assess the level of lopinavir trough level >1 mg/L in low dose lopinavir (reduction by 70%)

study drug Aluvia (lopinavir/ritonavir 100/25 mg)

Time frame: 4 months

Data from ClinicalTrials.gov

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