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Lopinavir/Ritonavir Monotherapy in Children

NCT00626301 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2015-03-26

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy (clinical, immunological, virological outcome), pharmacokinetics and safety of lopinavir/ritonavir (LPV/r) monotherapy maintenance in Thai children after viral load suppression with double boosted protease inhibitors (PIs).

Conditions

  • HIV Infections

Interventions

DRUG

LPV/r

LPV/r 230/57.5 mg/m2 orally q12h or the adjusted dose based on therapeutic drug monitoring of LPV/r prior to enrollment as maintenance monotherapy

Sponsors & Collaborators

  • Chulalongkorn University

    collaborator OTHER

  • Khon Kaen University

    collaborator OTHER

  • The HIV Netherlands Australia Thailand Research Collaboration

    lead OTHER

Principal Investigators

  • Praphan Phanuphak, MD, PhD · HIV-NAT, Thai Red Cross - AIDS Research Centre

  • Pope Kosalaraksa, MD · Department of Pediatrics, Khon Kaen University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2009-09-30
Completion
2009-09-30

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00626301 on ClinicalTrials.gov