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A PK and Salvage Study for Children With HIV-infection

NCT00476359 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2015-03-27

No results posted yet for this study

Summary

To evaluate the pharmacokinetics (PK) of LPV/r with saquinavir in HIV-1 infected children. To evaluate treatment response (clinical, immunological and virological) to LPV/r, SQV in Thai children.

Conditions

  • HIV Infections

Interventions

DRUG

Lopinavir/r plus saquinavir

lopinavir/ritonavir 230/57.5 mg/m2 orally twice daily and saquinavir 50 mg/kg orally twice daily

Sponsors & Collaborators

  • Roche for trial and Saquinavir,and Abbott for Kaletra

    collaborator UNKNOWN

  • The HIV Netherlands Australia Thailand Research Collaboration

    lead OTHER

Principal Investigators

  • Kiat Ruxrungtham, MD · HIV-NAT, Bangkok, Thailand

  • Pope Kosalaraksa, MD · Khon Kaen University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-10-31
Primary Completion
2008-11-30
Completion
2008-11-30

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 NCT00476359 on ClinicalTrials.gov