CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 50 enrolled
Drug / intervention
Lopinavir/r plus saquinavirdrug
Likely dose
Lopinavir/r plus saquinavir 57.5 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00476359
NCT00476359Phase 4Completed
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Lopinavir/r Plus Saquinavir Salvage Therapy in HIV-infected Children With NRTI and/or NNRTI Failure: PK and Two-year Treatment Follow up

The HIV Netherlands Australia Thailand Research Collaboration·interventional·Posted May 22, 2007·Updated Mar 27, 2015

In Brief

A Phase 4 clinical trial evaluating Lopinavir/r plus saquinavir for HIV Infections. Completed, enrolled 50 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesThailand
CollaboratorsRoche for trial and Saquinavir,and Abbott for Kaletra

Timeline

Phase 4CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 22, 2007
Enrollment StartOct 1, 2003
Primary CompletionNov 1, 2008
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 19.1 years ago

Interventions

Lopinavir/r plus saquinavirdrug

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