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Lopinavir (LPV) Dose Reduction

NCT01159275 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-07-17

No results posted yet for this study

Summary

The purpose of this study is to study the pharmacokinetics profiles of generic lopinavir/ritonavir and Pediatric Aluvia® at reduced dose by assessing safety, tolerability and efficacy.

Conditions

  • HIV-1 Infections

Interventions

DRUG

Generic LPV/r and Aluvia (pharmacokinetics)

Generic LPV/r 200/50 mg BID 12 hr PK then cross over to Pediatric Aluvia 200/50 mg BID

DRUG

Aluvia and Generic LPV/r (pharmacokinetics)

First Pediatric Aluvia® 200/50 mg BID, then cross over to Generic LPV/r 200/50 mg BID

Sponsors & Collaborators

  • Ministry of Education, Thailand

    collaborator OTHER

  • The HIV Netherlands Australia Thailand Research Collaboration

    lead OTHER

Principal Investigators

  • Anchalee Avihingsanon, MD · The HIV Netherlands Australia Thailand Research Collaboration

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2010-03-31
Completion
2010-03-31

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 NCT01159275 on ClinicalTrials.gov