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Evaluation of Therapeutic Drug Monitoring of Protease Inhibitors on Virologic Success and Tolerance of Highly Active Antiretroviral Therapy (HAART)

NCT00122590 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2005-08-01

No results posted yet for this study

Summary

This Cophar2 study is a trial which evaluates repeated early therapeutic drug monitoring, from weeks 2 to 24, after the initiation of HAART including either indinavir/r, lopinavir/r or the new 625 mg formulation of nelfinavir twice-a-day (bid). If trough concentrations were out of the range given for each protease inhibitor (PI), the PI dose was adjusted.

Conditions

  • HIV Infections

Interventions

DRUG

nelfinavir

DRUG

lopinavir/r

DRUG

indinavir

DRUG

ritonavir

Sponsors & Collaborators

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • French National Agency for Research on AIDS and Viral Hepatitis

    lead OTHER_GOV

Principal Investigators

  • Dominique Salmon, MD · Service de Medecine Interne Hopital Cochin Paris

  • France Mentre, MD · Inserm EMI 03 57

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-07-31
Completion
2005-03-31

Countries

  • France

Study Locations

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Entities

Companies

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 NCT00122590 on ClinicalTrials.gov