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Status:

COMPLETED

Utilization of HIV Drug Resistance Testing in Treatment Experienced Patients (UTILIZE Study)

Lead Sponsor:

Boehringer Ingelheim

Conditions:

HIV Infections

Eligibility:

All Genders

18-18 years

Brief Summary

The primary objective of this trial was to assess the presence of susceptibility to tipranavir and other ARVs of the HIV-1 isolates in treatment experienced patients. The secondary objective was to ex...

Eligibility Criteria

Inclusion

  • Inclusion criteria
  • Patients that meet the following inclusion criteria will be eligible for participation in this study:
  • Signed patient informed consent prior to study participation.
  • HIV-1 infected male or female ?18 years of age.
  • Have confirmed (2 consecutive) HIV RNA ?1000 copies/mL (one of the results must be within 3 months of enrollment into the study).
  • Current HAART regimen contains a protease inhibitor for ?3 months.
  • Physicians considering a change in the patient?s HAART regimen. f.) History of treatment with 2 or more protease inhibitors (including the current PI). Low dose ritonavir (i.e.\< 400 mg. bid) is not counted as one of the PIs.
  • Exclusion criteria
  • A patient with any of the following criteria will be excluded from participation in the study:
  • ARV medication naive.
  • Active opportunistic infection. c.) Known or suspected non-adherence to current HAART regimen as assessed by the investigator.

Exclusion

    Key Trial Info

    Start Date :

    March 1 2007

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    January 1 2008

    Estimated Enrollment :

    246 Patients enrolled

    Trial Details

    Trial ID

    NCT00615563

    Start Date

    March 1 2007

    End Date

    January 1 2008

    Last Update

    November 21 2013

    Active Locations (36)

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    Page 1 of 9 (36 locations)

    1

    Boehringer Ingelheim Investigational Site

    Bakersfield, California, United States, 93301

    2

    Boehringer Ingelheim Investigational Site

    Beverly Hills, California, United States, 90211

    3

    Boehringer Ingelheim Investigational Site

    Fountain Valley, California, United States, 92708

    4

    Boehringer Ingelheim Investigational Site

    Los Angeles, California, United States, 90028