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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00615563
First received: January 31, 2008
Last updated: May 14, 2008
Last verified: May 2008
History of Changes
  Purpose

The primary objective of this trial is to assess the presence of resistance to tipranavir and other ARVs of the HIV-1 isolates in treatment experienced patients. The secondary objective of this study is to examine clinicians? use of HIV drug resistance testing in treatment experienced patients currently failing a PI based HAART regimen. Ideally resistance testing will help clinicians identify active/sensitive ARVs needed to construct a rescue HAART regimen.


Condition Intervention Phase
HIV Infections
 Behavioral: NO BI Drug administered
 Phase 4

Study Type: Observational
Official Title: Utilization of HIV Drug Resistance Testing in Treatment Experienced Patients (UTILIZE Study)

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • The primary endpoint is the level of sensitivity of a patient?s HIV 1 isolate to tipranavir. Co primary endpoints are the levels of sensitivity of a patient?s HIV 1 isolate to other marketed ARVs (PIs, NRTIs, and NNRTIs).

Secondary Outcome Measures:
  • a) Protease inhibitor(s) identified by the clinician prior to resistance testing to which a patient?s HIV 1 virus is thought to be susceptible. b) PI that was discontinued or initiated after receiving resistance testing results.

Estimated Enrollment: 260
Estimated Study Completion Date: January 2008
  Eligibility

Ages Eligible for Study:   18 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

Patients that meet the following inclusion criteria will be eligible for participation in this study:

  1. Signed patient informed consent prior to study participation.
  2. HIV-1 infected male or female ?18 years of age.
  3. Have confirmed (2 consecutive) HIV RNA ?1000 copies/mL (one of the results must be within 3 months of enrollment into the study).
  4. Current HAART regimen contains a protease inhibitor for ?3 months.
  5. 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:

  1. ARV medication naive.
  2. Active opportunistic infection. c.) Known or suspected non-adherence to current HAART regimen as assessed by the investigator.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00615563

  Show 36 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator B.I. Pharmaceuticals,Inc./Ridgefield
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00615563     History of Changes
Other Study ID Numbers: 1182.116
Study First Received: January 31, 2008
Last Updated: May 14, 2008
Health Authority: United States of America: Food and Drug Administration

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on May 19, 2013