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

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ClinicalTrials.gov Identifier: NCT00615563
Recruitment Status : Completed
First Posted : February 14, 2008
Last Update Posted : November 21, 2013
Sponsor:
Information provided by:
Boehringer Ingelheim

Study Description
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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 examine clinicians' use of HIV drug resistance testing in treatment experienced patients currently failing a PI based HAART regimen.

Condition or disease Intervention/treatment
HIV Infections Behavioral: NO BI Drug administered

Study Design
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Study Type : Observational
Actual Enrollment : 246 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Utilization of HIV Drug Resistance Testing in Treatment Experienced Patients (UTILIZE Study)
Study Start Date : March 2007
Actual Primary Completion Date : January 2008
Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

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

Groups and Cohorts
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Group/Cohort Intervention/treatment
genotype test Behavioral: NO BI Drug administered
combined phenotype/genotype test Behavioral: NO BI Drug administered


Outcome Measures
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Primary Outcome Measures :
  1. Level of sensitivity of a patient's HIV-1 isolate to tipranavir [ Time Frame: Day 1 ]
  2. Levels of sensitivity of a patient's HIV-1 isolate to other marketed ARVs (PIs, NRTIs, and NNRTIs). [ Time Frame: Day 1 ]

Secondary Outcome Measures :
  1. Protease inhibitor(s) (PI) identified by the clinician prior to resistance testing to which a patient's HIV-1 virus was thought to be susceptible [ Time Frame: Day 1 ]
  2. PI that was discontinued or initiated after receiving resistance testing results [ Time Frame: up to 45 days ]
  3. Non-PI ARVs that were discontinued or initiated after receiving resistance testing results [ Time Frame: up to 45 days ]
  4. Rationale reported for modifying or not modifying baseline ARV regimen after receiving resistance testing results [ Time Frame: up to 45 days ]
  5. Utilization (yes/no) of expert interpretation by a clinician after receiving resistance testing results [ Time Frame: up to 45 days ]
  6. Relationship between prior number of PIs utilized and number of available (sensitive) PIs as determined by resistance testing [ Time Frame: up to 45 days ]
  7. The physician's assessment of whether the phenotypic testing (as part of combined testing) provided more information than the genotypic test alone did [ Time Frame: up to 45 days ]
  8. Physician reported limitations that influence access to resistance testing [ Time Frame: day 1 ]
  9. Clinician reported reasons why tipranavir was or was not considered as an option for each patient [ Time Frame: up to 45 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 18 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Primary care clinic
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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00615563


  Show 36 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator B.I. Pharmaceuticals,Inc./Ridgefield
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00615563     History of Changes
Other Study ID Numbers: 1182.116
First Posted: February 14, 2008    Key Record Dates
Last Update Posted: November 21, 2013
Last Verified: November 2013

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