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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00615563
First received: January 31, 2008
Last updated: November 20, 2013
Last verified: November 2013
  Purpose

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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Utilization of HIV Drug Resistance Testing in Treatment Experienced Patients (UTILIZE Study)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Level of sensitivity of a patient's HIV-1 isolate to tipranavir [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Levels of sensitivity of a patient's HIV-1 isolate to other marketed ARVs (PIs, NRTIs, and NNRTIs). [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • PI that was discontinued or initiated after receiving resistance testing results [ Time Frame: up to 45 days ] [ Designated as safety issue: No ]
  • Non-PI ARVs that were discontinued or initiated after receiving resistance testing results [ Time Frame: up to 45 days ] [ Designated as safety issue: No ]
  • Rationale reported for modifying or not modifying baseline ARV regimen after receiving resistance testing results [ Time Frame: up to 45 days ] [ Designated as safety issue: No ]
  • Utilization (yes/no) of expert interpretation by a clinician after receiving resistance testing results [ Time Frame: up to 45 days ] [ Designated as safety issue: No ]
  • Relationship between prior number of PIs utilized and number of available (sensitive) PIs as determined by resistance testing [ Time Frame: up to 45 days ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Physician reported limitations that influence access to resistance testing [ Time Frame: day 1 ] [ Designated as safety issue: No ]
  • Clinician reported reasons why tipranavir was or was not considered as an option for each patient [ Time Frame: up to 45 days ] [ Designated as safety issue: No ]

Enrollment: 246
Study Start Date: March 2007
Estimated Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
genotype test Behavioral: NO BI Drug administered
combined phenotype/genotype test Behavioral: NO BI Drug administered

  Eligibility

Ages Eligible for Study:   18 Years to 18 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00615563

  Show 36 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
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: November 20, 2013
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 April 20, 2014