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

January 31, 2008
November 20, 2013
March 2007
January 2008   (final data collection date for primary outcome measure)
  • 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 ]
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). [ Time Frame: Days 1-17 ]
Complete list of historical versions of study NCT00615563 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Protease inhibitor(s) identified by the clinician prior to resistance testing to which a patient?s HIV 1 virus is thought to be susceptible. [ Time Frame: 18 to 45 Days ]
  • PI that was discontinued or initiated after receiving resistance testing results. [ Time Frame: 18 to 45 days ]
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Utilization of HIV Drug Resistance Testing in Treatment Experienced Patients (UTILIZE Study)
Utilization of HIV Drug Resistance Testing in Treatment Experienced Patients (UTILIZE Study)

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

Primary care clinic

HIV Infections
Behavioral: NO BI Drug administered
  • genotype test
    Intervention: Behavioral: NO BI Drug administered
  • combined phenotype/genotype test
    Intervention: Behavioral: NO BI Drug administered
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
246
January 2008
January 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00615563
1182.116
Not Provided
Not Provided
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Study Coordinator B.I. Pharmaceuticals,Inc./Ridgefield
Boehringer Ingelheim
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP