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NCT00615563 Clinical Trial

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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00615563
Other study ID # 1182.116
Secondary ID
Status Completed
Phase Phase 4
First received January 31, 2008
Last updated November 20, 2013
Start date March 2007
Est. completion date January 2008

Study information
Verified date November 2013
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority United States of America: Food and Drug Administration
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 246
Est. completion date January 2008
Est. primary completion date January 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 18 Years
Eligibility 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Behavioral:
• NO BI Drug administered

Locations
Country Name City State
Puerto Rico Boehringer Ingelheim Investigational Site Ponce
Puerto Rico Boehringer Ingelheim Investigational Site Ponce
United States Boehringer Ingelheim Investigational Site Akron Ohio
United States Boehringer Ingelheim Investigational Site Bakersfield California
United States Boehringer Ingelheim Investigational Site Baltimore Maryland
United States Boehringer Ingelheim Investigational Site Berkley Michigan
United States Boehringer Ingelheim Investigational Site Beverly Hills California
United States Boehringer Ingelheim Investigational Site Camden New Jersey
United States Boehringer Ingelheim Investigational Site Charlotte North Carolina
United States Boehringer Ingelheim Investigational Site Chicago Illinois
United States Boehringer Ingelheim Investigational Site Dallas Texas
United States Boehringer Ingelheim Investigational Site Daytona Beach Florida
United States Boehringer Ingelheim Investigational Site Fort Worth Texas
United States Boehringer Ingelheim Investigational Site Fountain Valley California
United States Boehringer Ingelheim Investigational Site Ft. Lauderdale Florida
United States Boehringer Ingelheim Investigational Site Ft. Lauderdale Florida
United States Boehringer Ingelheim Investigational Site Hampton Virginia
United States Boehringer Ingelheim Investigational Site Houston Texas
United States Boehringer Ingelheim Investigational Site Huntersville North Carolina
United States Boehringer Ingelheim Investigational Site Los Angeles California
United States Boehringer Ingelheim Investigational Site Los Angeles California
United States Boehringer Ingelheim Investigational Site Miami Florida
United States Boehringer Ingelheim Investigational Site Miami Florida
United States Boehringer Ingelheim Investigational Site New Orleans Louisiana
United States Boehringer Ingelheim Investigational Site Newark New Jersey
United States Boehringer Ingelheim Investigational Site Newark New Jersey
United States Boehringer Ingelheim Investigational Site Newport Beach California
United States Boehringer Ingelheim Investigational Site North Palm Beach Florida
United States Boehringer Ingelheim Investigational Site Oakland California
United States Boehringer Ingelheim Investigational Site Pensacola Florida
United States Boehringer Ingelheim Investigational Site Portland Oregon
United States Boehringer Ingelheim Investigational Site Rochester New York
United States Boehringer Ingelheim Investigational Site Springfield Massachusetts
United States Boehringer Ingelheim Investigational Site St. Louis Missouri
United States Boehringer Ingelheim Investigational Site Stanford California
United States Boehringer Ingelheim Investigational Site Voorhees New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome
Type Measure Description Time frame Safety issue
Primary Level of sensitivity of a patient's HIV-1 isolate to tipranavir Day 1 No
Primary Levels of sensitivity of a patient's HIV-1 isolate to other marketed ARVs (PIs, NRTIs, and NNRTIs). Day 1 No
Secondary 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 Day 1 No
Secondary PI that was discontinued or initiated after receiving resistance testing results up to 45 days No
Secondary Non-PI ARVs that were discontinued or initiated after receiving resistance testing results up to 45 days No
Secondary Rationale reported for modifying or not modifying baseline ARV regimen after receiving resistance testing results up to 45 days No
Secondary Utilization (yes/no) of expert interpretation by a clinician after receiving resistance testing results up to 45 days No
Secondary Relationship between prior number of PIs utilized and number of available (sensitive) PIs as determined by resistance testing up to 45 days No
Secondary The physician's assessment of whether the phenotypic testing (as part of combined testing) provided more information than the genotypic test alone did up to 45 days No
Secondary Physician reported limitations that influence access to resistance testing day 1 No
Secondary Clinician reported reasons why tipranavir was or was not considered as an option for each patient up to 45 days No
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