Utilization of HIV Drug Resistance Testing in Treatment Experienced Patients (UTILIZE Study)
- NCT00615563
- Not Specified
- OBSERVATIONAL
Last updated: 2013-11-21
Purpose of Trial
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.
This study is for people with
HIV Infections
Interventions being studied
NO BI Drug administered
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.
ELIGIBILITY
Gender: ALL
Age: 18+
Healthy Volunteers: No
34 Locations
Bakersfield
Boehringer Ingelheim Investigational Site
California, 93301, United States
Beverly Hills
Boehringer Ingelheim Investigational Site
California, 90211, United States
Fountain Valley
Boehringer Ingelheim Investigational Site
California, 92708, United States
Los Angeles
Boehringer Ingelheim Investigational Site
California, 90028, United States
Los Angeles
Boehringer Ingelheim Investigational Site
California, 90069, United States
Newport Beach
Boehringer Ingelheim Investigational Site
California, 92663, United States
Oakland
Boehringer Ingelheim Investigational Site
California, 94609, United States
Stanford
Boehringer Ingelheim Investigational Site
California, 94305-5107, United States
Daytona Beach
Boehringer Ingelheim Investigational Site
Florida, 32117, United States
Ft. Lauderdale
Boehringer Ingelheim Investigational Site
Florida, 33308, United States
Ft. Lauderdale
Boehringer Ingelheim Investigational Site
Florida, 33316, United States
Miami
Boehringer Ingelheim Investigational Site
Florida, 33133, United States
Miami
Boehringer Ingelheim Investigational Site
Florida, 33137, United States
North Palm Beach
Boehringer Ingelheim Investigational Site
Florida, 33408, United States
Pensacola
Boehringer Ingelheim Investigational Site
Florida, 32504, United States
Chicago
Boehringer Ingelheim Investigational Site
Illinois, 60613, United States
New Orleans
Boehringer Ingelheim Investigational Site
Louisiana, 70121, United States
Baltimore
Boehringer Ingelheim Investigational Site
Maryland, 21201, United States
Springfield
Boehringer Ingelheim Investigational Site
Massachusetts, 01107, United States
Berkley
Boehringer Ingelheim Investigational Site
Michigan, 48072, United States
St. Louis
Boehringer Ingelheim Investigational Site
Missouri, 63139, United States
Camden
Boehringer Ingelheim Investigational Site
New Jersey, 08103, United States
Newark
Boehringer Ingelheim Investigational Site
New Jersey, 07102, United States
Newark
Boehringer Ingelheim Investigational Site
New Jersey, 07103, United States
Voorhees
Boehringer Ingelheim Investigational Site
New Jersey, 08043, United States
Rochester
Boehringer Ingelheim Investigational Site
New York, 14604, United States
Charlotte
Boehringer Ingelheim Investigational Site
North Carolina, 28209, United States
Huntersville
Boehringer Ingelheim Investigational Site
North Carolina, 28078, United States
Akron
Boehringer Ingelheim Investigational Site
Ohio, 44304, United States
Portland
Boehringer Ingelheim Investigational Site
Oregon, 97209, United States
Dallas
Boehringer Ingelheim Investigational Site
Texas, 75246, United States
Fort Worth
Boehringer Ingelheim Investigational Site
Texas, 76104, United States
Houston
Boehringer Ingelheim Investigational Site
Texas, 77004, United States
Hampton
Boehringer Ingelheim Investigational Site
Virginia, 23666, United States
Primary Contact(s)
Boehringer Ingelheim
Data obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Learn more at
ClinicalTrials.gov