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

Completed

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00615563

Run by

Boehringer Ingelheim

People needed

246

Starts

2007-03-01

Expected to finish

2008-01-01

Last updated by the study team

2013-11-21

Who can join

Age: 18 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients that meet the following inclusion criteria will be eligible for participation in this study:
• Signed patient informed consent prior to study participation.
• HIV-1 infected male or female ?18 years of age.
• Have confirmed (2 consecutive) HIV RNA ?1000 copies/mL (one of the results must be within 3 months of enrollment into the study).
• Current HAART regimen contains a protease inhibitor for ?3 months.
• 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.

You may not qualify if…

• A patient with any of the following criteria will be excluded from participation in the study:
• ARV medication naive.
• Active opportunistic infection. c.) Known or suspected non-adherence to current HAART regimen as assessed by the investigator.

Where it is running

• Boehringer Ingelheim Investigational Site — Bakersfield, California, United States
• Boehringer Ingelheim Investigational Site — Beverly Hills, California, United States
• Boehringer Ingelheim Investigational Site — Fountain Valley, California, United States
• Boehringer Ingelheim Investigational Site — Los Angeles, California, United States
• Boehringer Ingelheim Investigational Site — Los Angeles, California, United States
• Boehringer Ingelheim Investigational Site — Newport Beach, California, United States
• Boehringer Ingelheim Investigational Site — Oakland, California, United States
• Boehringer Ingelheim Investigational Site — Stanford, California, United States
• Boehringer Ingelheim Investigational Site — Daytona Beach, Florida, United States
• Boehringer Ingelheim Investigational Site — Fort Lauderdale, Florida, United States
• Boehringer Ingelheim Investigational Site — Fort Lauderdale, Florida, United States
• Boehringer Ingelheim Investigational Site — Miami, Florida, United States
• Boehringer Ingelheim Investigational Site — Miami, Florida, United States
• Boehringer Ingelheim Investigational Site — North Palm Beach, Florida, United States
• Boehringer Ingelheim Investigational Site — Pensacola, Florida, United States
• Boehringer Ingelheim Investigational Site — Chicago, Illinois, United States
• Boehringer Ingelheim Investigational Site — New Orleans, Louisiana, United States
• Boehringer Ingelheim Investigational Site — Baltimore, Maryland, United States
• Boehringer Ingelheim Investigational Site — Springfield, Massachusetts, United States
• Boehringer Ingelheim Investigational Site — Berkley, Michigan, United States
• Boehringer Ingelheim Investigational Site — St Louis, Missouri, United States
• Boehringer Ingelheim Investigational Site — Camden, New Jersey, United States
• Boehringer Ingelheim Investigational Site — Newark, New Jersey, United States
• Boehringer Ingelheim Investigational Site — Newark, New Jersey, United States
• Boehringer Ingelheim Investigational Site — Voorhees Township, New Jersey, United States

Full record on ClinicalTrials.gov

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