Utilization of HIV Drug Resistance Testing in Treatment Experienced Patients (UTILIZE Study) - Full Text View

Sponsored by:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00615563

Purpose

The primary objective of this trial is to assess the presence of resistance to tipranavir and other ARVs of the HIV-1 isolates in treatment experienced patients. The secondary objective of this study is to examine clinicians? use of HIV drug resistance testing in treatment experienced patients currently failing a PI based HAART regimen. Ideally resistance testing will help clinicians identify active/sensitive ARVs needed to construct a rescue HAART regimen.

Condition	Intervention	Phase
HIV Infections	Behavioral: NO BI Drug administered	Phase IV

MedlinePlus related topics: AIDS

U.S. FDA Resources

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

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

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).

Secondary Outcome Measures:

a) Protease inhibitor(s) identified by the clinician prior to resistance testing to which a patient?s HIV 1 virus is thought to be susceptible. b) PI that was discontinued or initiated after receiving resistance testing results.

Estimated Enrollment:	260
Estimated Study Completion Date:	January 2008

Eligibility

Ages Eligible for Study:	18 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria

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.

Exclusion criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00615563

Show 36 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim Study Coordinator

B.I. Pharmaceuticals,Inc./Ridgefield

More Information

Study ID Numbers:	1182.116
Study First Received:	January 31, 2008
Last Updated:	May 14, 2008
ClinicalTrials.gov Identifier:	NCT00615563
Health Authority:	United States of America: Food and Drug Administration

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 14, 2009