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

Purpose

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.

Condition	Intervention	Phase
HIV Infections	Behavioral: NO BI Drug administered	Phase 4


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Utilization of HIV Drug Resistance Testing in Treatment Experienced Patients (UTILIZE Study)

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]


Enrollment:	246
Study Start Date:	March 2007
Estimated Study Completion Date:	January 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
genotype test	Behavioral: NO BI Drug administered
combined phenotype/genotype test	Behavioral: NO BI Drug administered

Eligibility


Ages Eligible for Study:	18 Years to 18 Years (Adult)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Primary care clinic

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Show 36 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim

Investigators


Study Chair:	Boehringer Ingelheim Study Coordinator	B.I. Pharmaceuticals,Inc./Ridgefield

More Information


ClinicalTrials.gov Identifier:	NCT00615563 History of Changes
Other Study ID Numbers:	1182.116
Study First Received:	January 31, 2008
Last Updated:	November 20, 2013
Health Authority:	United States of America: Food and Drug Administration

Additional relevant MeSH terms:


HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases	Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases

ClinicalTrials.gov processed this record on September 27, 2016