Clinical trial NCT00615563: Utilization of HIV Drug Resistance Testing in Treatment Experienced Patients (UTILIZE Study)
Official title: Utilization of HIV Drug Resistance Testing in Treatment Experienced Patients (UTILIZE Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2008-02-14
Enrollment: 246
Sex: ALL
Minimum age (years): 18
Maximum age (years): 18
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary care clinic

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Level of sensitivity of a patient's HIV-1 isolate to tipranavir
timeFrame: Day 1
measure: Levels of sensitivity of a patient's HIV-1 isolate to other marketed ARVs (PIs, NRTIs, and NNRTIs).
timeFrame: Day 1
Secondary outcomes:
measure: 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
timeFrame: Day 1
measure: PI that was discontinued or initiated after receiving resistance testing results
timeFrame: up to 45 days
measure: Non-PI ARVs that were discontinued or initiated after receiving resistance testing results
timeFrame: up to 45 days
measure: Rationale reported for modifying or not modifying baseline ARV regimen after receiving resistance testing results
timeFrame: up to 45 days
measure: Utilization (yes/no) of expert interpretation by a clinician after receiving resistance testing results
timeFrame: up to 45 days
measure: Relationship between prior number of PIs utilized and number of available (sensitive) PIs as determined by resistance testing
timeFrame: up to 45 days
measure: The physician's assessment of whether the phenotypic testing (as part of combined testing) provided more information than the genotypic test alone did
timeFrame: up to 45 days
measure: Physician reported limitations that influence access to resistance testing
timeFrame: day 1
measure: Clinician reported reasons why tipranavir was or was not considered as an option for each patient
timeFrame: up to 45 days
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: Boehringer Ingelheim Investigational Site
state: California
city: Beverly Hills
country: United States
facility: Boehringer Ingelheim Investigational Site
state: California
city: Fountain Valley
country: United States
facility: Boehringer Ingelheim Investigational Site
state: California
city: Los Angeles
country: United States
facility: Boehringer Ingelheim Investigational Site
state: California
city: Los Angeles
country: United States
facility: Boehringer Ingelheim Investigational Site
state: California
city: Newport Beach
country: United States
facility: Boehringer Ingelheim Investigational Site
state: California
city: Oakland
country: United States
facility: Boehringer Ingelheim Investigational Site
state: California
city: Stanford
country: United States
facility: Boehringer Ingelheim Investigational Site
state: California
city: Daytona Beach
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Florida
city: Ft. Lauderdale
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Florida
city: Ft. Lauderdale
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Florida
city: Miami
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Florida
city: Miami
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Florida
city: North Palm Beach
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Florida
city: Pensacola
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Florida
city: Chicago
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Illinois
city: New Orleans
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Louisiana
city: Baltimore
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Maryland
city: Springfield
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Massachusetts
city: Berkley
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Michigan
city: St. Louis
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Missouri
city: Camden
country: United States
facility: Boehringer Ingelheim Investigational Site
state: New Jersey
city: Newark
country: United States
facility: Boehringer Ingelheim Investigational Site
state: New Jersey
city: Newark
country: United States
facility: Boehringer Ingelheim Investigational Site
state: New Jersey
city: Voorhees
country: United States
facility: Boehringer Ingelheim Investigational Site
state: New Jersey
city: Rochester
country: United States
facility: Boehringer Ingelheim Investigational Site
state: New York
city: Charlotte
country: United States
facility: Boehringer Ingelheim Investigational Site
state: North Carolina
city: Huntersville
country: United States
facility: Boehringer Ingelheim Investigational Site
state: North Carolina
city: Akron
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Ohio
city: Portland
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Oregon
city: Dallas
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Texas
city: Fort Worth
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Texas
city: Houston
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Texas
city: Hampton
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Virginia
city: Ponce
country: Puerto Rico
facility: Boehringer Ingelheim Investigational Site
city: Ponce
country: Puerto Rico
facility: Boehringer Ingelheim Investigational Site
Study officials:
affiliation: B.I. Pharmaceuticals,Inc./Ridgefield
name: Boehringer Ingelheim Study Coordinator
role: STUDY_CHAIR
References: