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

NCT ID: NCT00615563

Last Updated: 2013-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

246 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-03-31

Study Completion Date

2008-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV Infections

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

genotype test

NO BI Drug administered

Intervention Type BEHAVIORAL

combined phenotype/genotype test

NO BI Drug administered

Intervention Type BEHAVIORAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

NO BI Drug administered

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Boehringer Ingelheim Study Coordinator

Role: STUDY_CHAIR

B.I. Pharmaceuticals,Inc./Ridgefield

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Boehringer Ingelheim Investigational Site

Bakersfield, California, United States

Site Status

Boehringer Ingelheim Investigational Site

Beverly Hills, California, United States

Site Status

Boehringer Ingelheim Investigational Site

Fountain Valley, California, United States

Site Status

Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Site Status

Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Site Status

Boehringer Ingelheim Investigational Site

Newport Beach, California, United States

Site Status

Boehringer Ingelheim Investigational Site

Oakland, California, United States

Site Status

Boehringer Ingelheim Investigational Site

Stanford, California, United States

Site Status

Boehringer Ingelheim Investigational Site

Daytona Beach, Florida, United States

Site Status

Boehringer Ingelheim Investigational Site

Fort Lauderdale, Florida, United States

Site Status

Boehringer Ingelheim Investigational Site

Fort Lauderdale, Florida, United States

Site Status

Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Site Status

Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Site Status

Boehringer Ingelheim Investigational Site

North Palm Beach, Florida, United States

Site Status

Boehringer Ingelheim Investigational Site

Pensacola, Florida, United States

Site Status

Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Site Status

Boehringer Ingelheim Investigational Site

New Orleans, Louisiana, United States

Site Status

Boehringer Ingelheim Investigational Site

Baltimore, Maryland, United States

Site Status

Boehringer Ingelheim Investigational Site

Springfield, Massachusetts, United States

Site Status

Boehringer Ingelheim Investigational Site

Berkley, Michigan, United States

Site Status

Boehringer Ingelheim Investigational Site

St Louis, Missouri, United States

Site Status

Boehringer Ingelheim Investigational Site

Camden, New Jersey, United States

Site Status

Boehringer Ingelheim Investigational Site

Newark, New Jersey, United States

Site Status

Boehringer Ingelheim Investigational Site

Newark, New Jersey, United States

Site Status

Boehringer Ingelheim Investigational Site

Voorhees Township, New Jersey, United States

Site Status

Boehringer Ingelheim Investigational Site

Rochester, New York, United States

Site Status

Boehringer Ingelheim Investigational Site

Charlotte, North Carolina, United States

Site Status

Boehringer Ingelheim Investigational Site

Huntersville, North Carolina, United States

Site Status

Boehringer Ingelheim Investigational Site

Akron, Ohio, United States

Site Status

Boehringer Ingelheim Investigational Site

Portland, Oregon, United States

Site Status

Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

Site Status

Boehringer Ingelheim Investigational Site

Fort Worth, Texas, United States

Site Status

Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Site Status

Boehringer Ingelheim Investigational Site

Hampton, Virginia, United States

Site Status

Boehringer Ingelheim Investigational Site

Ponce, , Puerto Rico

Site Status

Boehringer Ingelheim Investigational Site

Ponce, , Puerto Rico

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Puerto Rico

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1182.116

Identifier Type: -

Identifier Source: org_study_id