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Utilization of HIV Drug Resistance Testing in Treatment Experienced Patients (UTILIZE Study)
This study has been completed.
Sponsor:
Boehringer Ingelheim
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00615563
First received: January 31, 2008
Last updated: November 20, 2013
Last verified: November 2013
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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:
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 ]
- Levels of sensitivity of a patient's HIV-1 isolate to other marketed ARVs (PIs, NRTIs, and NNRTIs). [ Time Frame: Day 1 ]
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 ]
- PI that was discontinued or initiated after receiving resistance testing results [ Time Frame: up to 45 days ]
- Non-PI ARVs that were discontinued or initiated after receiving resistance testing results [ Time Frame: up to 45 days ]
- Rationale reported for modifying or not modifying baseline ARV regimen after receiving resistance testing results [ Time Frame: up to 45 days ]
- Utilization (yes/no) of expert interpretation by a clinician after receiving resistance testing results [ Time Frame: up to 45 days ]
- Relationship between prior number of PIs utilized and number of available (sensitive) PIs as determined by resistance testing [ Time Frame: up to 45 days ]
- 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 ]
- Physician reported limitations that influence access to resistance testing [ Time Frame: day 1 ]
- Clinician reported reasons why tipranavir was or was not considered as an option for each patient [ Time Frame: up to 45 days ]
| 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) |
| Sexes Eligible for Study: | All |
| 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
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 |
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 July 24, 2017