Utilization of HIV Drug Resistance Testing in Treatment Experienced Patients (UTILIZE Study)
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ClinicalTrials.gov Identifier: NCT00615563 |
Recruitment Status
:
Completed
First Posted
: February 14, 2008
Last Update Posted
: November 21, 2013
|
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Condition or disease | Intervention/treatment |
---|---|
HIV Infections | Behavioral: NO BI Drug administered |
Study Type : | Observational |
Actual Enrollment : | 246 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Utilization of HIV Drug Resistance Testing in Treatment Experienced Patients (UTILIZE Study) |
Study Start Date : | March 2007 |
Actual Primary Completion Date : | January 2008 |
Study Completion Date : | January 2008 |

Group/Cohort | Intervention/treatment |
---|---|
genotype test | Behavioral: NO BI Drug administered |
combined phenotype/genotype test | Behavioral: NO BI Drug administered |
- 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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 18 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00615563

Study Chair: | Boehringer Ingelheim Study Coordinator | B.I. Pharmaceuticals,Inc./Ridgefield |
ClinicalTrials.gov Identifier: | NCT00615563 History of Changes |
Other Study ID Numbers: |
1182.116 |
First Posted: | February 14, 2008 Key Record Dates |
Last Update Posted: | November 21, 2013 |
Last Verified: | November 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 |