HIV InfectionsNCT00615563
Utilization of HIV Drug Resistance Testing in Treatment Experienced Patients (UTILIZE Study)
An observational study of HIV Infections, run by Boehringer Ingelheim at 36 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 18 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- NO BI Drug administered
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 246 participants
- Where
- 36 sitesin 2 countries
- Study dates
- Mar 2007to Jan 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 18 years
- All sexes
- No healthy volunteers
- Adult
Study population: Primary care clinic
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
36 sites in 2 countries.
36 sites in 2 countries
United States34 sites
Boehringer Ingelheim Investigational Site
Akron, Ohio, 44304
Boehringer Ingelheim Investigational Site
Bakersfield, California, 93301
Boehringer Ingelheim Investigational Site
Baltimore, Maryland, 21201
Boehringer Ingelheim Investigational Site
Berkley, Michigan, 48072
Boehringer Ingelheim Investigational Site
Beverly Hills, California, 90211
Boehringer Ingelheim Investigational Site
Camden, New Jersey, 08103
Boehringer Ingelheim Investigational Site
Charlotte, North Carolina, 28209
Boehringer Ingelheim Investigational Site
Chicago, Illinois, 60613
Boehringer Ingelheim Investigational Site
Dallas, Texas, 75246
Boehringer Ingelheim Investigational Site
Daytona Beach, Florida, 32117
Boehringer Ingelheim Investigational Site
Fort Lauderdale, Florida, 33308
Boehringer Ingelheim Investigational Site
Fort Lauderdale, Florida, 33316
Boehringer Ingelheim Investigational Site
Fort Worth, Texas, 76104
Boehringer Ingelheim Investigational Site
Fountain Valley, California, 92708
Boehringer Ingelheim Investigational Site
Hampton, Virginia, 23666
Boehringer Ingelheim Investigational Site
Houston, Texas, 77004
Boehringer Ingelheim Investigational Site
Huntersville, North Carolina, 28078
Boehringer Ingelheim Investigational Site
Los Angeles, California, 90028
Boehringer Ingelheim Investigational Site
Los Angeles, California, 90069
Boehringer Ingelheim Investigational Site
Miami, Florida, 33133
Boehringer Ingelheim Investigational Site
Miami, Florida, 33137
Boehringer Ingelheim Investigational Site
New Orleans, Louisiana, 70121
Boehringer Ingelheim Investigational Site
Newark, New Jersey, 07102
Boehringer Ingelheim Investigational Site
Newark, New Jersey, 07103
Boehringer Ingelheim Investigational Site
Newport Beach, California, 92663
Boehringer Ingelheim Investigational Site
North Palm Beach, Florida, 33408
Boehringer Ingelheim Investigational Site
Oakland, California, 94609
Boehringer Ingelheim Investigational Site
Pensacola, Florida, 32504
Boehringer Ingelheim Investigational Site
Portland, Oregon, 97209
Boehringer Ingelheim Investigational Site
Rochester, New York, 14604
Boehringer Ingelheim Investigational Site
Springfield, Massachusetts, 01107
Boehringer Ingelheim Investigational Site
St Louis, Missouri, 63139
Boehringer Ingelheim Investigational Site
Stanford, California, 94305-5107
Boehringer Ingelheim Investigational Site
Voorhees Township, New Jersey, 08043
Puerto Rico2 sites
Boehringer Ingelheim Investigational Site
Ponce, 00717-1563
Boehringer Ingelheim Investigational Site
Ponce, 00731
About this study
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.
- Conditions
- HIV Infections
- Being tested
- NO BI Drug administered
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NO BI Drug administeredBehavioural
| Study group | Role | What they receive |
|---|---|---|
| genotype test | Not described Receives: Behavioral: NO BI Drug administered | |
| combined phenotype/genotype test | Not described Receives: Behavioral: NO BI Drug administered |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of sensitivity of a patient's HIV-1 isolate to tipranavir
Measured: Day 1
Levels of sensitivity of a patient's HIV-1 isolate to other marketed ARVs (PIs, NRTIs, and NNRTIs).
Measured: Day 1
Secondary outcomes (9)
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
Measured: Day 1
PI that was discontinued or initiated after receiving resistance testing results
Measured: up to 45 days
Non-PI ARVs that were discontinued or initiated after receiving resistance testing results
Measured: up to 45 days
Rationale reported for modifying or not modifying baseline ARV regimen after receiving resistance testing results
Measured: up to 45 days
Utilization (yes/no) of expert interpretation by a clinician after receiving resistance testing results
Measured: up to 45 days
Relationship between prior number of PIs utilized and number of available (sensitive) PIs as determined by resistance testing
Measured: 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
Measured: up to 45 days
Physician reported limitations that influence access to resistance testing
Measured: day 1
Clinician reported reasons why tipranavir was or was not considered as an option for each patient
Measured: up to 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2008 (estimated)
- Study startMar 2007
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim Study Coordinator, Study chair, B.I. Pharmaceuticals,Inc./Ridgefield
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00615563
- Sponsor's protocol ID
- 1182.116
- Status last verified
- Nov 2013
- First submitted
- 31 Jan 2008
- Last updated
- 21 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilization of HIV Drug Resistance Testing in Treatment Experienced Patients (UTILIZE Study)
- ClinicalTrials.gov ID
- NCT00615563
- Acronym / sponsor ID
- 1182.116
- Conditions
- HIV Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008
- First posted
- 14 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| genotype test | – | Behavioral: NO BI Drug administered |
| combined phenotype/genotype test | – | Behavioral: NO BI Drug administered |
Who may qualify
- Ages
- 18 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Primary care clinic
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NO BI Drug administered | Behavioural | combined phenotype/genotype test, genotype test |
Primary outcome
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
9 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim Study Coordinator study chair
B.I. Pharmaceuticals,Inc./Ridgefield
36 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by Boehringer Ingelheim at 36 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of sensitivity of a patient's HIV-1 isolate to tipranavir (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2013.