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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| genotype test |
| ||
| combined phenotype/genotype test |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NO BI Drug administered | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Level of sensitivity of a patient's HIV-1 isolate to tipranavir | Day 1 | |
| Levels of sensitivity of a patient's HIV-1 isolate to other marketed ARVs (PIs, NRTIs, and NNRTIs). | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 1 | |
| PI that was discontinued or initiated after receiving resistance testing results | up to 45 days |
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Inclusion criteria
Patients that meet the following inclusion criteria will be eligible for participation in this study:
Exclusion criteria
A patient with any of the following criteria will be excluded from participation in the study:
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Primary care clinic
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim Study Coordinator | B.I. Pharmaceuticals,Inc./Ridgefield | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boehringer Ingelheim Investigational Site | Bakersfield | California | 93301 | United States | ||
| Boehringer Ingelheim Investigational Site |
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| Non-PI ARVs that were discontinued or initiated after receiving resistance testing results | up to 45 days |
| Rationale reported for modifying or not modifying baseline ARV regimen after receiving resistance testing results | up to 45 days |
| Utilization (yes/no) of expert interpretation by a clinician after receiving resistance testing results | up to 45 days |
| Relationship between prior number of PIs utilized and number of available (sensitive) PIs as determined by resistance testing | 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 | up to 45 days |
| Physician reported limitations that influence access to resistance testing | day 1 |
| Clinician reported reasons why tipranavir was or was not considered as an option for each patient | up to 45 days |
| Beverly Hills |
| California |
| 90211 |
| United States |
| Boehringer Ingelheim Investigational Site | Fountain Valley | California | 92708 | United States |
| Boehringer Ingelheim Investigational Site | Los Angeles | California | 90028 | United States |
| Boehringer Ingelheim Investigational Site | Los Angeles | California | 90069 | United States |
| Boehringer Ingelheim Investigational Site | Newport Beach | California | 92663 | United States |
| Boehringer Ingelheim Investigational Site | Oakland | California | 94609 | United States |
| Boehringer Ingelheim Investigational Site | Stanford | California | 94305-5107 | United States |
| Boehringer Ingelheim Investigational Site | Daytona Beach | Florida | 32117 | United States |
| Boehringer Ingelheim Investigational Site | Fort Lauderdale | Florida | 33308 | United States |
| Boehringer Ingelheim Investigational Site | Fort Lauderdale | Florida | 33316 | United States |
| Boehringer Ingelheim Investigational Site | Miami | Florida | 33133 | United States |
| Boehringer Ingelheim Investigational Site | Miami | Florida | 33137 | United States |
| Boehringer Ingelheim Investigational Site | North Palm Beach | Florida | 33408 | United States |
| Boehringer Ingelheim Investigational Site | Pensacola | Florida | 32504 | United States |
| Boehringer Ingelheim Investigational Site | Chicago | Illinois | 60613 | United States |
| Boehringer Ingelheim Investigational Site | New Orleans | Louisiana | 70121 | United States |
| Boehringer Ingelheim Investigational Site | Baltimore | Maryland | 21201 | United States |
| Boehringer Ingelheim Investigational Site | Springfield | Massachusetts | 01107 | United States |
| Boehringer Ingelheim Investigational Site | Berkley | Michigan | 48072 | United States |
| Boehringer Ingelheim Investigational Site | St Louis | Missouri | 63139 | United States |
| Boehringer Ingelheim Investigational Site | Camden | New Jersey | 08103 | United States |
| Boehringer Ingelheim Investigational Site | Newark | New Jersey | 07102 | United States |
| Boehringer Ingelheim Investigational Site | Newark | New Jersey | 07103 | United States |
| Boehringer Ingelheim Investigational Site | Voorhees Township | New Jersey | 08043 | United States |
| Boehringer Ingelheim Investigational Site | Rochester | New York | 14604 | United States |
| Boehringer Ingelheim Investigational Site | Charlotte | North Carolina | 28209 | United States |
| Boehringer Ingelheim Investigational Site | Huntersville | North Carolina | 28078 | United States |
| Boehringer Ingelheim Investigational Site | Akron | Ohio | 44304 | United States |
| Boehringer Ingelheim Investigational Site | Portland | Oregon | 97209 | United States |
| Boehringer Ingelheim Investigational Site | Dallas | Texas | 75246 | United States |
| Boehringer Ingelheim Investigational Site | Fort Worth | Texas | 76104 | United States |
| Boehringer Ingelheim Investigational Site | Houston | Texas | 77004 | United States |
| Boehringer Ingelheim Investigational Site | Hampton | Virginia | 23666 | United States |
| Boehringer Ingelheim Investigational Site | Ponce | 00717-1563 | Puerto Rico |
| Boehringer Ingelheim Investigational Site | Ponce | 00731 | Puerto Rico |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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