HIV Infections
Conditions
Brief 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 HAART regimen.
Interventions
BEHAVIORALNO BI Drug administered
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
Patients that meet the following inclusion criteria will be eligible for participation in this study: 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.
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| 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 |
| Relationship between prior number of PIs utilized and number of available (sensitive) PIs as determined by resistance testing | up to 45 days |
| PI that was discontinued or initiated after receiving resistance testing results | up to 45 days |
Countries
Puerto Rico, United States
Outcome results
None listed