Utilization of HIV Drug Resistance Testing in Treatment Experienced Patients (UTILIZE Study)

Study Overview
=================
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.

Official Title
-----------------
Utilization of HIV Drug Resistance Testing in Treatment Experienced Patients (UTILIZE Study)

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Behavioral: NO BI Drug administered


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| genotype test<br> | Behavioral: NO BI Drug administered<br> <br> |
| combined phenotype/genotype test<br> | Behavioral: NO BI Drug administered<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |