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

Boehringer Ingelheim246 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

246

Conditions

HIV Infections

Interventions

NO BI Drug administeredBEHAVIORAL

Eligibility

Sex: ALLMin age: 18 YearsMax age: 18 Years

Medical Language ↔ Plain English

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.

Locations (36)

Outcomes

Primary Outcomes

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

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

Data from ClinicalTrials.gov

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