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

Boehringer Ingelheim

Status: Completed

Conditions: HIV Infections

Treatments: Behavioral: NO BI Drug administered

Study type: Observational

Funder types: Industry

Identifiers

NCT00615563

1182.116

Details and patient eligibility

About

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.

Enrollment: 246 patients

Sex: All

Ages: 18 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

246 participants in 2 patient groups

genotype test

Treatment:

Behavioral: NO BI Drug administered

combined phenotype/genotype test

Treatment:

Behavioral: NO BI Drug administered