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

Completed

• Conditions: HIV Infections
• Interventions: Behavioral: NO BI Drug administered

• Registration Number: NCT00615563
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Study First Submitted: 2008-01-31
• Study First Submitted QC: 2008-02-13
• Study First Posted: 2008-02-14
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-20
• Last Update Posted: 2013-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 246

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
genotype test	NO BI Drug administered	-
combined phenotype/genotype test	NO BI Drug administered	-

Primary Outcome Measures

Name	Time	Method
Levels of sensitivity of a patient's HIV-1 isolate to other marketed ARVs (PIs, NRTIs, and NNRTIs).	Day 1
Level of sensitivity of a patient's HIV-1 isolate to tipranavir	Day 1

Secondary Outcome Measures

Name	Time	Method
Relationship between prior number of PIs utilized and number of available (sensitive) PIs as determined by resistance testing	up to 45 days
Utilization (yes/no) of expert interpretation by a clinician after receiving resistance testing results	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
Rationale reported for modifying or not modifying baseline ARV regimen 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
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
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

Trial Locations

Locations (1)

Boehringer Ingelheim Investigational Site; 🇵🇷 Ponce, Puerto Rico