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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

246

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Mar 2007

Shorter than P25 for all trials

Geographic Reach

2 countries

36 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

10 months study duration

Study Start

First participant enrolled

March 1, 2007

Completed

10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

January 31, 2008

Completed

14 days until next milestone

First Posted

Study publicly available on registry

February 14, 2008

Completed

Last Updated

November 21, 2013

Status Verified

November 1, 2013

Enrollment Period

10 months

First QC Date

January 31, 2008

Last Update Submit

November 20, 2013

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (2)

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 Outcomes (9)

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
+4 more secondary outcomes

Study Arms (2)

genotype test

Behavioral: NO BI Drug administered

combined phenotype/genotype test

Behavioral: NO BI Drug administered

Interventions

NO BI Drug administeredBEHAVIORAL

combined phenotype/genotype testgenotype test

Eligibility Criteria

Age18 Years - 18 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64)

Sampling MethodProbability Sample

Study Population

Primary care clinic

You may qualify if:

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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.