Status:
COMPLETED
BLQ Study: A Study of a Protease Inhibitor With Fuzeon (Enfuvirtide) in Treatment-Experienced Patients With HIV-1.
Lead Sponsor:
Hoffmann-La Roche
Collaborating Sponsors:
Trimeris
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This single arm study will evaluate the efficacy, safety and tolerability of a new investigational protease inhibitor (PI) plus background antiretrovirals plus Fuzeon (90mg sc bid) in HIV-1 infected, ...
Eligibility Criteria
Inclusion
- adult patients, \>=18 years of age;
- seropositive for HIV-1;
- enrolled in an early access program for a new investigational PI;
- naive to Fuzeon, and the investigational PI;
- treatment-experienced with 3 ARV classes of drug (NRTI, NNRTI and PI).
Exclusion
- females who are pregnant or breast-feeding;
- evidence of active, untreated opportunistic infection;
- malignancy requiring chemotherapy or radiotherapy.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT00326963
Start Date
March 1 2006
End Date
May 1 2007
Last Update
August 16 2016
Active Locations (38)
Enter a location and click search to find clinical trials sorted by distance.
1
Phoenix, Arizona, United States, 85006
2
Bakersfield, California, United States, 93301
3
Beverly Hills, California, United States, 90210
4
Los Angeles, California, United States, 90027