BLQ Study: A Study of a Protease Inhibitor With Fuzeon (Enfuvirtide) in Treatment-Experienced Patients With HIV-1.

• Status: Completed
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

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, triple-class treatment-experienced, Fuzeon-naive adults. The new investigational PI will be administered according to the procedures of the early access program in which the patient is enrolled. The anticipated time on study treatment is 3-12 months, and the target sample size is approximately 120 individuals.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Collaborator: Trimeris
• Treatments: Darunavir; Enfuvirtide; HIV Protease Inhibitors; Protease Inhibitors

Criteria

Inclusion Criteria:

• 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 Criteria:

• females who are pregnant or breast-feeding;

• evidence of active, untreated opportunistic infection;

• malignancy requiring chemotherapy or radiotherapy.