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

Completed · Phase 4

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00326963

Run by

Hoffmann-La Roche

People needed

142

Starts

2006-03-01

Expected to finish

2007-05-01

Last updated by the study team

2016-08-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• females who are pregnant or breast-feeding;
• evidence of active, untreated opportunistic infection;
• malignancy requiring chemotherapy or radiotherapy.

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — Bakersfield, California, United States
• Study site — Beverly Hills, California, United States
• Study site — Los Angeles, California, United States
• Study site — Los Angeles, California, United States
• Study site — Los Angeles, California, United States
• Study site — San Francisco, California, United States
• Study site — Stanford, California, United States
• Study site — Tarzana, California, United States
• Study site — Norwalk, Connecticut, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Port Saint Lucie, Florida, United States
• Study site — Decatur, Georgia, United States
• Study site — Macon, Georgia, United States
• Study site — Baltimore, Maryland, United States
• Study site — St Louis, Missouri, United States
• Study site — Newark, New Jersey, United States
• Study site — Somers Point, New Jersey, United States
• Study site — Albany, New York, United States
• Study site — New York, New York, United States
• Study site — New York, New York, United States
• Study site — Huntersville, North Carolina, United States
• Study site — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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