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

Plain-language summary

This study looks at the safety of using a protease inhibitor together with enfuvirtide (Fuzeon) in treatment-experienced patients with HIV-1 (human immunodeficiency virus type 1) infection. Adults aged 18 and older who were HIV-1 positive and had already been treated with three classes of antiretroviral drugs were able to take part. Sponsored by Hoffmann-La Roche, the study was conducted in Phase 4 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 4

Status

Completed

Sponsor

Hoffmann-La Roche

Intervention

Background ARVs, PI, enfuvirtide [Fuzeon]

Start date

3/1/2006

Estimated completion

5/1/2007

Countries

United States, Australia

Related genes

Locations

• Phoenix, United States
• Bakersfield, United States
• Beverly Hills, United States
• Los Angeles, United States
• Los Angeles, United States
• Los Angeles, United States
• San Francisco, United States
• Stanford, United States
• Tarzana, United States
• Norwalk, United States
• Washington D.C., United States
• Fort Lauderdale, United States
• Orlando, United States
• Port Saint Lucie, United States
• Decatur, United States
• Macon, United States
• Baltimore, United States
• St Louis, United States
• Newark, United States
• Somers Point, United States
• Albany, United States
• New York, United States
• New York, United States
• Huntersville, United States
• Portland, United States
• Philadelphia, United States
• Dallas, United States
• Fort Worth, United States
• Houston, United States
• Houston, United States
• Annandale, United States
• Hampton, United States
• Brisbane, Australia
• Carlton, Australia
• Liverpool, Australia
• Melbourne, Australia
• South Yarra, Australia
• Sydney, Australia

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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.