A Study to Evaluate the Safety and Efficacy of Adding Enfuvirtide to Oral Highly Active Antiretroviral Therapy (HAART) in Human Immunodeficiency Virus (HIV) Patients With Prior Treatment Experience

Completed · Phase 4

Conditions studied: HIV Infections

In brief

To assess the efficacy of enfuvirtide (Fuzeon) added to HAART compared to treatment with HAART alone in achieving and maintaining viral load suppression.

Key facts

Study ID

NCT00487188

Run by

Hoffmann-La Roche

People needed

47

Starts

2005-11-01

Expected to finish

2008-04-01

Last updated by the study team

2015-08-13

Who can join

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

You may qualify if…

• HIV-1 infected adults >=18 years of age;
• currently on antiretroviral (ARV) therapy;
• previously treated with 2 or 3 different antiretroviral classes;
• HIV-1 Ribonucleic acid (RNA) >=1,000 copies/mL;
• Cluster differentiation antigen four (CD4) lymphocyte count >=200 cells/mm\^3;
• females of childbearing potential must be willing to use a reliable form of effective barrier contraception for the duration of the study and for 30 days after the last dose of study drug.

You may not qualify if…

• history of prior use of enfuvirtide or T-1249;
• women who are pregnant, breastfeeding or planning to become pregnant during the study;
• active, untreated opportunistic infection;
• patients on treatment interruption, or patients interrupting ARV therapy within 4 weeks of screening or during the screening period for reasons either than toxicity management.

Where it is running

• Study site — Cleveland, Ohio, United States
• Study site — Austin, Texas, United States
• Study site — Dallas, Texas, United States
• Study site — Vancouver, British Columbia, Canada
• Study site — Le Kremlin-Bicêtre, France
• Study site — Nantes, France
• Study site — Paris, France
• Study site — Poitiers, France
• Study site — Villeneuve-sur-Lot, France
• Study site — Berlin, Germany
• Study site — Bonn, Germany
• Study site — Erlangen, Germany
• Study site — Frankfurt am Main, Germany
• Study site — Ramat Gan, Israel
• Study site — Bagno a Ripoli, Italy
• Study site — Bari, Italy
• Study site — Brescia, Italy
• Study site — Milan, Italy
• Study site — Milan, Italy
• Study site — Roma, Italy
• Study site — Roma, Italy
• Study site — Mexico City, Mexico
• Study site — Amsterdam, Netherlands
• Study site — Tilburg, Netherlands
• Study site — Barcelona, Spain

Full record on ClinicalTrials.gov

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