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

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

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

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Anti-Retroviral Agents; Enfuvirtide

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.