Trial Information

Summary: AMICI Study: A Study of Fuzeon (Enfuvirtide) With an Integrase Inhibitor Plus Optimized Background in Treatment-Experienced HIV-1 Infected Patients.

Status: No longer recruiting

Protocol Number: ML20837

Sponsor: Hoffmann-La Roche; Trimeris Inc.

Company Division: Pharmaceutical

Official Scientific Title: An open label study evaluating the antiviral activity and safety of Fuzeon in triple-class experienced HIV-1 infected patients changing their therapy to a standard of care regimen which includes initiating an integrase inhibitor in an expanded access program plus optimized background

Brief Summary: This 2 arm study will evaluate the efficacy and safety of Fuzeon with an integrase inhibitor in an expanded access program plus optimized background in HIV-1 infected patients naive to Fuzeon and an integrase inhibitor. In the first cohort phase of the study, eligible patients will receive Fuzeon 90mg sc b.i.d. until confirmation of response (min/max = 8/16 weeks). In the second, randomised comparator phase of the study, responders will be randomized to receive Fuzeon either 90mg sc b.i.d. or 180mg qd for a further 24 weeks. Non-responders and virological failures will be terminated from the study. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals. Target sample size is 238.

Study Phase: IV

Study Design / Study Details:

• Purpose: Treatment
• Allocation: Randomized
• Masking: Open Label
• Control: Active
• Assignment: Parallel
• Endpoints: Safety/Efficacy

Study Type:

Condition: HIV Infections

Intervention Type: Drug

Intervention Name: enfuvirtide [Fuzeon]

Primary Outcome: 1. Number and percentage of patients with HIV RNA <50 copies/mL Time frame: Week 12 and Week 38

Key Secondary Outcomes: 1. Mean change in HIV RNA and CD4 from baseline; number and percentage of patients with HIV RNA <=50 copies/mL and <400 copies/mL; number and percentage of patients with >=1 log decline in HIV RNA from baseline. SAEs, ISRs, laboratory parameters. Time frame: Throughout study

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: May, 2007

Trial Registration Date: 06/15/2007

Date Last Updated: 08/18/2008

Link To Trial Results

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Trial listings updated: October 6, 2008 at 2:45:47 PM