Trial Information

Summary: A Study Comparing the Efficacy and Safety of Once-Daily Fuzeon (Enfuvirtide) Dosing Versus the Currently Recommended Twice-Daily Dosing in Human Immunodeficiency Virus-Type 1 (HIV-1) Infected Patients

Status: Completed

Protocol Number: NV17658

Sponsor: Hoffmann-La Roche; Trimeris Inc.

Company Division: Pharmaceutical

Official Scientific Title: A Phase II open-label, randomized, active-controlled study comparing the efficacy and safety of once daily enfuvirtide dosing versus the currently recommended twice daily dosing in HIV-1 infected treatment-experienced patients.

Brief Summary: This study will assess the safety and efficacy of once-daily administration of Fuzeon compared with twice-daily administration in HIV-1 infected patients who have received prior treatment. Patients will also receive an optimized treatment consisting of antiretroviral (ARV) therapy as determined by the treating physician. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals. Target sample size is 60.

Study Phase: II

Study Design / Study Details:

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

Study Type:

Interventional

Condition: HIV Infections

Intervention Type: Drug

Intervention Name: enfuvirtide [Fuzeon]

Primary Outcome: 1. Viral load. Time frame: Week 48

Key Secondary Outcomes: 1. CD4 lymphocyte count. Time frame: Week 48 2. AEs, laboratory abnormalities, local injection site reactions, AIDS-defining events. Time frame: Throughout study

Inclusion Criteria:

  • HIV-1 infected adults or adolescents >=16 years of age;
  • HIV-1 RNA >=5000 copies/mL;
  • prior experience or documented resistance to each of the 3 currently available classes of ARV drugs (nucleoside reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors, and protease inhibitors).

Exclusion Criteria:

  • history of prior use of Fuzeon or T-1249;
  • female patients who are pregnant or breastfeeding, or who plan to become pregnant during the study;
  • current severe illness;
  • currently taking drugs affecting the immune system, HIV vaccine, or investigational agents for any conditions other than HIV/AIDS.

Gender: Males or Females

Age Limits: Min: 16 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 04/05/2005

Date Last Updated: 09/19/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Hobson City , AL 36201
Telephone: 973-235-5000 or 800-526-6367

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Trial listings updated: October 6, 2008 at 2:35:48 PM


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