Trial Information

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

Status: Completed

Protocol Number: ML19712

Sponsor: Hoffmann-La Roche; Trimeris Inc.

Company Division: Pharmaceutical

Official Scientific Title: An open-label study to evaluate the effect on viral load of a new investigational protease inhibitor with Fuzeon plus a background antiretroviral regimen in triple-class treatment-experienced patients with HIV-1 infection

Brief Summary: This single arm study will evaluate the efficacy, safety and tolerability of a new investigational protease inhibitor (PI) plus background antiretrovirals plus Fuzeon (90mg sc bid) in HIV-1 infected, triple-class treatment-experienced, Fuzeon-naive adults. The new investigational PI will be administered according to the procedures of the early access program in which the patient is enrolled. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals. Target sample size is 120.

Study Phase: IV

Study Design / Study Details:

• Purpose: Treatment
• Allocation: Non-Randomized
• Masking: Open Label
• Control: Uncontrolled
• Assignment: Single Group
• Endpoints: Safety/Efficacy

Study Type:

Condition: HIV Infections

Intervention Type: Drug

Intervention Name: enfuvirtide [Fuzeon]

Primary Outcome: 1. Number and percentage of patients with plasma HIV-1 RNA <50 copies/mL Time frame: Week 24

Key Secondary Outcomes: 1. Plasma HIV-1 RNA <50 copies/mL Time frame: Weeks 4 and 12 2. Plasma HIV-1 RNA <400 copies/mL Time frame: Weeks 4, 12 and 24 3. Change from baseline in plasma RNA and CD4 Time frame: Weeks 4, 12 and 24 4. Adherence, ISRs, premature discontinuations, SAEs Time frame: Throughout study

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 05/04/2006

Date Last Updated: 10/17/2008

Link To Trial Results

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Trial listings updated: November 17, 2008 at 2:33:13 PM