Trial Information

Summary: A Study to Assess Fuzeon (Enfuvirtide) in Human Immunodeficiency Virus (HIV)-infected Subjects With Renal Impairment

Status: Completed

Protocol Number: NP17586

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: An open-label study of the pharmacokinetics of Fuzeon in patients with HIV-1 infection and renal impairment

Brief Summary: This study will evaluate if renal impairment and hemodialysis alter the pharmacokinetic effects of Fuzeon in subjects with HIV. The anticipated time on study treatment is <3 months and the target sample size is <100 individuals. Target sample size is 24.

Study Phase: IV

Study Design / Study Details:

• Purpose: Treatment
• Allocation: Non-Randomized
• Masking: Open Label
• Control: Uncontrolled
• Assignment: Parallel
• Endpoints: Pharmacokinetics

Study Type:

Condition: HIV Infections

Intervention Type: Drug

Intervention Name: enfuvirtide[Fuzeon]

Primary Outcome: 1. PK parameters; analysis of dialysate

Key Secondary Outcomes: 1. Vital signs, clinical laboratory tests, adverse events, injection site reactions

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years Max: 64 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 04/05/2005

Date Last Updated: 09/19/2008

Link To Trial Results

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Trial listings updated: October 6, 2008 at 2:35:49 PM