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

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.

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Drug: Optimized Background ARVs; Drug: enfuvirtide [Fuzeon]; Drug: enfuvirtide [Fuzeon]

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2C4
  • Quebec
    • Montreal, Quebec, Canada, H2X 2P4
    • Montreal, Quebec, Canada, H3G 1A4
• Puerto Rico
  • Ponce, Puerto Rico, 00732
  • San Juan, Puerto Rico, 00921-3201
  • San Juan, Puerto Rico, 00935
• United States
  • Alabama
    • Hobson City, Alabama, United States, 36201
  • California
    • Fountain Valley, California, United States, 92708
    • Los Angeles, California, United States, 90048
    • Los Angeles, California, United States, 90022
  • Colorado
    • Denver, Colorado, United States, 80262
  • Florida
    • Bradenton, Florida, United States, 34209
    • Miami, Florida, United States, 33136
    • North Miami Beach, Florida, United States, 33169
    • Orlando, Florida, United States, 32803
    • Sarasota, Florida, United States, 34239
  • Georgia
    • Atlanta, Georgia, United States, 30308
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
  • Michigan
    • Detroit, Michigan, United States, 48202-2689
  • New Jersey
    • Union, New Jersey, United States, 07083
  • New York
    • Albany, New York, United States, 12208
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18102-7017
    • Philadelphia, Pennsylvania, United States, 19107
    • Philadelphia, Pennsylvania, United States, 19102
  • Texas
    • Austin, Texas, United States, 78705
    • Houston, Texas, United States, 77030

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 2	Drug: Optimized Background ARVs; As prescribed; Drug: enfuvirtide [Fuzeon]; 180mg sc once daily for 48 weeks; Drug: enfuvirtide [Fuzeon]; 90mg sc bid for 48 weeks
EXPERIMENTAL: 1	Drug: Optimized Background ARVs; As prescribed; Drug: enfuvirtide [Fuzeon]; 180mg sc once daily for 48 weeks; Drug: enfuvirtide [Fuzeon]; 90mg sc bid for 48 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Viral load.\n\n	Week 48

Secondary Outcome Measures

Outcome Measure	Time Frame
CD4 lymphocyte count.	Week 48
AEs, laboratory abnormalities, local injection site reactions, AIDS-defining events.\n	Throughout study

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Collaborators: Trimeris

Publications and helpful links

General Publications

• Wright D, Rodriguez A, Godofsky E, Walmsley S, Labriola-Tompkins E, Donatacci L, Shikhman A, Tucker E, Chiu YY, Chung J, Rowell L, Demasi R, Graham N, Salgo M. Efficacy and safety of 48 weeks of enfuvirtide 180 mg once-daily dosing versus 90 mg twice-daily dosing in HIV-infected patients. HIV Clin Trials. 2008 Mar-Apr;9(2):73-82. doi: 10.1310/hct0902-73.

Study record dates

Study Major Dates

• Study Start: July 1, 2004
• Primary Completion (ACTUAL): June 1, 2006
• Study Completion (ACTUAL): June 1, 2006

Study Registration Dates

• First Submitted: August 5, 2004
• First Submitted That Met QC Criteria: August 5, 2004
• First Posted (ESTIMATE): August 6, 2004

Study Record Updates

• Last Update Posted (ESTIMATE): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Anti-HIV Agents; Anti-Retroviral Agents; HIV Fusion Inhibitors; Viral Fusion Protein Inhibitors; Enfuvirtide
• Other Study ID Numbers: NV17658