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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00089492
Recruitment Status : Completed
First Posted : August 6, 2004
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Optimized Background ARVs Drug: enfuvirtide [Fuzeon] Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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.
Study Start Date : July 2004
Actual Primary Completion Date : June 2006
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Enfuvirtide

Arm Intervention/treatment
Experimental: 1 Drug: Optimized Background ARVs
As prescribed

Drug: enfuvirtide [Fuzeon]
180mg sc once daily for 48 weeks

Active Comparator: 2 Drug: Optimized Background ARVs
As prescribed

Drug: enfuvirtide [Fuzeon]
90mg sc bid for 48 weeks

Primary Outcome Measures :
  1. Viral load.\n\n [ Time Frame: Week 48 ]

Secondary Outcome Measures :
  1. CD4 lymphocyte count. [ Time Frame: Week 48 ]
  2. AEs, laboratory abnormalities, local injection site reactions, AIDS-defining events.\n [ Time Frame: Throughout study ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00089492

  Hide Study Locations
United States, Alabama
Hobson City, Alabama, United States, 36201
United States, California
Fountain Valley, California, United States, 92708
Los Angeles, California, United States, 90022
Los Angeles, California, United States, 90048
United States, Colorado
Denver, Colorado, United States, 80262
United States, 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
United States, Georgia
Atlanta, Georgia, United States, 30308
United States, Louisiana
New Orleans, Louisiana, United States, 70112
United States, Massachusetts
Boston, Massachusetts, United States, 02118
United States, Michigan
Detroit, Michigan, United States, 48202-2689
United States, New Jersey
Union, New Jersey, United States, 07083
United States, New York
Albany, New York, United States, 12208
United States, Pennsylvania
Allentown, Pennsylvania, United States, 18102-7017
Philadelphia, Pennsylvania, United States, 19102
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Austin, Texas, United States, 78705
Houston, Texas, United States, 77030
Canada, Ontario
Toronto, Ontario, Canada, M5G 2C4
Canada, 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
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche Identifier: NCT00089492     History of Changes
Other Study ID Numbers: NV17658
First Posted: August 6, 2004    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
HIV Fusion Inhibitors
Viral Fusion Protein Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents