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

This study has been completed.
Sponsor:
Collaborator:
Trimeris
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00089492
First received: August 5, 2004
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

This study will assess the safety and efficacy of once-daily administration of F uzeon compared with twice-daily administration in HIV-1 infected patients who ha ve received prior treatment. Patients will also receive an optimized treatment c onsisting of antiretroviral (ARV) therapy as determined by the treating physicia n. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Condition Intervention Phase
HIV Infections
Drug: enfuvirtide [Fuzeon]
Drug: Optimized Background ARVs
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Viral load.\n\n [ Time Frame: Week 48 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CD4 lymphocyte count. [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  • AEs, laboratory abnormalities, local injection site reactions, AIDS-defining events.\n [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 64
Study Start Date: July 2004
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: enfuvirtide [Fuzeon]
180mg sc once daily for 48 weeks
Drug: Optimized Background ARVs
As prescribed
Active Comparator: 2 Drug: enfuvirtide [Fuzeon]
90mg sc bid for 48 weeks
Drug: Optimized Background ARVs
As prescribed

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00089492

  Hide Study Locations
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, 19107
Philadelphia, Pennsylvania, United States, 19102
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, 00935
San Juan, Puerto Rico, 00921-3201
Sponsors and Collaborators
Hoffmann-La Roche
Trimeris
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00089492     History of Changes
Other Study ID Numbers: NV17658
Study First Received: August 5, 2004
Last Updated: July 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Enfuvirtide
HIV Fusion Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 01, 2014