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WAND Study - A Study to Evaluate Fuzeon (Enfuvirtide) Administered by a Needle-Free Injection Device in Patients With HIV.

This study has been completed.
Sponsor:
Collaborator:
Trimeris
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00233883
First received: October 4, 2005
Last updated: November 3, 2014
Last verified: November 2014
  Purpose

The purpose of this study is to evaluate the tolerability of a subcutaneous need le-free injection device used to administer Fuzeon, compared with the standard n eedle/syringe supplied with commercial Fuzeon. The anticipated time on study tre atment is <3 months, and the target sample size is <100 individuals.


Condition Intervention Phase
HIV Infections
Drug: enfuvirtide [Fuzeon]
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label Study of the Tolerability of a Subcutaneous Needle-free Injection Device Used to Administer Fuzeon, Compared With the Standard Needle/Syringe Supplied With Commercial Fuzeon in HIV-1 Infected, ARV Treatment-experienced Adults

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Composite endpoint (pain, induration, nodules/cysts). [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Steady state C trough [ Time Frame: Weekly ] [ Designated as safety issue: No ]
  • Signs and symptoms associated with Fuzeon injections [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 58
Study Start Date: August 2005
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: enfuvirtide [Fuzeon]
90mg sc bid by Biojector 2000 NFID for 4 weeks
Active Comparator: 2 Drug: enfuvirtide [Fuzeon]
90mg sc bid by 27G1/2" needle/syringe for 4 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • male or female patients, >=18 years of age with HIV-1 infection;
  • previously treated with antiretroviral agents.

Exclusion Criteria:

  • prior use of Fuzeon or T-1249;
  • inability to self-inject;
  • active, untreated opportunistic infection.
  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: NCT00233883

Locations
United States, California
Long Beach, California, United States, 90813
Los Angeles, California, United States, 90036
Los Angeles, California, United States, 90210
Los Angeles, California, United States, 90022
United States, District of Columbia
Washington, District of Columbia, United States, 20009
United States, Florida
Fort Lauderdale, Florida, United States, 33334
South Miami, Florida, United States, 33143
United States, Georgia
Atlanta, Georgia, United States, 30309
United States, Illinois
Chicago, Illinois, United States, 60612
Chicago, Illinois, United States, 60657
United States, Massachusetts
Boston, Massachusetts, United States, 02215-3318
United States, Michigan
Detroit, Michigan, United States, 48201
United States, Missouri
St Louis, Missouri, United States, 63139
United States, North Carolina
Winston-salem, North Carolina, United States, 27157-1082
United States, Texas
Dallas, Texas, United States, 75246
Houston, Texas, United States, 77004
United States, Virginia
Annandale, Virginia, United States, 22003
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: NCT00233883     History of Changes
Other Study ID Numbers: ML18596
Study First Received: October 4, 2005
Last Updated: November 3, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 25, 2014