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

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ClinicalTrials.gov Identifier: NCT00233883
Recruitment Status : Completed
First Posted : October 6, 2005
Last Update Posted : November 3, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to evaluate the tolerability of a subcutaneous needle-free injection device used to administer Fuzeon, compared with the standard needle/syringe supplied with commercial Fuzeon. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: enfuvirtide [Fuzeon] Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : August 2005
Primary Completion Date : July 2006
Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Enfuvirtide
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Composite endpoint (pain, induration, nodules/cysts). [ Time Frame: Throughout study ]

Secondary Outcome Measures :
  1. Steady state C trough [ Time Frame: Weekly ]
  2. Signs and symptoms associated with Fuzeon injections [ Time Frame: Throughout study ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): NCT00233883


Locations
United States, California
Long Beach, California, United States, 90813
Los Angeles, California, United States, 90022
Los Angeles, California, United States, 90036
Los Angeles, California, United States, 90210
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

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
First Posted: October 6, 2005    Key Record Dates
Last Update Posted: November 3, 2015
Last Verified: November 2015

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
Enfuvirtide
HIV Fusion Inhibitors
Viral Fusion Protein Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents