Clinical Trials

MainTitle

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
Hoffmann-La Roche

Collaborator
Trimeris

Information provided by (Responsible Party)
Hoffmann-La Roche
ClinicalTrials.gov Identifier
NCT00233883

First received: October 4, 2005
Last updated: November 2, 2015
Last Verified: November 2015
History of Changes
Purpose

Purpose

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 Intervention Phase
HIV Infections

Drug : enfuvirtide [Fuzeon]
Phase 4

Study Type: Interventional
Study Design: 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

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures

  • Composite endpoint (pain, induration, nodules/cysts). [ Time Frame: Throughout study ]
Secondary Outcome Measures:
  • Steady state C trough [ Time Frame: Weekly ]
  • Signs and symptoms associated with Fuzeon injections [ Time Frame: Throughout study ]

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

Eligibility

Ages Eligible for Study: 18 Years and older  
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

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, 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

More Information


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 2, 2015  

Additional relevant MeSH terms:
HIV Infections
Enfuvirtide

ClinicalTrials.gov processed this data on December 18, 2017
This information is provided by ClinicalTrials.gov.