Back to resultsWAND Study - A Study to Evaluate Fuzeon (Enfuvirtide) Administered by a Needle-Free Injection Device in Patients With HIV.
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
enfuvirtide [Fuzeon]
enfuvirtide [Fuzeon]
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Composite endpoint (pain, induration, nodules/cysts).
Secondary Outcome Measures
Steady state C trough
Signs and symptoms associated with Fuzeon injections
Full Information
NCT ID
NCT00233883
First Posted
October 4, 2005
Last Updated
November 2, 2015
Sponsor
Hoffmann-La Roche
Collaborators
Trimeris
1. Study Identification
Unique Protocol Identification Number
NCT00233883
Brief Title
WAND Study - A Study to Evaluate Fuzeon (Enfuvirtide) Administered by a Needle-Free Injection Device in Patients With HIV.
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 Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
July 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
Collaborators
Trimeris
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
enfuvirtide [Fuzeon]
Intervention Description
90mg sc bid by Biojector 2000 NFID for 4 weeks
Intervention Type
Drug
Intervention Name(s)
enfuvirtide [Fuzeon]
Intervention Description
90mg sc bid by 27G1/2" needle/syringe for 4 weeks
Primary Outcome Measure Information:
Title
Composite endpoint (pain, induration, nodules/cysts).
Time Frame
Throughout study
Secondary Outcome Measure Information:
Title
Steady state C trough
Time Frame
Weekly
Title
Signs and symptoms associated with Fuzeon injections
Time Frame
Throughout study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90022
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90210
Country
United States
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20009
Country
United States
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33334
Country
United States
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215-3318
Country
United States
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63139
Country
United States
City
Winston-salem
State/Province
North Carolina
ZIP/Postal Code
27157-1082
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
City
Annandale
State/Province
Virginia
ZIP/Postal Code
22003
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
18771056
Citation
Gottlieb M, Thommes JA; WAND Study Team. Short communication safety, tolerability and pharmacokinetics of enfuvirtide administered by a needle-free injection system compared with subcutaneous injection. Antivir Ther. 2008;13(5):723-7.
Results Reference
derived
Learn more about this trial
WAND Study - A Study to Evaluate Fuzeon (Enfuvirtide) Administered by a Needle-Free Injection Device in Patients With HIV.
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