We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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:
ClinicalTrials.gov Identifier:
NCT00233883
First Posted: October 6, 2005
Last Update Posted: November 3, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Trimeris
Information provided by (Responsible Party):
Hoffmann-La Roche
October 4, 2005
October 6, 2005
November 3, 2015
August 2005
July 2006   (Final data collection date for primary outcome measure)
Composite endpoint (pain, induration, nodules/cysts). [ Time Frame: Throughout study ]
Not Provided
Complete list of historical versions of study NCT00233883 on ClinicalTrials.gov Archive Site
  • Steady state C trough [ Time Frame: Weekly ]
  • Signs and symptoms associated with Fuzeon injections [ Time Frame: Throughout study ]
Not Provided
Not Provided
Not Provided
 
WAND Study - A Study to Evaluate Fuzeon (Enfuvirtide) Administered by a Needle-Free Injection Device in Patients With HIV.
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
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
HIV Infections
  • Drug: enfuvirtide [Fuzeon]
    90mg sc bid by Biojector 2000 NFID for 4 weeks
  • Drug: enfuvirtide [Fuzeon]
    90mg sc bid by 27G1/2" needle/syringe for 4 weeks
  • Experimental: 1
    Intervention: Drug: enfuvirtide [Fuzeon]
  • Active Comparator: 2
    Intervention: Drug: enfuvirtide [Fuzeon]
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
58
July 2006
July 2006   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00233883
ML18596
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Trimeris
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP