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: August 4, 2014
Last verified: August 2014

October 4, 2005
August 4, 2014
August 2005
July 2006   (final data collection date for primary outcome measure)
Composite endpoint (pain, induration, nodules/cysts). [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00233883 on ClinicalTrials.gov Archive Site
  • 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 ]
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 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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00233883
ML18596
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Trimeris
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
August 2014

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