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

This study has been completed.

First Received on October 4, 2005. Last Updated on May 13, 2009 History of Changes

Sponsor:	Hoffmann-La Roche
Collaborator:	Trimeris
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00233883

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 IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: 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

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Enfuvirtide

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Composite endpoint (pain, induration, nodules/cysts). [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Enrollment:	58
Study Completion Date:	July 2006

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

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, 90036

Los Angeles, California, United States, 90210

Los Angeles, California, United States, 90022
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

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Clinical Trials, Study Director, Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00233883 History of Changes
Other Study ID Numbers:	ML18596
Study First Received:	October 4, 2005
Last Updated:	May 13, 2009
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

Slow Virus Diseases
Enfuvirtide
HIV Fusion Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012