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

Tracking Information

First Received Date ^ICMJE

October 4, 2005

Last Updated Date

May 13, 2009

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

ISR signs and symptoms, including ongoing pain with the B2000 compared to commercial needle and syringe

Change History

Complete list of historical versions of study NCT00233883 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Comparison of weekly steady-state Ctrough between the B2000 NFID and 27G ½” needle for abdominal injections Adverse events and clinical laboratory abnormalities, including those considered related to the injection device

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Crossover Assignment, Safety Study

Condition ^ICMJE

HIV Infections

Intervention ^ICMJE

Drug: enfuvirtide [Fuzeon]

Study Arms / Comparison Groups

Publications *

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 National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00233883

Responsible Party

Clinical Trials, Study Director, Hoffmann-La Roche

Study ID Numbers ^ICMJE

ML18596

Study Sponsor ^ICMJE

Hoffmann-La Roche

Collaborators ^ICMJE

Trimeris

Investigators ^ICMJE

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

Information Provided By

Hoffmann-La Roche

Verification Date

May 2009

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