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

NCT ID: NCT00233883

Last Updated: 2015-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2006-07-31

Brief Summary

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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

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Conditions

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HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

enfuvirtide [Fuzeon]

Intervention Type DRUG

90mg sc bid by Biojector 2000 NFID for 4 weeks

2

Group Type ACTIVE_COMPARATOR

enfuvirtide [Fuzeon]

Intervention Type DRUG

90mg sc bid by 27G1/2" needle/syringe for 4 weeks

Interventions

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enfuvirtide [Fuzeon]

90mg sc bid by Biojector 2000 NFID for 4 weeks

Intervention Type DRUG

enfuvirtide [Fuzeon]

90mg sc bid by 27G1/2" needle/syringe for 4 weeks

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Trimeris

INDUSTRY

Sponsor Role collaborator

Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Long Beach, California, United States

Site Status

Los Angeles, California, United States

Site Status

Los Angeles, California, United States

Site Status

Los Angeles, California, United States

Site Status

Washington D.C., District of Columbia, United States

Site Status

Fort Lauderdale, Florida, United States

Site Status

South Miami, Florida, United States

Site Status

Atlanta, Georgia, United States

Site Status

Chicago, Illinois, United States

Site Status

Chicago, Illinois, United States

Site Status

Boston, Massachusetts, United States

Site Status

Detroit, Michigan, United States

Site Status

St Louis, Missouri, United States

Site Status

Winston-Salem, North Carolina, United States

Site Status

Dallas, Texas, United States

Site Status

Houston, Texas, United States

Site Status

Annandale, Virginia, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 18771056 (View on PubMed)

Other Identifiers

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ML18596

Identifier Type: -

Identifier Source: org_study_id

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