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

November 2, 2015 updated by: Hoffmann-La Roche

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Long Beach, California, United States, 90813
      • Los Angeles, California, United States, 90036
      • Los Angeles, California, United States, 90022
      • Los Angeles, California, United States, 90210
    • District of Columbia
      • Washington, District of Columbia, United States, 20009
    • Florida
      • Fort Lauderdale, Florida, United States, 33334
      • South Miami, Florida, United States, 33143
    • Georgia
      • Atlanta, Georgia, United States, 30309
    • Illinois
      • Chicago, Illinois, United States, 60612
      • Chicago, Illinois, United States, 60657
    • Massachusetts
      • Boston, Massachusetts, United States, 02215-3318
    • Michigan
      • Detroit, Michigan, United States, 48201
    • Missouri
      • St Louis, Missouri, United States, 63139
    • North Carolina
      • Winston-salem, North Carolina, United States, 27157-1082
    • Texas
      • Dallas, Texas, United States, 75246
      • Houston, Texas, United States, 77004
    • Virginia
      • Annandale, Virginia, United States, 22003

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
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
Active Comparator: 2
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Composite endpoint (pain, induration, nodules/cysts).
Time Frame: Throughout study
Throughout study

Secondary Outcome Measures

Outcome Measure
Time Frame
Steady state C trough
Time Frame: Weekly
Weekly
Signs and symptoms associated with Fuzeon injections
Time Frame: Throughout study
Throughout study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Collaborators

Trimeris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (Actual)

July 1, 2006

Study Completion (Actual)

July 1, 2006

Study Registration Dates

First Submitted

October 4, 2005

First Submitted That Met QC Criteria

October 4, 2005

First Posted (Estimate)

October 6, 2005

Study Record Updates

Last Update Posted (Estimate)

November 3, 2015

Last Update Submitted That Met QC Criteria

November 2, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML18596

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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