NCT00233883

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for phase_4 hiv-infections

Timeline
Completed

Started Aug 2005

Shorter than P25 for phase_4 hiv-infections

Geographic Reach
1 country

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 4, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 6, 2005

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

November 3, 2015

Status Verified

November 1, 2015

Enrollment Period

11 months

First QC Date

October 4, 2005

Last Update Submit

November 2, 2015

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

  • Composite endpoint (pain, induration, nodules/cysts).

    Throughout study

Secondary Outcomes (2)

  • Steady state C trough

    Weekly

  • Signs and symptoms associated with Fuzeon injections

    Throughout study

Study Arms (2)

1

EXPERIMENTAL
Drug: enfuvirtide [Fuzeon]

2

ACTIVE COMPARATOR
Drug: enfuvirtide [Fuzeon]

Interventions

enfuvirtide [Fuzeon]DRUG

90mg sc bid by Biojector 2000 NFID for 4 weeks

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • male or female patients, \>=18 years of age with HIV-1 infection;
  • previously treated with antiretroviral agents.

You may not qualify if:

  • prior use of Fuzeon or T-1249;
  • inability to self-inject;
  • active, untreated opportunistic infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Unknown Facility

Long Beach, California, 90813, United States

Location

Unknown Facility

Los Angeles, California, 90022, United States

Location

Unknown Facility

Los Angeles, California, 90036, United States

Location

Unknown Facility

Los Angeles, California, 90210, United States

Location

Unknown Facility

Washington D.C., District of Columbia, 20009, United States

Location

Unknown Facility

Fort Lauderdale, Florida, 33334, United States

Location

Unknown Facility

South Miami, Florida, 33143, United States

Location

Unknown Facility

Atlanta, Georgia, 30309, United States

Location

Unknown Facility

Chicago, Illinois, 60612, United States

Location

Unknown Facility

Chicago, Illinois, 60657, United States

Location

Unknown Facility

Boston, Massachusetts, 02215-3318, United States

Location

Unknown Facility

Detroit, Michigan, 48201, United States

Location

Unknown Facility

St Louis, Missouri, 63139, United States

Location

Unknown Facility

Winston-Salem, North Carolina, 27157-1082, United States

Location

Unknown Facility

Dallas, Texas, 75246, United States

Location

Unknown Facility

Houston, Texas, 77004, United States

Location

Unknown Facility

Annandale, Virginia, 22003, United States

Location

Related Publications (1)

  • 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.

    PMID: 18771056DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

Enfuvirtide

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Peptide FragmentsPeptidesAmino Acids, Peptides, and ProteinsHIV Envelope Protein gp41Viral Fusion ProteinsMembrane Fusion ProteinsMembrane ProteinsProteinsHIV AntigensAntigens, ViralViral Proteinsenv Gene Products, Human Immunodeficiency VirusGene Products, envRetroviridae ProteinsHuman Immunodeficiency Virus ProteinsViral Envelope ProteinsViral Structural ProteinsAntigensBiological Factors

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2005

First Posted

October 6, 2005

Study Start

August 1, 2005

Primary Completion

July 1, 2006

Study Completion

July 1, 2006

Last Updated

November 3, 2015

Record last verified: 2015-11

Locations

US(17)