Current partner codePEPTIDESDE
NCT00233883·Phase 4·INTERVENTIONAL

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

Status

Completed

Phase

Phase 4

Enrollment

58

Locations

17

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

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

Timeline

From registration to results.

  1. First posted

    Oct 6, 2005

  2. Study start

    Aug 2005

  3. Primary completion

    Jul 2006

  4. Study completion

    Jul 2006

  5. Results posted

    Not reported

  6. Registry updated

    Nov 3, 2015

Outcomes

What the study measures.

Primary outcomes

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

Time frame · Throughout study

Secondary outcomes

Steady state C trough

Time frame · Weekly

Signs and symptoms associated with Fuzeon injections

Time frame · Throughout study

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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 locations

17 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Facility not named

Long Beach, California, United States

Facility not named

Los Angeles, California, United States

Facility not named

Los Angeles, California, United States

Facility not named

Los Angeles, California, United States

Facility not named

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

Facility not named

Fort Lauderdale, Florida, United States

Facility not named

South Miami, Florida, United States

Facility not named

Atlanta, Georgia, United States

Facility not named

Chicago, Illinois, United States

Facility not named

Chicago, Illinois, United States

Facility not named

Boston, Massachusetts, United States

Facility not named

Detroit, Michigan, United States

Facility not named

St Louis, Missouri, United States

Facility not named

Winston-Salem, North Carolina, United States

Facility not named

Dallas, Texas, United States

Facility not named

Houston, Texas, United States

Facility not named

Annandale, Virginia, United States

Related trials

More studies on Enfuvirtide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.