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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00233883

Enrollment

Registered

2005-10-06

Start date

2005-08-31

Completion date

2006-07-31

Last updated

2015-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

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.

Interventions

DRUGenfuvirtide [Fuzeon]

90mg sc bid by Biojector 2000 NFID for 4 weeks

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Composite endpoint (pain, induration, nodules/cysts).	Throughout study

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026