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

Hoffmann-La Roche58 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

HIV Infections

Interventions

enfuvirtide [Fuzeon]DRUG

90mg sc bid by Biojector 2000 NFID for 4 weeks

enfuvirtide [Fuzeon]DRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (17)

Unnamed facility

Long Beach, California, United States

Unnamed facility

Los Angeles, California, United States

Unnamed facility

Los Angeles, California, United States

Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.