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

Phase 4

Completed

• Conditions: HIV Infections
• Interventions: Drug: enfuvirtide [Fuzeon]

• Registration Number: NCT00233883
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2005-10-04
• Study First Submitted QC: 2005-10-04
• Study First Posted: 2005-10-06
• Primary Completion: 2006-07
• Study Completion: 2006-07
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-02
• Last Update Posted: 2015-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	enfuvirtide [Fuzeon]	-
1	enfuvirtide [Fuzeon]	-

Primary Outcome Measures

Name	Time	Method
Composite endpoint (pain, induration, nodules/cysts).	Throughout study

Secondary Outcome Measures

Name	Time	Method
Signs and symptoms associated with Fuzeon injections	Throughout study
Steady state C trough	Weekly