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

Roche

Status and phase: Completed; Phase 4

Conditions: HIV Infections

Treatments: Drug: enfuvirtide [Fuzeon]

Study type: Interventional

Funder types: Industry

Identifiers

NCT00233883

ML18596

Details and patient eligibility

About

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.

Enrollment: 58 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

58 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: enfuvirtide [Fuzeon]

Drug: enfuvirtide [Fuzeon]

2

Active Comparator group

Treatment:

Drug: enfuvirtide [Fuzeon]

Drug: enfuvirtide [Fuzeon]