Roche trials database

Trial information

OPTIONS Study: A Study of Three Delivery Mechanisms for Fuzeon.

Status:

Completed

Protocol number:

ML19233

Sponsor:

Hoffmann-La Roche

Company division:

Pharmaceutical

Official Scientific Title:

A study to evaluate the effect of three different delivery mechanisms for Fuzeon on injection site reactions.

Brief summary:

This study will determine whether different mechanisms of delivering Fuzeon have an impact on injection site reactions. HIV-infected adults currently receiving Fuzeon will be randomized to receive Fuzeon 90mg bid sc by a)27 gauge needle b)31 gauge needle or c)Bioject 2000 needle-free device for the first 12 weeks of the study. For weeks 12-24, patients may choose to remain on the randomized arm or may elect to receive one of the other delivery methods. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals. Target sample size is 61.

Study phase:

IV

Study type:

Interventional; Treatment; Randomized; Open Label; Active; Crossover; Safety/efficacy study

Conditions:

• HIV Infections

Intervention type:

Drug

Intervention name:

enfuvirtide [Fuzeon]

Primary outcome:

1. Injection site reactions (diameter, induration, erythema, swelling, pain, interference with normal activities, infection).

Key secondary outcomes:

1. Efficacy: CD4 cell count and HIV RNA viral load at weeks 0,12 and 24. Safety: SAEs. Quality of life: MOS-HIV 30.

Inclusion criteria:

• adult patients >=18 years of age;
• documented chronic HIV infection;
• receiving stable, optimised background antiretroviral regimen including Fuzeon.

Exclusion criteria:

• current use of systemic corticosteroid therapy, or topical or systemic immunomodulators;
• widespread inflammatory skin disease, or other skin disease at potential Fuzeon injection sites;
• widespread topical corticosteroid therapy at potential Fuzeon injection sites.

Gender:

Males or Females

Age limits:

Min: 18 years Max: N/A (No limit)

Accepts healthy volunteers:

No

Anticipated start date:

March, 2006

Trial registration date:

04.04.2006

Date last updated:

22.01.2010

This trial was conducted at the following locations:

Australia

• ADELAIDE
• BRISBANE
• CARLTON
• MELBOURNE
• SOUTH YARRA
• SYDNEY
• WESTMEAD

Link to trial result