Trial information
OPTIONS Study: A Study of Three Delivery Mechanisms for Fuzeon.
Status: No longer recruiting
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 60.
Study phase: IV
Study type: Interventional; Treatment; Randomized; Open Label; Active; Crossover; Safety/Efficacy study
Condition: 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: 05/04/2006
Date last updated: 10/15/2008
Link to trial result
This trial was conducted at the following locations:
Australia
- Adelaide
- Brisbane
- Carlton
- Melbourne
- South Yarra
- Sydney
- Westmead
