Clinical Trial Protocol Registry
OPTIONS Study: A Study of Three Delivery Mechanisms for Fuzeon.
- Protocol number:
- Hoffmann-La Roche
- Company division:
- 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:
- Study type:
- Interventional; Treatment; Randomized; Open Label; Active; Crossover; Safety/efficacy study
- HIV Infections
- Intervention type:
- Intervention name:
- enfuvirtide [Fuzeon]
- Primary outcome:
- Injection site reactions (diameter, induration, erythema, swelling, pain, interference with normal activities, infection).
- Key secondary outcomes:
- 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.
- Males or Females
- Age limits:
- Min: 18 years Max: N/A (No limit)
- Accepts healthy volunteers:
- Anticipated start date:
- March, 2006
- Trial registration date:
- Date last updated:
- SOUTH YARRA
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