|
|
 |
|
 |
|
Trial information
BOSS Study: A Study of Fuzeon Using the Needle-Free Biojector 2000 in Patients With HIV-1 Infection
Status: Completed
Protocol number: ML19849
Sponsor: Hoffmann-La Roche; Trimeris Inc.
Company division: Pharmaceutical
Official Scientific Title: Biojector 2000 Open-Label Safety Study (BOSS) to evaluate signs and symptoms associated with a needle-free injection device for administration of Fuzeon to patients with HIV-1 infection
Brief summary: This study will evaluate the signs and symptoms associated with Fuzeon injection (90mg sc) using the B2000 needle-free injection device, in HIV-1 positive patients experienced to Fuzeon treatment, but having difficulty tolerating long-term (>4 weeks) administration of Fuzeon with the standard needle and syringe. Patients will be randomized to the B2000 device or the standard needle and syringe for 4 weeks; all patients will use the B2000 device for the next 4 weeks. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals. Target sample size is 300.
Study phase: IV
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety study
Condition: HIV Infections
Intervention type: Drug
Intervention name: enfuvirtide [Fuzeon]
Primary outcome: 1. Composite endpoint (pain, induration, nodules/cysts) Time frame: Throughout study
Key secondary outcomes: 1. AEs and ISRs Time frame: Throughout study
Inclusion criteria: - adult patients >=16 years of age;
- current or former Fuzeon user who may benefit from needle-free administration of Fuzeon;
- naive to use of the B2000 device;
- positive test results for human immunodeficiency virus infection.
Exclusion criteria: - patients naive to Fuzeon;
- inability to self-inject Fuzeon, or no reliable caregiver to administer injections;
- evidence of active, untreated, opportunistic infections.
Gender: Males or Females
Age limits: Min: 16 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 06/16/2006
Date last updated: 10/15/2008
Link to trial result
This trial was conducted at the following locations:United States - Birmingham, AL
- Phoenix, AZ
- Fountain Valley, CA
- Hayward, CA
- Long Beach, CA
- Los Angeles, CA
- Palm Springs, CA
- San Francisco, CA
- Santa Clara, CA
- Denver, CO
- Fort Lauderdale, FL
- Fort Myers, FL
- North Miami Beach , FL
- Orlando, FL
- Plantation, FL
- Port St Lucie, FL
- Atlanta, GA
- Decatur, GA
- Boise, ID
- Chicago, IL
- Baltimore, MD
- Silver Spring, MD
- Boston, MA
- St Louis, MO
- Somers Point, NJ
- Voorhees, NJ
- New York, NY
- Rochester, NY
- Winston-Salem, NC
- Portland, OR
- Philadelphia, PA
- Ponce, PR
- Santurce, PR
- Fort Worth, TX
- Galveston, TX
- Houston, TX
- Hampton, VA
- Spokane , WA
|
|
 |
|
