BOSS Study: A Study of Fuzeon Using the Needle-Free Biojector 2000 in Patients With HIV-1 Infection

This study has been completed.
Sponsor:
Collaborator:
Trimeris
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00337701
First received: June 15, 2006
Last updated: September 22, 2014
Last verified: September 2014

June 15, 2006
September 22, 2014
June 2006
January 2007   (final data collection date for primary outcome measure)
Composite endpoint (pain, induration, nodules/cysts) [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Signs and symptoms associated with Fuzeon injections, based on a composite endpoint;incidence of individual signs and symptoms of ISR
Complete list of historical versions of study NCT00337701 on ClinicalTrials.gov Archive Site
AEs and ISRs [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Overall ISR summary score;AEs and ISR leading to discontinuation; SAEs; deaths; patient satisfaction/preference; adherence.
Not Provided
Not Provided
 
BOSS Study: A Study of Fuzeon Using the Needle-Free Biojector 2000 in Patients With HIV-1 Infection
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

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 patie nts experienced to Fuzeon treatment, but having difficulty tolerating long-term (>4 weeks) administration of Fuzeon with the standard needle and syringe. Patien ts 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 antic ipated time on study treatment is <3 months, and the target sample size is 100-5 00 individuals.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: enfuvirtide [Fuzeon]
    90mg sc bid by Biojector 2000 NFID for 8 weeks
  • Drug: enfuvirtide [Fuzeon]
    90mg sc bid by standard needle and syringe for 4 weeks, followed by 90mg sc bid by Biojector 2000 NFID for 4 weeks.
  • Experimental: 1
    Intervention: Drug: enfuvirtide [Fuzeon]
  • Experimental: 2
    Intervention: Drug: enfuvirtide [Fuzeon]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
326
January 2007
January 2007   (final data collection date for primary outcome measure)

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.
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00337701
ML19849
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Trimeris
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP