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A Study Comparing the Efficacy and Safety of Once-Daily Fuzeon (Enfuvirtide) Dosing Versus the Currently Recommended Twice-Daily Dosing in Human Immunodeficiency Virus-Type 1 (HIV-1) Infected Patients

This study has been completed.
Sponsor:
Collaborator:
Trimeris
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00089492
First received: August 5, 2004
Last updated: November 3, 2014
Last verified: November 2014

August 5, 2004
November 3, 2014
July 2004
June 2006   (final data collection date for primary outcome measure)
Viral load.\n\n [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00089492 on ClinicalTrials.gov Archive Site
  • CD4 lymphocyte count. [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  • AEs, laboratory abnormalities, local injection site reactions, AIDS-defining events.\n [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
A Study Comparing the Efficacy and Safety of Once-Daily Fuzeon (Enfuvirtide) Dosing Versus the Currently Recommended Twice-Daily Dosing in Human Immunodeficiency Virus-Type 1 (HIV-1) Infected Patients
A Phase II Open-label, Randomized, Active-controlled Study Comparing the Efficacy and Safety of Once Daily Enfuvirtide Dosing Versus the Currently Recommended Twice Daily Dosing in HIV-1 Infected Treatment-experienced Patients.

This study will assess the safety and efficacy of once-daily administration of F uzeon compared with twice-daily administration in HIV-1 infected patients who ha ve received prior treatment. Patients will also receive an optimized treatment c onsisting of antiretroviral (ARV) therapy as determined by the treating physicia n. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: enfuvirtide [Fuzeon]
    180mg sc once daily for 48 weeks
  • Drug: enfuvirtide [Fuzeon]
    90mg sc bid for 48 weeks
  • Drug: Optimized Background ARVs
    As prescribed
  • Experimental: 1
    Interventions:
    • Drug: enfuvirtide [Fuzeon]
    • Drug: Optimized Background ARVs
  • Active Comparator: 2
    Interventions:
    • Drug: enfuvirtide [Fuzeon]
    • Drug: Optimized Background ARVs
Wright D, Rodriguez A, Godofsky E, Walmsley S, Labriola-Tompkins E, Donatacci L, Shikhman A, Tucker E, Chiu YY, Chung J, Rowell L, Demasi R, Graham N, Salgo M. Efficacy and safety of 48 weeks of enfuvirtide 180 mg once-daily dosing versus 90 mg twice-daily dosing in HIV-infected patients. HIV Clin Trials. 2008 Mar-Apr;9(2):73-82.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
June 2006
June 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • HIV-1 infected adults or adolescents >=16 years of age;
  • HIV-1 RNA >=5000 copies/mL;
  • prior experience or documented resistance to each of the 3 currently available classes of ARV drugs (nucleoside reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors, and protease inhibitors).

Exclusion Criteria:

  • history of prior use of Fuzeon or T-1249;
  • female patients who are pregnant or breastfeeding, or who plan to become pregnant during the study;
  • current severe illness;
  • currently taking drugs affecting the immune system, HIV vaccine, or investigational agents for any conditions other than HIV/AIDS.
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Puerto Rico
 
NCT00089492
NV17658
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Trimeris
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2014

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