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ESP Study: A Study to Assess the Effect of Adding Fuzeon (Enfuvirtide) to an Antiretroviral Regimen in Fuzeon-Naive Patients With Sustained HIV Viral Suppression.

This study has been terminated.
(Slow recruitment)
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00461266
First received: April 16, 2007
Last updated: March 19, 2008
Last verified: March 2008

April 16, 2007
March 19, 2008
Not Provided
Not Provided
Mean change in CD4 cell count from baseline [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Mean change in CD4 cell count from baseline at week 24.
Complete list of historical versions of study NCT00461266 on ClinicalTrials.gov Archive Site
  • Change in HIV RNA from baseline [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Change in HIV RNA and CD4 cell count [ Time Frame: Weeks 24-48 ] [ Designated as safety issue: No ]
  • Correlation between CD4 count and HIV RNA; OIs; QoL; ADEs; SAEs. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Efficacy: Change in HIV RNA from baseline at week 24; change in HIV RNA and CD4 cell count between weeks 24 and 48; correlation between CD4 count and HIV RNA; OIs; QoL. Safety: AIDS-defining events; SAEs.
Not Provided
Not Provided
 
ESP Study: A Study to Assess the Effect of Adding Fuzeon (Enfuvirtide) to an Antiretroviral Regimen in Fuzeon-Naive Patients With Sustained HIV Viral Suppression.
A Randomized, Open Label Study to Determine the Immunological Benefits of Adding Fuzeon to an Antiretroviral Regimen in HIV-Infected Fuzeon-naïve Patients With Sustained HIV Viral Suppression

This 2 arm study will assess the immunological benefits of adding Fuzeon to an antiretroviral regimen in HIV-infected, Fuzeon-naive patients with a CD4 cell count <250 cells/mm3 and an HIV RNA viral load <400 copies/mL. Eligible patients will be randomized to receive Fuzeon 90mg bid sc in addition to their current antiretroviral therapy, or to continue their current antiretroviral therapy alone. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: enfuvirtide [Fuzeon]
    90mg sc bid
  • Drug: Antiretroviral therapy
    As prescribed
  • Experimental: 1
    Interventions:
    • Drug: enfuvirtide [Fuzeon]
    • Drug: Antiretroviral therapy
  • Active Comparator: 2
    Intervention: Drug: Antiretroviral therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
40
May 2009
Not Provided

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • documented chronic HIV infection;
  • currently receiving a stable antiretroviral regimen;
  • CD4 cell count <250 cells/mm3;
  • HIV RNA viral load <400 copies/mL for >12 months.

Exclusion Criteria:

  • prior exposure to Fuzeon;
  • prior non-adherence to antiretroviral treatment regimens;
  • active opportunistic infection;
  • currently taking, or anticipated to take during the study, any immunomodulator.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00461266
ML19355
Not Provided
Clinical Trials, Study Director, Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
March 2008

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