Clinical Trials

MainTitle

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This study has been withdrawn
Sponsor
Hoffmann-La Roche


Information provided by (Responsible Party)
Hoffmann-La Roche
ClinicalTrials.gov Identifier
NCT00461266

First received: April 16, 2007
Last updated: August 23, 2016
Last Verified: August 2016
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
HIV Infections

Drug : enfuvirtide [Fuzeon]
Drug : Antiretroviral therapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures

  • Mean change in CD4 cell count from baseline [ Time Frame: Week 24 ]
Secondary Outcome Measures:
  • Change in HIV RNA from baseline [ Time Frame: Week 24 ]
  • Change in HIV RNA and CD4 cell count [ Time Frame: Weeks 24-48 ]
  • Correlation between CD4 count and HIV RNA; OIs; QoL; ADEs; SAEs. [ Time Frame: Throughout study ]

Enrollment: 0
Study Start Date: April 2007
Study Completion Date: January 2008
Estimated Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: 1

Drug: enfuvirtide [Fuzeon]

90mg sc bid

Drug: Antiretroviral therapy

As prescribed

Active Comparator: 2

Drug: Antiretroviral therapy

As prescribed

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

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.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00461266

Locations

Australia
Carlton, Australia
Darlinghurst, Australia
Melbourne, Australia
Miami, Australia
Perth, Australia
South Yarra, Australia
Sydney, Australia

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director: Clinical Trials Hoffmann-La Roche
More Information

More Information


Responsible Party: Hoffmann-La Roche  
ClinicalTrials.gov Identifier: NCT00461266   History of Changes  
Other Study ID Numbers: ML19355  
Study First Received: April 16, 2007  
Last Updated: August 23, 2016  

Keywords provided by Hoffmann-La Roche:

Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Enfuvirtide

ClinicalTrials.gov processed this data on December 18, 2017
This information is provided by ClinicalTrials.gov.