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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.

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ClinicalTrials.gov Identifier: NCT00461266
Recruitment Status : Withdrawn (Slow recruitment)
First Posted : April 17, 2007
Last Update Posted : August 24, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
HIV Infections Drug: enfuvirtide [Fuzeon] Drug: Antiretroviral therapy Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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
Study Start Date : April 2007
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Enfuvirtide

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 Drug: enfuvirtide [Fuzeon]
90mg sc bid

Drug: Antiretroviral therapy
As prescribed
Active Comparator: 2 Drug: Antiretroviral therapy
As prescribed


Outcome Measures
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Primary Outcome Measures :
  1. Mean change in CD4 cell count from baseline [ Time Frame: Week 24 ]

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00461266     History of Changes
Other Study ID Numbers: ML19355
First Posted: April 17, 2007    Key Record Dates
Last Update Posted: August 24, 2016
Last Verified: August 2016

Keywords provided by Hoffmann-La Roche:
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
 Enfuvirtide
HIV Fusion Inhibitors
Viral Fusion Protein Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents