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Fuzeon Viral Decay Pilot Study

This study has been completed.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Canadian Immunodeficiency Research Collaborative
ClinicalTrials.gov Identifier:
NCT00334022
First received: June 2, 2006
Last updated: June 4, 2012
Last verified: June 2012
  Purpose

In order to better understand the source(s) and the mechanism(s) of HIV persistence and to potentially lead to further suppression of HIV from viral reservoirs, we propose to examine the effect of co-administration of enfuvirtide, an entry inhibitor of HIV, on diminution of the size of the viral reservoir in infected individuals who are receiving effective antiviral therapy for extended periods of time (> 5 years).


Condition Intervention
HIV-1
Drug: enfuvirtide

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Randomized Controlled Trial of Adding Enfuvirtide to Standard Combination Antiretroviral Therapy in HIV-infected Individuals With Full Virologic Suppression to Further Suppress Proviral HIV DNA

Resource links provided by NLM:


Further study details as provided by Canadian Immunodeficiency Research Collaborative:

Primary Outcome Measures:
  • The change of proviral HIV-1 DNA in both purified resting and activated CD4 T cells from baseline to month 6. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The change of proviral HIV-1 DNA in both purified resting and activated CD4 T cells from baseline to month 6.


Secondary Outcome Measures:
  • To determine the change of proviral HIV-1 DNA from baseline to month 3 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    To determine the change of proviral HIV-1 DNA from baseline to month 3

  • To determine the change of proviral HIV-1 DNA from months 6 to 9 after the enfurvitide has been stopped for 3 months in the treatment arm [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    To determine the change of proviral HIV-1 DNA from months 6 to 9 after the enfurvitide has been stopped for 3 months in the treatment arm

  • To quantify plasma HIV (limit of detection 2 copies/ml of plasma) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    To quantify plasma HIV (limit of detection 2 copies/ml of plasma)

  • To quantify cell associated HIV RNA (unspliced and multiply spliced) in resting and activated CD4+ T cells [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    To quantify cell associated HIV RNA (unspliced and multiply spliced) in resting and activated CD4+ T cells

  • To determine the decay characteristics of HIV in resting CD4+ T cells by quantitative co-culture assays [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    To determine the decay characteristics of HIV in resting CD4+ T cells by quantitative co-culture assays

  • To determine the half-life of HIV in resting CD4+ T cells [ Time Frame: 9months ] [ Designated as safety issue: No ]
    To determine the half-life of HIV in resting CD4+ T cells

  • To carry out phylogenetic analysis of HIV in the plasma, resting, and activated CD4+ T cell compartments [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    To carry out phylogenetic analysis of HIV in the plasma, resting, and activated CD4+ T cell

  • To quantify the amount of HIV in gastrointestinal-associated lymphoid tissue (GALT) by quantitative co-culture assays (as part of a sub-study - see GALT sub-study) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    To quantify the amount of HIV in gastrointestinal-associated lymphoid tissue (GALT) by quantitative co-culture assays (as part of a sub-study - see GALT sub-study)


Enrollment: 18
Study Start Date: February 2006
Study Completion Date: January 2010
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Did not receive enfuvirtide
patients were randomized to either receive enfuviratide or not receive it
Drug: enfuvirtide
1ml BID
Active Comparator: enfuvirtide
enfuvirtide 1ml BID
Drug: enfuvirtide
1ml BID

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient must be HIV infected
  2. Patient must be > 18 years old
  3. Patient must be taking standard combination antiretroviral therapy with 2-3 NRTIs and 1-2 PIs or a NNRTIs for at least five years
  4. Patient must have a viral load < 50 copies/mL (using the standard available methods of detection) during the entire time on standard combination antiretroviral therapy except for initial fall of viral load
  5. Patient must have a CD4 count above 400 cells/mm3 in last 3 months
  6. Female patient must agree to use two methods of birth control or abstinence during the period of the study
  7. Patient has to have signed full informed consent

Exclusion Criteria:

  1. Patient who would have difficulty participating in a trial due to non-adherence or substance abuse
  2. Patient who have taken mono or dual antiretroviral therapy
  3. Patient who have had a viral load > 50 copies/mL on any antiretroviral regimen
  4. Patient with any of the following abnormal laboratory test results in screening:

    • Hemaglobin < 100 g/L
    • Neutrophil count < 750 cells/uL
    • Platelet count < 50,000 cells/L
    • AST or ALT > 5X the upper limit of normal
    • Creatinine > 250 umol/L
  5. Patient with a malignancy
  6. Patient with other significant underlying disease (non-HIV) that might impinge upon disease progression or death
  7. Patient with an active AIDS-defining illnesses in the past six months
  8. Patients who are pregnant
  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: NCT00334022

Locations
Canada, Ontario
Maple Leaf Medical Clinic
Toronto, Ontario, Canada, M5B 1L6
Sponsors and Collaborators
Canadian Immunodeficiency Research Collaborative
Hoffmann-La Roche
Investigators
Principal Investigator: Colin Kovacs, MD University of Toronto
  More Information

No publications provided

Responsible Party: Canadian Immunodeficiency Research Collaborative
ClinicalTrials.gov Identifier: NCT00334022     History of Changes
Other Study ID Numbers: Roche-FVD-1
Study First Received: June 2, 2006
Last Updated: June 4, 2012
Health Authority: Canada: Health Canada

Keywords provided by Canadian Immunodeficiency Research Collaborative:
Fuzeon
Viral Decay

Additional relevant MeSH terms:
Enfuvirtide
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
HIV Fusion Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014