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

June 2, 2006
June 4, 2012
February 2006
July 2007   (final data collection date for primary outcome measure)
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.
The change of proviral HIV-1 DNA in both purified resting and activated CD4 T cells from baseline to month 6.
Complete list of historical versions of study NCT00334022 on ClinicalTrials.gov Archive Site
  • 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)
  • 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
  • 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
  • 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
  • To carry out phylogenetic analysis of HIV in the plasma, resting, and activated CD4+ T cell compartments
  • 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)
Not Provided
Not Provided
 
Fuzeon Viral Decay Pilot Study
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

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).

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV-1
Drug: enfuvirtide
1ml BID
  • Placebo Comparator: Did not receive enfuvirtide
    patients were randomized to either receive enfuviratide or not receive it
    Intervention: Drug: enfuvirtide
  • Active Comparator: enfuvirtide
    enfuvirtide 1ml BID
    Intervention: Drug: enfuvirtide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
January 2010
July 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00334022
Roche-FVD-1
Not Provided
Canadian Immunodeficiency Research Collaborative
Canadian Immunodeficiency Research Collaborative
Hoffmann-La Roche
Principal Investigator: Colin Kovacs, MD University of Toronto
Canadian Immunodeficiency Research Collaborative
June 2012

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