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Integrase Inhibitor (MK-0518) Viral Decay

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ClinicalTrials.gov Identifier: NCT00520897
Recruitment Status : Completed
First Posted : August 27, 2007
Last Update Posted : June 5, 2012
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Canadian Immunodeficiency Research Collaborative

Tracking Information
First Submitted Date  ICMJE August 24, 2007
First Posted Date  ICMJE August 27, 2007
Last Update Posted Date June 5, 2012
Study Start Date  ICMJE April 2007
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2012)
change of proviral HIV-1 DNA in total CD4+ T cells from baseline to week 48 [ Time Frame: 48 weeks ]
evaluate the change of proviral HIV-1 DNA in total CD4+ T cells from baseline to week 48 in participants randomized to the raltegravir arm (400mg raltegravir) for 48 weeks in addition to their current standard combination antiretroviral regimen versus the control arm, who remained on their current standard combination antiretroviral regimen.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00520897 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2012)
evaluated the effect of raltegravir intensification on blood CD4+ T cell populations [ Time Frame: 48 & 96 weeks ]
evaluated the effect of raltegravir intensification on blood CD4+ T cell populations. In addition, after treatment-intensification in both groups at week 48, a post-hoc follow-up of all participants was conducted up to week 96 to examine if raltegravir intensification had any long-term effects on proviral HIV DNA and CD4+ T cell populations in the blood and gut.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Integrase Inhibitor (MK-0518) Viral Decay
Official Title  ICMJE Effect of Integrase Inhibitor (MK-0518) on Decay of Low Level Viral Replication in HIV Reservoirs in Infected Individuals Who Initiated Conventional Antiretroviral Therapy During the Chronic Phase of Infection
Brief Summary The eradication of HIV by antiretroviral therapy has thus far been elusive. It has been consistently demonstrated that a pool of latently infected, resting CD4+ T cells persists in the majority of HIV-infected individuals receiving antiretroviral therapy in whom plasma viremia has been successfully suppressed for prolonged periods of time; this pool has emerged as the major obstacle in achieving the eradication of HIV. We believe that MK-0518 can further the decay and suppression of HIV-1 in patients who have been virologically suppressed for a prolonged period of time on effective cART (≥ 4 years).
Detailed Description The trial is a prospective, double-blind, randomized, placebo-controlled study with two phases: phase I to 48 weeks and phase II to 96 weeks with the primary analysis at 48 weeks. HIV-infected individuals who are taking their first standard cART regimen for at least four years with complete viral suppression. Upon enrollment, he/she will be randomized to one of two arms: the MK-0518 arm or the control arm. As each participant reaches week 48, he/she will be unblinded and those in the MK-0518 arm will continue taking MK-0518. Based on the results of an interim analysis, the control arm will be rolled over to receive MK-0518 for 48 weeks. After the screening, baseline visits and week 4 safety visit, follow-up visits will occur every 8 weeks for both arms.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE HIV Infections
Intervention  ICMJE
  • Drug: Raltegravir (MK0518)
    400mg BID; 48 weeks
  • Drug: Placebo
    400mg QD
  • Procedure: Leukopheresis
    pack of cells as per protocol
  • Procedure: Sigmoid Biopsy
    gut samples as per protocol
Study Arms  ICMJE
  • Experimental: MK0518 + cART
    Raltegravir + standard of care combined antiretroviral therapy
    Interventions:
    • Drug: Raltegravir (MK0518)
    • Procedure: Leukopheresis
    • Procedure: Sigmoid Biopsy
  • Placebo Comparator: Placebo + cART
    Placebo + standard of care combined antiretroviral therapy
    Interventions:
    • Drug: Placebo
    • Procedure: Leukopheresis
    • Procedure: Sigmoid Biopsy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 4, 2012)
24
Original Estimated Enrollment  ICMJE
 (submitted: August 24, 2007)
30
Actual Study Completion Date  ICMJE November 2011
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Participant must be HIV-1 infected
  2. Participant must be 18 years old
  3. Participant must be taking first standard cART with 2-3 NRTIs and 1-2 PIs or an NNRTI for at least four years (first cART regimen may include changes due to toxicity but not due to virologic failure).
  4. Participant must have a VL < 50 copies/ml (using the standard available methods of detection) during the entire time on standard cART except for initial fall of VL and a maximum of two non-consecutive blips of < 100 copies/ml that the study investigator deems to be not clinically significant
  5. Female participant must agree to use two methods of birth control or abstinence during the period of the study
  6. Participant has to have signed full informed consent

Exclusion Criteria:

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

    • Hemoglobin < 100 g/L
    • Neutrophil count < 750 cells/L
    • Platelet count < 50,000 cells/L
    • AST or ALT > 5X the upper limit of normal
    • Creatinine > 250 mol/L
  5. Participant with a malignancy
  6. Participant with other significant underlying disease (non-HIV) that might impinge upon disease progression or death
  7. Participant with an active AIDS-defining illness in the past six months
  8. Participant who is pregnant
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00520897
Other Study ID Numbers  ICMJE 038-00
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Canadian Immunodeficiency Research Collaborative
Study Sponsor  ICMJE Canadian Immunodeficiency Research Collaborative
Collaborators  ICMJE National Institutes of Health (NIH)
Investigators  ICMJE
Principal Investigator: Mona Loutfy, MD Women's College Hospital
PRS Account Canadian Immunodeficiency Research Collaborative
Verification Date June 2012

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