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Assess the Downregulation of HIV-1 When Raltegravir is Added to a Virologically Suppressed HAART Regimen

Sponsor
National Jewish Health (Other)
Overall Status
Completed
CT.gov ID
NCT00738569
Collaborator
Merck Sharp & Dohme LLC (Industry)
30
Enrollment
1
Location
1
Arm
31
Actual Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether or not adding Raltegravir to a fully suppressive antiretroviral regimen will assist in reducing HIV-1 associated chronic inflammation and increase the t-lymphocyte memory cell pool.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
A Pilot Study to Assess the Downregulation of HIV-1 Associated Chronic Inflammation in Patients With Limited Immunologic Responses When Raltegravir is Added to a Virologically Suppressed HAART Regimen
Actual Study Start Date :
Jul 1, 2008
Actual Primary Completion Date :
Feb 1, 2011
Actual Study Completion Date :
Feb 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: Raltegravir

Drug: Raltegravir
Raltegravir 400 mg PO BID for 12 months
Other Names:
  • Brand name is Isentress

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Quantitative changes in activated CD4+/CD8+ T-lymphocytes, pro-inflammatory cytokines and the central memory cell pool [12 months]

    Secondary Outcome Measures

    1. Measure the change in circulating CD4+ and CD8+ T-lymphocytes [12 months]

    2. Determine whether the circulating CD8+ T-lymphocyte count or the CD4+/CD8+ ratio can serve as a surrogate marker for suppression of chronic inflammation [12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. At least 18 years of age

    2. HIV-positive by Western blot or viral load

    3. Viral load < 400 copies/ml

    4. CD4+ T-lymphocyte count less than 350 cells/mm3 or change in CD4+ T-lymphocyte count < 100 cells/mm3 for at least one year on stable HAART with viral load < 400 copies/ml for the same period of time

    Exclusion Criteria:

    1. CD4+ T-lymphocyte count greater than or equal to 350 cells/mm3 or rise in CD4+ T-lymphocyte count greater than or equal to 100 cells/mm3 within one year of study entry

    2. Viral load > 400 copies/ml

    3. Allergy or resistance to raltegravir

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Jewish Health Denver Colorado United States 80206

    Sponsors and Collaborators

    • National Jewish Health
    • Merck Sharp & Dohme LLC

    Investigators

    • Principal Investigator: Kenneth A Lichtenstein, MD, National Jewish Health

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Jewish Health
    ClinicalTrials.gov Identifier:
    NCT00738569
    Other Study ID Numbers:
    • Merck HIV
    First Posted:
    Aug 20, 2008
    Last Update Posted:
    Jan 19, 2021
    Last Verified:
    Jan 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by National Jewish Health
    Chronic inflammation
    memory cells
    activated t-lymphocytes
    Additional relevant MeSH terms:
    Raltegravir Potassium

    Study Results

    No Results Posted as of Jan 19, 2021