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Ensayos clínicos

Ensayos clínicos

Safety and Effectiveness of Addition of Maraviroc to ART Regimens in HIV-Infected Adults With Suboptimal CD4 T-Cell Count Recovery Despite Sustained Virologic Suppression

Patrocinador(es) del estudio: AIDS Clinical Trials Group
Números de identificación: NCT00709111, ACTG A5256
  • Concluido

Propósito del estudio

Some HIV-infected individuals with low viral load on antiretroviral therapy (ART) do not have increased CD4 counts and remains at risk for clinical progression of HIV. The purpose of this study is to assess whether adding maraviroc (MVC) to a stable ART regimen will result in an improved immune response in individuals with a limited CD4 response despite sustained virologic suppression..

Afección:
Infecciones por el VIH

Detalles del estudio

The majority of HIV-infected individuals with virologic suppression on antiretroviral therapy

(ART) have a significant increase in CD4 count over the first year. However, a portion of

these individuals show a suboptimal immune response and remain at an elevated risk for

clinical progression. The primary purpose of this study is to determine the effectiveness and

safety of the addition of maraviroc (MVC) to stable treatment regimens in individuals with

suboptimal immune response despite sustained virologic suppression.



This study will last approximately 48 weeks. All participants will add MVC to their current

antiretroviral drug regimen for 24 weeks. Dosage of MVC will depend on the regimen of each

participant. At Week 24, participants will discontinue MVC and be followed for an additional

24 weeks.



All participants will have study visits at study entry and Weeks 4, 8, 12, 16, 22, 24, 36,

46, and 48. A clinical assessment and blood collection will occur at all visits. A

questionnaire will take place at select visits. For women, a pregnancy test will occur at

study entry and Week 24. MVC will be distributed at study entry and Weeks 8 and 16. Other ART

will not be supplied by the study.The majority of HIV-infected individuals with virologic suppression on antiretroviral therapy

(ART) have a significant increase in CD4 count over the first year. However, a portion of

these individuals show a suboptimal immune response and remain at an elevated risk for

clinical progression. The primary purpose of this study is to determine the effectiveness and

safety of the addition of maraviroc (MVC) to stable treatment regimens in individuals with

suboptimal immune response despite sustained virologic suppression.



This study will last approximately 48 weeks. All participants will add MVC to their current

antiretroviral drug regimen for 24 weeks. Dosage of MVC will depend on the regimen of each

participant. At Week 24, participants will discontinue MVC and be followed for an additional

24 weeks.



All participants will have study visits at study entry and Weeks 4, 8, 12, 16, 22, 24, 36,

46, and 48. A clinical assessment and blood collection will occur at all visits. A

questionnaire will take place at select visits. For women, a pregnancy test will occur at

study entry and Week 24. MVC will be distributed at study entry and Weeks 8 and 16. Other ART

will not be supplied by the study.

Criterios de inclusión

    :
    • HIV-1 infection
    • Taking ART for at least 48 weeks prior to study entry with a regimen that includes
    three or more antiretroviral medications
    • No change in ART regimen for at least 24 weeks prior to study entry
    • CD4 count less than 250 within 60 days prior to study entry
    • Stable CD4 count for at least 48 weeks prior to study entry. More information on this
    criterion can be found in the protocol.
    • Documentation of CD4 count obtained within 14 days prior to study entry
    • Documentation of viral load less than the limit of detection. All viral load
    measurements within 48 weeks of study entry must be less than the limit of detection. More information on this criterion can be found in the protocol.
    • Confirmation of the availability of stored plasma sample obtained at the pre-entry
    visit
    • Confirmation that advanced lymphocyte flow cytometry has been performed within14 days
    prior to study entry
    • Females of reproductive potential. More information on this criterion can be found in
    the protocol.
    • Agree to use at least two forms of contraception while using study treatment and for
    the 6 weeks after stopping study treatment

Criterios de exclusión

    :
    • Unstable clinical condition. More information on this criterion can be found in the
    protocol.
    • Using immunomodulators within 12 months prior to study entry. More information on this
    criterion can be found in the protocol.
    • Acute AIDS-defining illness within 60 days prior to study entry
    • Known allergy/sensitivity or hypersensitivity to MVC
    • Active drug or alcohol abuse that, in the opinion of the investigator, would interfere
    with adherence to study regimens
    • Serious illness requiring systemic treatment and/or hospitalization within 60 days
    prior to study entry
    • Receipt of vaccine within 30 days prior to study entry
    • Current or previous use of a CCR5 inhibitor
    • Plan to change background ART regimen within 24 weeks after study entry
    • Receipt of experimental or non-experimental medications for the purpose of raising CD4
    counts within 6 months prior to study entry
    • Certain abnormal laboratory values. More information on this criterion can be found in
    the protocol.
    • Pregnant or breastfeeding

Centros de estudio/contactos

Alabama

    Alabama Therapeutics CRS (5801), Birmingham, Alabama, 35294, United States

California

    UCLA CARE Center CRS (601), Los Angeles, California, 90035, United States

    Stanford CRS (501), Palo Alto, California, 94304, United States

    Ucsd, Avrc Crs (701), San Diego, California, 92103, United States

    Ucsf Aids Crs (801), San Francisco, California, 94110, United States

District of Columbia

    Georgetown University CRS (GU CRS) (1008), Washington, District of Columbia, 20007, United States

Florida

    Univ. of Miami AIDS CRS (901), Miami, Florida, 33136, United States

Georgia

    The Ponce de Leon Ctr. CRS (5802), Atlanta, Georgia, 30308, United States

Illinois

    Northwestern University CRS (2701), Chicago, Illinois, 60611, United States

Maryland

    Johns Hopkins Adult AIDS CRS (201), Baltimore, Maryland, 21205, United States

    IHV Baltimore Treatment CRS (4651), Baltimore, Maryland, 21201, United States

Massachusetts

    Boston Medical Center ACTG CRS (104), Boston, Massachusetts, 02118, United States

    Brigham and Women's Hosp. ACTG CRS (107), Boston, Massachusetts, 02115, United States

    Massachusetts General Hospital ACTG CRS (101), Boston, Massachusetts, 02114, United States

Missouri

    Washington University CRS (2101), St. Louis, Missouri, 63110, United States

New York

    NY Univ. HIV/AIDS CRS (401), New York, New York, 10016, United States

    Cornell CRS (7804), New York, New York, 10011, United States

    AIDS Care CRS (1108), Rochester, New York, 14642, United States

    Univ. of Rochester ACTG CRS (1101), Rochester, New York, 14642, United States

North Carolina

    Unc Aids Crs (3201), Chapel Hill, North Carolina, 27516, United States

    Duke Univ. Med. Ctr. Adult CRS (1601), Durham, North Carolina, 27710, United States

Ohio

    Univ. of Cincinnati CRS (2401), Cincinnati, Ohio, 45267, United States

    MetroHealth CRS (2503), Cleveland, Ohio, 44109, United States

    The Ohio State Univ. AIDS CRS (2301), Columbus, Ohio, 43210, United States

Pennsylvania

    Hosp. of the Univ. of Pennsylvania CRS (6201), Philadelphia, Pennsylvania, 19104, United States

    Pittsburgh CRS (1001), Pittsburgh, Pennsylvania, 15213, United States

Tennessee

    Vanderbilt Therapeutics CRS (3652), Nashville, Tennessee, 37204, United States

Texas

    Peabody Health Ctr. CRS (31443), Dallas, Texas, 75215, United States

    Houston AIDS Research Team CRS (31473), Houston, Texas, 77030, United States

Actualizado: 19 de septiembre del 2008

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