skip navigation

Skip Nav

Ensayos clínicos

Ensayos clínicos

Safety and Effectiveness of Raltegravir and Darunavir/Ritonavir in Treatment-Naive HIV-Infected Adults

Patrocinador(es) del estudio: AIDS Clinical Trials Group
Números de identificación: NCT00830804, ACTG A5262
  • Concluido

Propósito del estudio

The purpose of this study is to assess the effectiveness and safety an antiretroviral therapy (ART) regimen consisting of raltegravir (RAL) and darunavir (DRV)/ritonavir (RTV) as first-line therapy in treatment-naïve participants.

Afección:Fase:
HIV-1 Infections
Fase 2

Detalles del estudio

Despite the remarkable strides made in the treatment of HIV-1-infected persons over the last

decade, current first-line ART regimens are imperfect. The ideal combination, unlike some

current first-line options, would have uncompromised efficacy in the presence of transmitted

drug-resistant variants. The primary purpose of this study is to estimate the cumulative

proportion of ART-naive participants experiencing virologic failure after initiating a

regimen consisting of raltegravir (RAL) and darunavir/ritonavir (DRV/RTV).



The study will last 52 weeks. All participants will follow the same treatment schedule and

take RAL plus DRV/RTV orally daily for the duration of the trial.



After screening, all participants will have scheduled visits at Weeks 1, 4, 12, 36, 48, and

52. Medical/medication history, blood and urine collection, and liver function tests will

occur at screening. A targeted physical exam and concomitant medications history will occur

at all study visits. Blood and urine collection and liver function tests will occur at most

study visits. For females, a pregnancy test will occur at screening and study entry.



RAL and DTV will be provided by the study. RTV will not be provided by the study.Despite the remarkable strides made in the treatment of HIV-1-infected persons over the last

decade, current first-line ART regimens are imperfect. The ideal combination, unlike some

current first-line options, would have uncompromised efficacy in the presence of transmitted

drug-resistant variants. The primary purpose of this study is to estimate the cumulative

proportion of ART-naive participants experiencing virologic failure after initiating a

regimen consisting of raltegravir (RAL) and darunavir/ritonavir (DRV/RTV).



The study will last 52 weeks. All participants will follow the same treatment schedule and

take RAL plus DRV/RTV orally daily for the duration of the trial.



After screening, all participants will have scheduled visits at Weeks 1, 4, 12, 36, 48, and

52. Medical/medication history, blood and urine collection, and liver function tests will

occur at screening. A targeted physical exam and concomitant medications history will occur

at all study visits. Blood and urine collection and liver function tests will occur at most

study visits. For females, a pregnancy test will occur at screening and study entry.



RAL and DTV will be provided by the study. RTV will not be provided by the study.

Criterios de inclusión

    :
    • HIV-infected
    • Plasma HIV RNA of at least 5,000 copies/mL within 90 days prior to study entry
    • HIV genotype performed at any time prior to study entry. More information on this
    criterion can be found in the protocol.
    • ARV drug-naive. More information on this criterion can be found in the protocol.
    • Negative hepatitis B surface antigen test performed within 90 days prior to study
    entry
    • Agree to use one form of medically-accepted contraceptive throughout the study and
    for 60 days after stopping study treatment. More information on this criterion can be found in the protocol.

Criterios de exclusión

    :
    • Serious illness requiring systemic treatment and/or hospitalization that, in the
    opinion of the investigator, would interfere with the study
    • Screening HIV genotype obtained any time prior to study entry with more than one DRV
    RAM (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, I84V, and L89V) or L76 alone
    • Known major integrase inhibitor RAM(s), including N155H, Q148H/R/K, Y143C/R, and
    G140S
    • Severe renal insufficiency requiring hemodialysis or peritoneal dialysis
    • Treatment with immunomodulators within 30 days prior to study entry. More information
    on this criterion can be found in the protocol.
    • Current medications that are prohibited with any study medications. More information
    on this criterion can be found in the protocol.
    • Known allergy/sensitivity to study drugs or their formulations.
    • Active drug or alcohol use or dependence that, in the opinion of the investigator,
    would interfere with the study
    • Certain abnormal laboratory results. More information on this criterion can be found
    in the protocol.
    • Pregnant or breastfeeding

Centros de estudio/contactos

Alabama

    AlabamaTherapeutics CRS, Birmingham, Alabama, 35294, United States

California

    Stanford CRS, Palo Alto, California, 94304, United States

    Ucsd, Avrc Crs, San Diego, California, 92103, United States

    Ucsf Aids Crs, San Francisco, California, 94110, United States

Colorado

    University of Colorado Hospital CRS, Aurora, Colorado, 80045, United States

District of Columbia

    Georgetown University CRS, Washington, District of Columbia, 20007, United States

Illinois

    Northwestern University CRS, Chicago, Illinois, 60611, United States

Massachusetts

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

    Beth Israel Deaconess Med Center, Boston, Massachusetts, 02115, United States

Missouri

    Washington U CRS, St.Louis, Missouri, 63110, United States

New York

    AIDS Community Health Ctr. ACTG CRS, Rochester, New York, 14604, United States

North Carolina

    Unc Aids Crs, Chapel Hill, North Carolina, 27599, United States

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

Ohio

    Univ. of Cincinnati CRS, Cincinnati, Ohio, 45267-0405, United States

    Case CRS, Cleveland, Ohio, 44106, United States

    MetroHealth CRS, Cleveland, Ohio, 44109, United States

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

Pennsylvania

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

    University of Pittsburgh CTU, Pittsburgh, Pennsylvania, 15213, United States

Rhode Island

    The Miriam Hospital, Providence, Rhode Island, 02906, United States

Tennessee

    Vanderbilt Therapeutics CRS, Nashville, Tennessee, 37203, United States

Texas

    Houston AIDS Research Team, Houston, Texas, 77030, United States

Actualizado: 30 de abril del 2010

Volver arriba