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Ensayos clínicos

Ensayos clínicos

Nine Month Course of Anti-HIV Medications for People Recently Infected With HIV

Patrocinador(es) del estudio: AIDS Clinical Trials Group
Números de identificación: NCT00090779, AIEDRP AIN503/ ACTG A5217
  • Terminado

Propósito del estudio

Although some doctors favor starting anti-HIV treatment as soon as possible after patients learn they are infected, it is not known if treatment for recently infected patients results in long-term benefits or harm. The purpose of this study is to learn whether or not people should take anti-HIV drugs when they are first infected.

Afección:Fase:
Infecciones por el VIH
Fase 2

Detalles del estudio

Combination antiretroviral therapy has resulted in significantly decreased morbidity and

mortality, incidence of opportunistic infections, and hospitalizations in HIV infected

people. However, because of long-term toxicities associated with long-term use of

antiretrovirals and the persistence of virus in latent reservoirs, it is unclear when it is

best to initiate therapy in recently infected individuals. This study will compare the

virologic outcomes of adults recently infected with HIV who receive emtricitabine/tenofovir

disoproxil fumarate (FTC/TDF), coformulated as Truvada, and lopinavir/ritonavir (LPV/RTV),

coformulated as Kaletra, with those who receive no treatment.

This study will last 96 weeks. Participants will be randomly assigned to one of two groups.

For the first 36 weeks of the study, Group 1 will receive FTC/TDF once daily and LPV/RTV

twice daily. Some Group 1 participants will receive a different ART regimen as determined by

the participant and study staff, if appropriate. Group 2 will receive no treatment for the

duration of the study. At Week 37, participants from both Group 1 and 2 will be offered

treatment continuation or initiation until Week 96 if they have a high viral load, low CD4

count, or are experiencing HIV-related symptoms. Study visits will occur at screening, Weeks

1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 37, 38, 40, and every 4 weeks thereafter. Clinical

assessment and blood collection will occur at all visits. Urine tests will occur at selected

visits. Participants will be asked to complete an adherence questionnaire at Weeks 12, 24,

and 36.

Participants enrolled in this study are strongly encouraged to also enroll in the AIEDRP

CORE01 study.Combination antiretroviral therapy has resulted in significantly decreased morbidity and

mortality, incidence of opportunistic infections, and hospitalizations in HIV infected

people. However, because of long-term toxicities associated with long-term use of

antiretrovirals and the persistence of virus in latent reservoirs, it is unclear when it is

best to initiate therapy in recently infected individuals. This study will compare the

virologic outcomes of adults recently infected with HIV who receive emtricitabine/tenofovir

disoproxil fumarate (FTC/TDF), coformulated as Truvada, and lopinavir/ritonavir (LPV/RTV),

coformulated as Kaletra, with those who receive no treatment.

This study will last 96 weeks. Participants will be randomly assigned to one of two groups.

For the first 36 weeks of the study, Group 1 will receive FTC/TDF once daily and LPV/RTV

twice daily. Some Group 1 participants will receive a different ART regimen as determined by

the participant and study staff, if appropriate. Group 2 will receive no treatment for the

duration of the study. At Week 37, participants from both Group 1 and 2 will be offered

treatment continuation or initiation until Week 96 if they have a high viral load, low CD4

count, or are experiencing HIV-related symptoms. Study visits will occur at screening, Weeks

1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 37, 38, 40, and every 4 weeks thereafter. Clinical

assessment and blood collection will occur at all visits. Urine tests will occur at selected

visits. Participants will be asked to complete an adherence questionnaire at Weeks 12, 24,

and 36.

Participants enrolled in this study are strongly encouraged to also enroll in the AIEDRP

CORE01 study.

Criterios de inclusión

    for Step 1: Recently infected with HIV CD4 count of 350 cells/mm3 or more AND a CD4% of 14% or more within 21 days prior to study entry HIV viral load of 500 copies/ml or more within 21 days prior to study entry Ability and willingness to follow protocol requirements Willing to use acceptable forms of contraception

Criterios de exclusión

    for Step 1: Prior antiretroviral therapy. Participants who took antiretrovirals for postexposure prophylaxis more than one year prior to study entry are not excluded. CDC category B or C HIV disease History of pancreatitis Certain medications within 21 days prior to study entry. Participants who agree to receive an alternative ART regimen approved by the investigator will not be excluded. Previously received an investigational anti-HIV vaccine Current therapy with systemic corticosteroids. Patients who are taking a short course (less than 21 days) of corticosteroids are not excluded. Current therapy with systemic chemotherapeutic agents; nephrotoxic systemic agents; immunomodulatory treatments, including interleukin-2; or investigational agents Known allergy or sensitivity to study drugs or their formulations Current alcohol or drug use that, in the opinion of the investigator, would interfere with the study Serious medical or psychiatric illness that, in the opinion of the investigator, would interfere with the study Hepatitis B surface antigen positive within 21 days prior to study entry Known resistance to one or more components of the study drug regimen Pregnant or breastfeeding

Centros de estudio/contactos

California

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

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

    Harbor-UCLA Med. Ctr. CRS (603), Torrance, California, 90502, United States

Colorado

    University of Colorado Hospital CRS (6101), Aurora, Colorado, 80045, United States

Florida

    University of Miami AIDS CRS (901), Miami, Florida, 33139, United States

Georgia

    The Ponce de Leon Center CRS, Atlanta, Georgia, 30308, United States

Illinois

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

    Rush Univ. Med. Ctr. ACTG CRS (2702), Chicago, Illinois, 60612, United States

Indiana

    Indiana University Hospital (2601), Indianapolis, Indiana, 46202-5250, United States

Maryland

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

Massachusetts

    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

    HIV Prevention & Treatment CRS (30329), New York, New York, 10032, United States

    Beth Israel Medical Center, New York, New York, 10003, United States

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

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

North Carolina

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

    Moses H. Cone Memorial Hospital CRS (3203), Greensboro, North Carolina, 27401, United States

    Regional Center for Infectious Disease, Wendover Medical Center CRS (3203), Greensboro, North Carolina, 27401, United States

Ohio

    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

Rhode Island

    The Miriam Hosp. ACTG CRS (2951), Providence, Rhode Island, 02906, United States

Washington

    University of Washington AIDS CRS (1401), Seattle, Washington, 98104, United States

    UW Primary Infection Clinic CRS (1404), Seattle, Washington, 98104, United States

Lima

    San Miguel CRS, San Miguel, Lima, 98104, Peru

    Asociacion Civil Impacta Salud y Educacion - Miraf CRS (11301), Lima, Lima, 18 PE, Peru

Actualizado: 7 de diciembre del 2007

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