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Ensayos clínicos

Ensayos clínicos

A Study to Compare The Ability of Different Anti-HIV Drugs to Decrease Viral Load After Nelfinavir (an Anti-HIV Drug)Treatment Failure

Patrocinador(es) del estudio: National Institute of Allergy and Infectious Diseases (NIAID)
Números de identificación: NCT00000918, ACTG 400
  • Concluido

Propósito del estudio

To assess the number of patients who achieve undetectable HIV RNA levels after 48 weeks of treatment in one of 4 treatment groups. To determine how long viral suppression lasts. To determine the safety and tolerance of these combination therapy regimens.

Afección:Fase:
Infecciones por el VIH
Fase 2

Detalles del estudio

To maximize the likelihood of a favorable response to salvage therapy, 4 or 5 drug regimens should be studied. Regimens containing fewer drugs, particularly those lacking a non-nucleoside reverse transcriptase inhibitor (NNRTI) such as efavirenz, are likely to result in an unacceptable rate of virological failure. Therefore, this study examines drug combinations which include two new nucleoside reverse transcriptase inhibitors (NRTIs), the NNRTI efavirenz, and either one or two protease inhibitors which are known not to produce cross-resistance to nelfinavir.Patients are randomly selected to receive 1 of the following 4 treatment regimens: Arm A: Ritonavir, saquinavir, efavirenz, and 2 new NRTIs. Arm B: Indinavir, efavirenz and 2 new NRTIs. Arm C: Amprenavir, efavirenz, and 2 new NRTIs. [AS PER AMENDMENT 3/22/00: Patients have the option to increase the APV dose or to add low-dose ritonavir. APV will continue to be provided by the study; ritonavir will not be provided by the study.] Arm D: Indinavir, amprenavir, efavirenz, and 2 new NRTIs. [AS PER AMENDMENT 6/28/99: All treatment regimens must include at least 1 new NRTI.] [AS PER AMENDMENT 3/22/00: ACTG 400 will continue to provide originally randomized study medications to all patients until approximately May 10, 2000, regardless of virologic response. Patients may also add antiretrovirals of their choice to this regimen (not provided by the study).] Clinical assessments are taken at Weeks 2, 4, 8, 12, 16, and every 8 weeks thereafter for the duration of the study. In addition, 2 substudies are being conducted: a drug-interaction substudy and a drug-exposure substudy. [AS PER AMENDMENT 3/22/00: Both substudies are closed to accrual and their pharmacokinetics assessments are discontinued.]

Criterios de exclusión

    Patients will not be eligible for this study if they: Have a fever for 7 days or diarrhea for 30 days before study entry. Have a history of peripheral neuropathy within 60 days of study entry. Have hepatitis. Have any malignancy (cancer) other than minimal Kaposi's sarcoma. Are pregnant or breast-feeding. Are receiving radiation, chemotherapy, or any therapy for any illness within 14 days of study entry. Have taken amprenavir, saquinavir, indinavir or ritonavir for more than 7 days. Have received an HIV vaccine 30 days before study entry. Are receiving certain other medications.

Centros de estudio/contactos

Alabama

    Univ of Alabama at Birmingham, Birmingham, Alabama, 35294, United States

California

    Univ of Southern California / LA County USC Med Ctr, Los Angeles, California, 900331079, United States

    UCLA CARE Ctr, Los Angeles, California, 90095, United States

    Willow Clinic, Menlo Park, California, 94025, United States

    San Francisco AIDS Clinic / San Francisco Gen Hosp, San Francisco, California, 941102859, United States

    San Francisco Gen Hosp, San Francisco, California, 941102859, United States

    Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium, San Jose, California, 951282699, United States

    Marin County Specialty Clinic, San Rafael, California, 94903, United States

    Stanford Univ Med Ctr, Stanford, California, 943055107, United States

    San Mateo AIDS Program / Stanford Univ, Stanford, California, 943055107, United States

Colorado

    Univ of Colorado Health Sciences Ctr, Denver, Colorado, 80262, United States

District of Columbia

    Howard Univ, Washington, District of Columbia, 20059, United States

Florida

    Univ of Miami School of Medicine, Miami, Florida, 331361013, United States

Georgia

    Emory Univ, Atlanta, Georgia, 30308, United States

Illinois

    Northwestern Univ Med School, Chicago, Illinois, 60611, United States

    Rush Presbyterian - Saint Luke's Med Ctr, Chicago, Illinois, 60612, United States

    Cook County Hosp, Chicago, Illinois, 60612, United States

Indiana

    Indiana Univ Hosp, Indianapolis, Indiana, 462025250, United States

    Methodist Hosp of Indiana / Life Care Clinic, Indianapolis, Indiana, 46202, United States

    Division of Inf Diseases/ Indiana Univ Hosp, Indianapolis, Indiana, 46202, United States

Massachusetts

    Harvard (Massachusetts Gen Hosp), Boston, Massachusetts, 02114, United States

    Beth Israel Deaconess - West Campus, Boston, Massachusetts, 02215, United States

Missouri

    St Louis Regional Hosp / St Louis Regional Med Ctr, St Louis, Missouri, 63112, United States

New York

    SUNY / Erie County Med Ctr at Buffalo, Buffalo, New York, 14215, United States

    Bellevue Hosp / New York Univ Med Ctr, New York, New York, 10016, United States

    Mount Sinai Med Ctr, New York, New York, 10029, United States

    Cornell Univ Med Ctr, New York, New York, 10021, United States

    Chelsea Ctr, New York, New York, 10021, United States

    Beth Israel Med Ctr, New York, New York, 10003, United States

    Univ of Rochester Medical Center, Rochester, New York, 14642, United States

North Carolina

    Univ of North Carolina, Chapel Hill, North Carolina, 275997215, United States

    Duke Univ Med Ctr, Durham, North Carolina, 27710, United States

Ohio

    Univ of Cincinnati, Cincinnati, Ohio, 452670405, United States

    Case Western Reserve Univ, Cleveland, Ohio, 44106, United States

    Ohio State Univ Hosp Clinic, Columbus, Ohio, 432101228, United States

Pennsylvania

    Univ of Pennsylvania at Philadelphia, Philadelphia, Pennsylvania, 19104, United States

South Carolina

    Julio Arroyo, West Columbia, South Carolina, 29169, United States

Washington

    Univ of Washington, Seattle, Washington, 98104, United States

    Univ of Puerto Rico, San Juan, Washington, 009365067, Puerto Rico

Actualizado: 13 de octubre del 2004

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