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Ensayos clínicos

Ensayos clínicos

A Study on Amprenavir in Combination with Other Anti-HIV Drugs in HIV-Positive Patients

Patrocinador(es) del estudio: National Institute of Allergy and Infectious Diseases (NIAID)
Números de identificación: NCT00000912, ACTG 398
  • Concluido

Propósito del estudio

To determine how many patients achieve plasma HIV-1 RNA concentrations of less than 200 copies/ml across 4 study arms by Week 24. To compare the time to quantifiable viremia (at least 200 copies/ml of plasma HIV-1 RNA) across the arms of the study. To compare safety and tolerance of treatment across the study arms.

Afección:Fase:
Infecciones por el VIH
Fase 2

Detalles del estudio

A number of studies both within and outside the ACTG have been initiated or are in development to try to address the issue of alternative treatments for patients who either do not achieve or lose virologic control while receiving protease inhibitors (PIs). Amprenavir (APV) is an attractive candidate to investigate as part of salvage regimens because: 1) it has substantial antiretroviral activity; 2) there are preliminary in vitro and in vivo data that suggest that resistance to this agent may be mediated in part by a unique mutation (I50V); and 3) its cross-resistance profile to the approved PIs is uncertain.Patients are selectively randomized to 1 of 4 study arms based on prior PI experience. Those randomized to Arms A, B, or C receive 2 PIs, 1 of which is amprenavir (APV), and those randomized to Arm D receive a single PI (APV) as part of their treatment regimen, as follows: Arm A: APV plus saquinavir soft gel capsule (SQVsgc) plus abacavir (ABC) plus efavirenz (EFV) plus adefovir (ADV). Arm B: APV plus indinavir (IDV) plus ABC plus EFV plus ADV. Arm C: APV plus nelfinavir (NFV) plus ABC plus EFV plus ADV. Arm D: APV plus placebo (NFV, IDV, or SQVsgc) plus ABC plus EFV plus ADV. All patients receive L-carnitine supplementation. All patients receive clinical physical assessments and laboratory testing during study as follows: Weeks 2, 4, and every 4 weeks thereafter. A primary analysis is performed after the last patient has reached 24 weeks. [AS PER AMENDMENT 3/2/00: At that time, all patients are unblinded to their original treatment assignment.] Patients who experience virologic failure are unblinded and may choose 1 of the following 3 options: Continue study medications open-label, permanently discontinue study medications, or selectively continue study medications [AS PER AMENDMENT 3/2/00: from the arm the patient was originally randomized to] and combine with other approved antiretroviral agents. [AS PER AMENDMENT 3/2/00: For patients adding didanosine (ddI) to their regimens, monitoring for the development of pancreatitis is crucial.] Final evaluations are required for those patients who are off drug during the immediate 8-week period following the last dose of study treatment. Beyond 8 weeks, they are followed for incidence of death, cancer, congenital anomalies, and permanent disabilities. [AS PER AMENDMENT 3/2/00: Gilead Sciences has terminated its U.S. development of ADV for HIV infection. Gilead will continue to supply ADV for patients in ACTG 398 until the study closes. Patients who are receiving ADV at the completion of the study may continue to access ADV through the Expanded Access Program, provided that the physician and patient have determined that continued use of ADV is beneficial.]

Criterios de exclusión

    Patients will not be eligible for this study if they: Have hepatitis within 90 days prior to study entry. Have a history of a peripheral neuropathy within 60 days of study entry. Have an unexplained temperature for a 7-day period. Have chronic diarrhea within 30 days prior to study entry. Have cancer requiring chemotherapy. Received any therapy for infection or other illness within 30 days prior to study entry. Have received certain other medications. Are pregnant or breast-feeding.

Centros de estudio/contactos

California

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

    USC Univ Hosp & Ambulatory Hlth Care Ctr / USC Med Ctr, Los Angeles, California, 900334508, United States

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

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

    Univ of California / San Diego Treatment Ctr, San Diego, California, 921036325, United States

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

    San Francisco AIDS Clinic / 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

    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

    Emory Hemo Comp Evaluation Clinic / East TN Comp Hemo Ctr, Atlanta, Georgia, 303652225, United States

Hawaii

    Queens Med Ctr, Honolulu, Hawaii, 96816, United States

    Univ of Hawaii, Honolulu, Hawaii, 96816, United States

    Tripler Army Med Ctr, Tripler AMC, Hawaii, 96859, 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

Louisiana

    Charity Hosp / Tulane Univ Med School, New Orleans, Louisiana, 70112, United States

    Tulane Univ School of Medicine, New Orleans, Louisiana, 70112, United States

Maryland

    Johns Hopkins Hosp, Baltimore, Maryland, 21287, United States

Massachusetts

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

    Boston Med Ctr, Boston, Massachusetts, 02118, United States

Minnesota

    Univ of Minnesota, Minneapolis, Minnesota, 55455, 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

    Mem Sloan - Kettering Cancer Ctr, New York, New York, 10021, 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

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

North Carolina

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

    Moses H Cone Memorial Hosp, Greensboro, North Carolina, 27401, United States

Ohio

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

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

Pennsylvania

    Milton S Hershey Med Ctr, Hershey, Pennsylvania, 170330850, United States

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

    Univ of Pittsburgh Med Ctr, Pittsburgh, Pennsylvania, 15213, United States

Texas

    Univ of Texas Galveston, Galveston, Texas, 775550435, United States

Washington

    Univ of Washington, Seattle, Washington, 981224304, United States

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

Actualizado: 13 de octubre del 2004

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