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Ensayos clínicos

Ensayos clínicos

A Study to Compare Two Different Anti-HIV Drug Regimens

Patrocinador(es) del estudio: National Institute of Allergy and Infectious Diseases (NIAID)
Números de identificación: NCT00000924, ACTG 403
  • Concluido

Propósito del estudio

To evaluate combination treatment regimens consisting of didanosine (ddI) plus nelfinavir (NFV) plus ritonavir (RTV) or stavudine (d4T) plus nevirapine (NVP) plus NFV with respect to changes in plasma HIV-1 RNA levels. To evaluate the safety and tolerance of ddI/NFV/RTV and d4T/NVP/NFV. To evaluate individual pharmacokinetics and drug interactions in the first 8 patients in the ddI/NFV/RTV treatment arm.

Afección:Fase:
Infecciones por el VIH
Fase 2

Detalles del estudio

The use of combination therapy with 2 or more antiretroviral agents has been strongly supported by recent studies in both children and adults. However, as of yet, few combinations of antiretrovirals have been studied in large cohorts of stable HIV-1 infected, antiretroviral-experienced children. Evidence suggests that viral suppression may be more difficult to achieve in children. Therefore, it is important to develop new drug combinations which can maximally suppress plasma HIV-1 RNA concentrations in children.Patients are stratified by prior antiretroviral treatment (zidovudine [ZDV]/lamivudine [3TC] versus d4T/other treatment) and by age (under 24 months versus 24 months and older). Patients are then randomized to 1 of 4 treatment groups. Arm A1: ddI/NFV/RTV (for prior ZDV/3TC-treated patients). Arm A2: ddI/NFV/RTV (for prior d4T/other-treated patients). Arm B1: d4T/NFV/NVP (for prior ZDV/3TC-treated patients). Arm B2: d4T/NFV/NVP (for prior d4T/other-treated patients). Treatment is administered for 48 weeks. At Weeks 2, 4, and then every 4 weeks thereafter, patients undergo physical examinations, and blood samples are drawn to measure viral load. [AS PER AMENDMENT 4/27/00: Patients in Arms A1 and A2 may continue to receive medication for an additional 24 weeks. While on the treatment extension, patients must continue their current schedule for study drug administration and completion of study visits. Patients in Arms A1 and A2 who have reached Week 44 participate in an enteric-coated ddI pharmacokinetic study as part of this 24-week extension. Patients who were enrolled in Arms A1 or A2 and who were taken off study after reaching Week 48 may be re-entered onto the study at Week 52 regardless of the number of weeks they have been off study.]

Criterios de exclusión

    Patients will not be eligible for this study if they: Have an active opportunistic and/or serious bacterial infection. Have been diagnosed with a malignancy. Have received prior treatment with certain antiretroviral medications. Are pregnant or breast-feeding.

Centros de estudio/contactos

Alabama

    Univ of Alabama at Birmingham - Pediatric, Birmingham, Alabama, 35233, United States

    Univ of South Alabama, Mobile, Alabama, 36604, United States

California

    Long Beach Memorial (Pediatric), Long Beach, California, 90801, United States

    Harbor - UCLA Med Ctr / UCLA School of Medicine, Los Angeles, California, 905022004, United States

    Los Angeles County - USC Med Ctr, Los Angeles, California, 90033, United States

    Children's Hosp of Oakland, Oakland, California, 946091809, United States

    UCSF / Moffitt Hosp - Pediatric, San Francisco, California, 941430105, United States

District of Columbia

    Howard Univ Hosp, Washington, District of Columbia, 20060, United States

Florida

    North Broward Hosp District, Fort Lauderdale, Florida, 33311, United States

    Univ of Florida Gainesville, Gainesville, Florida, 32610, United States

    Univ of Miami (Pediatric), Miami, Florida, 33161, United States

Georgia

    Emory Univ Hosp / Pediatrics, Atlanta, Georgia, 30306, United States

Illinois

    Chicago Children's Memorial Hosp, Chicago, Illinois, 606143394, United States

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

    Univ of Chicago Children's Hosp, Chicago, Illinois, 606371470, United States

Louisiana

    Tulane Univ / Charity Hosp of New Orleans, New Orleans, Louisiana, 701122699, United States

    Earl K Long Early Intervention Clinic, New Orleans, Louisiana, 70112, United States

Maryland

    Univ of Maryland at Baltimore / Univ Med Ctr, Baltimore, Maryland, 21201, United States

    Johns Hopkins Hosp - Pediatric, Baltimore, Maryland, 212874933, United States

Massachusetts

    Children's Hosp of Boston, Boston, Massachusetts, 021155724, United States

    Baystate Med Ctr of Springfield, Springfield, Massachusetts, 01199, United States

    Univ of Massachusetts Med School, Worcester, Massachusetts, 016550001, United States

Michigan

    Children's Hosp of Michigan, Detroit, Michigan, 48201, United States

New Jersey

    Univ of Medicine & Dentistry of New Jersey / Univ Hosp, Newark, New Jersey, 071032714, United States

    Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl, Newark, New Jersey, 07103, United States

New York

    Bronx Municipal Hosp Ctr/Jacobi Med Ctr, Bronx, New York, 10461, United States

    Bronx Lebanon Hosp Ctr, Bronx, New York, 10457, United States

    North Shore Univ Hosp, Great Neck, New York, 11021, United States

    Schneider Children's Hosp, New Hyde Park, New York, 11040, United States

    Columbia Presbyterian Med Ctr, New York, New York, 10032, United States

    Harlem Hosp Ctr, New York, New York, 10037, United States

    Metropolitan Hosp Ctr, New York, New York, 10029, United States

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

    Incarnation Children's Ctr / Columbia Presbyterian Med Ctr, New York, New York, 10032, United States

    State Univ of New York at Stony Brook, Stony Brook, New York, 117948111, United States

    SUNY Health Sciences Ctr at Syracuse / Pediatrics, Syracuse, New York, 13210, United States

North Carolina

    Duke Univ Med Ctr, Durham, North Carolina, 277103499, United States

South Carolina

    Med Univ of South Carolina, Charleston, South Carolina, 294253312, United States

Tennessee

    Saint Jude Children's Research Hosp of Memphis, Memphis, Tennessee, 381052794, United States

Texas

    Children's Med Ctr of Dallas, Dallas, Texas, 75235, United States

Virginia

    Children's Hosp of the King's Daughters, Norfolk, Virginia, 23507, United States

    Med College of Virginia, Richmond, Virginia, 23219, United States

    Ramon Ruiz Arnau Univ Hosp / Pediatrics, Bayamon, Virginia, 00956, Puerto Rico

    San Juan City Hosp, San Juan, Virginia, 009367344, Puerto Rico

    Univ of Puerto Rico / Univ Children's Hosp AIDS, San Juan, Virginia, 009365067, Puerto Rico

Actualizado: 13 de octubre del 2004

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