skip navigation

Skip Nav

Ensayos clínicos

Ensayos clínicos

A Study on the Management of Combination Anti-HIV Drug Therapy in HIV-Positive Children with Prior Treatment

Patrocinador(es) del estudio: National Institute of Allergy and Infectious Diseases (NIAID)
Números de identificación: NCT00000902, ACTG 366
  • Concluido

Propósito del estudio

To determine the proportion of patients in each group having reduction in HIV-1 RNA when all antiretroviral drugs are changed and at least 2 of the drugs are novel; and to determine the duration of the reduction. To evaluate the safety and tolerance of these combination drugs based on clinical and laboratory toxicities. To determine the steady-state pharmacokinetics of nevirapine, nelfinavir, and ritonavir when combined with other drugs, based on patient age and treatment group.

Afección:Fase:
Infecciones por el VIH
Fase 1

Detalles del estudio

The Master RAD Protocol is based on the concept that optimal suppression of viral load in vivo will be achieved in patients with rapidly progressing or advanced HIV disease (RAD) using antiretroviral combinations inhibiting viral replication at distinct sites of action. Antiretroviral combinations are chosen with the hypothesis that simultaneous change to as many new agents as possible is necessary to maximally reduce plasma viral load.In this open-label, multicenter study patients are randomized into 1 of 4 groups based on prior antiretroviral experience. Each regimen consists of 4 drugs that include a combination of nucleoside reverse transcriptase inhibitors (stavudine, lamivudine, zidovudine, didanosine, zalcitabine) plus nevirapine (NVP), nelfinavir (NFV), or ritonavir (RTV). Patients must be naive to at least 2 of the 4 drugs in the regimen and at least 1 of the novel drugs must be NVP, NFV, or RTV. Prior to randomization to a NFV- or RTV-containing regimen, patients are stratified by HIV RNA (greater than or equal to 50,000 or less than 50,000) and must able to receive 2 or more novel drugs.

Criterios de exclusión

    Your child will not be eligible for this study if he or she: Is receiving treatment for a serious bacterial, viral, or opportunistic (HIV-associated) infection within 14 days prior to study entry. Has a history of pancreatitis or peripheral neuropathy. Has cancer requiring chemotherapy. Is allergic to the study medications. Is taking certain medications. Is pregnant.

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

    UCSD Med Ctr / Pediatrics / Clinical Sciences, La Jolla, California, 920930672, United States

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

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

    Cedars Sinai / UCLA Med Ctr, Los Angeles, California, 900481804, 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

Colorado

    Children's Hosp of Denver, Denver, Colorado, 802181088, United States

Connecticut

    Connecticut Children's Med Ctr, Farmington, Connecticut, 060303805, United States

    Yale Univ Med School, New Haven, Connecticut, 06504, 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 Health Science Ctr / Pediatrics, Jacksonville, Florida, 32209, United States

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

Georgia

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

    Med College of Georgia, Augusta, Georgia, 30912, United States

    The Med Ctr Inc, Columbus, Georgia, 31901, United States

Illinois

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

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

    Univ of Illinois College of Medicine / Pediatrics, Chicago, Illinois, 60612, United States

Louisiana

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

    Boston City Hosp / Pediatrics, Boston, Massachusetts, 02118, United States

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

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

Mississippi

    Univ of Mississippi Med Ctr, Jackson, Mississippi, 39213, United States

New Jersey

    UMDNJ - Robert Wood Johnson Med School / Pediatrics, New Brunswick, New Jersey, 089030019, United States

    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

    Children's Hosp at Albany Med Ctr, Albany, New York, 12208, United States

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

    SUNY - Brooklyn, Brooklyn, New York, 11203, 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

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

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

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

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

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

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

    Univ of Rochester Med Ctr, Rochester, New York, 146420001, 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

    Univ of North Carolina at Chapel Hill / Duke Univ Med Ctr, Durham, North Carolina, 27710, United States

Ohio

    Columbus Children's Hosp, Columbus, Ohio, 432052696, United States

Pennsylvania

    Children's Hosp of Philadelphia, Philadelphia, Pennsylvania, 191044318, United States

    Saint Christopher's Hosp for Children, Philadelphia, Pennsylvania, 191341095, 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

    Vanderbilt Univ Med Ctr, Nashville, Tennessee, 372322581, United States

Texas

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

    Texas Children's Hosp / Baylor Univ, Houston, Texas, 77030, 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

Volver arriba