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Ensayos clínicos

Ensayos clínicos

A Study to Compare Different Drugs Used to Prevent Serious Bacterial Infections in HIV-Positive Children

Patrocinador(es) del estudio: National Institute of Allergy and Infectious Diseases (NIAID)
Números de identificación: NCT00000811, ACTG 254
  • Concluido

Propósito del estudio

PRIMARY: To determine whether micronized atovaquone/azithromycin combination is as effective as trimethoprim/sulfamethoxazole (TMP/SMX) for prophylaxis against serious bacterial infections in HIV-infected infants and children. To compare long-term safety and tolerance of these two regimens. For the first 30 patients, to examine the likelihood of pharmacokinetic interaction between atovaquone and azithromycin. SECONDARY: To determine Pneumocystis carinii pneumonia (PCP) breakthrough rates, incidence of other opportunistic infections and survival, and hospitalization rates in this patient population.

Afección:Fase:
Bacterial Infections
Pneumonia, Pneumocystis Carinii
Infecciones por el VIH
Fase 2

Detalles del estudio

Although TMP/SMX remains the drug of choice for PCP prophylaxis, drug sensitivity may limit its use. Atovaquone has demonstrated greater safety than TMP/SMX and thus is suitable as a candidate drug for treatment and prophylaxis of PCP. Azithromycin, with a broad anti-microbial spectrum (including mycoplasma and atypical mycoplasma), is an attractive prophylactic agent for use in children with HIV infection, due to its relative safety and once-daily dosing regimen. Therefore, the combination of atovaquone and azithromycin may offer broader antimicrobial coverage and greater safety than TMP/SMX.Patients are randomized to receive either TMP/SMX or combination micronized atovaquone/azithromycin. Crossover to the alternative regimen may occur if serious toxicity is observed. Patients are monitored for occurrence of serious bacterial infections or PCP breakthrough, and when a serious bacterial infection occurs, patients are crossed over to the alternative regimen. Treatment continues until 2 years after the last patient is enrolled. The first 30 patients will undergo a pharmacokinetic profile. Patients are followed every 4 weeks for the first 4 months, then every 8 weeks thereafter. [AS PER AMENDMENT 05/28/99: This study was closed to infants and children age 19 months and older on 2/15/99; the study is now open to infants age 3 to 18 months (Stage II). Patients who are age 24 months or older at the time of Stage I closure will have end-of-study evaluations and will no longer be followed on protocol. Patients who are less than 24 months of age at the time of Stage I closure will be allowed to continue in the current version of the protocol. Enrollment for children age 3 to 18 months will continue until 50 subjects have been randomized. Because Stage II is an unblinded study, patients who are less than 24 months of age currently enrolled on Version 4.0 will have their study medication regimen unblinded and their atovaquone dose increased.]

Criterios de exclusión

    Children will not be eligible for this study if they: Have an infection that requires treatment. Are allergic to atovaquone, azithromycin, or TMP/SMX. Have serious diarrhea for more than 1 week. 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

    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

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

    UCLA Med Ctr / Pediatric, Los Angeles, California, 900951752, United States

    Children's Hosp of Los Angeles/UCLA Med Ctr, Los Angeles, California, 900276016, United States

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

    Univ of Connecticut / Farmington, Farmington, Connecticut, 06032, United States

    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 Gainesville, Gainesville, Florida, 32610, United States

    Univ of Florida Health Science Ctr / Pediatrics, Jacksonville, Florida, 32209, United States

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

    Palm Beach County Health Dept, Riviera Beach, Florida, 33404, United States

Georgia

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

    Med College of Georgia, Augusta, Georgia, 30912, 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

    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

    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

Michigan

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

Mississippi

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

New Jersey

    Cooper Hosp - Univ Med Ctr / UMDNJ - New Jersey Med Schl, Camden, New Jersey, 08103, United States

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

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

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

New York

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

    Montefiore Med Ctr Adolescent AIDS Program, Bronx, New York, 10467, United States

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

    SUNY - Brooklyn, Brooklyn, New York, 11203, United States

    Children's Hosp Pact Prog / Children's Hosp of Buffalo, Buffalo, New York, 14222, 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

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

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

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

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

    Harlem Hosp Ctr, New York, New York, 10037, 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

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

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

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

    Hermann Hosp / Univ Texas Health Science Ctr, Houston, Texas, 77030, 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

Washington

    Children's Hospital & Medical Center / Seattle ACTU, Seattle, Washington, 981050371, United States

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

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

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

Actualizado: 28 de octubre del 2004

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