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Ensayos clínicos

Ensayos clínicos

A Study to Compare the Use of Fluconazole as Continuous Therapy Versus Periodic Therapy in HIV-Positive Patients with Recurrent Thrush

Patrocinador(es) del estudio: National Institute of Allergy and Infectious Diseases (NIAID)
Números de identificación: NCT00000951, ACTG 323
  • Concluido

Propósito del estudio

To compare the effects of management strategies using episodic fluconazole therapy versus continuous fluconazole prophylaxis for oropharyngeal candidiasis on the time to development of clinically significant fluconazole-refractory infections.

Afección:Fase:
Candidiasis Oral
Infecciones por el VIH
Fase 4

Detalles del estudio

This study will evaluate two different management strategies for patients with advanced HIV infection who are at risk for recurrent and fluconazole-refractory oropharyngeal candidiasis. The treatment duration will be at least 24 months in order to evaluate the long-term effects of the treatment strategies on the development of fluconazole-refractory thrush. In addition to investigating antifungal treatment as it relates to fluconazole-refractory infections, the study will evaluate host factors and organism-related factors in order to increase our understanding of the pathogenesis of oropharyngeal candidiasis and fluconazole-refractory infections.Prior to randomization to a long-term management strategy using fluconazole, patients are stratified into one of three groups according to their baseline CD4+ count (cells/mm3): 0-49, 50-100, and 101-150. Patients without oropharyngeal candidiasis (no thrush present) at enrollment and those patients who respond (no thrush present) to the initial acute therapy for an active infection are randomized 1:1 to one of two management strategies for fluconazole: Arm A (episodic therapy) or Arm B (chronic suppressive therapy with continuous fluconazole). Patients are then followed for a duration of 24 months after enrollment of the last subject. Patients with active oropharyngeal candidiasis at time of enrollment will be treated with fluconazole for up to 2 weeks and patients who respond (no thrush present) are then randomized to a long-term management strategy. Those who do not respond (refractory disease) to the acute treatment are permanently discontinued from the study. Women in both groups will have the option of being treated for vulvovaginal candidiasis either through or outside the study.

Criterios de exclusión

    You will not be eligible for this study if you: Have an allergy to azoles. Have had 3 episodes or more of thrush within 12 weeks of study entry. Have a history of esophageal candidiasis. Have a history of fluconazole-resistant infection. Have an active opportunistic infection requiring treatment within 14 days before study entry. Have a fungal infection requiring certain medications. Have a severe liver disease (e.g., cirrhosis). Are unable to tolerate oral medications. Take certain medications. Are pregnant or breast-feeding.

Centros de estudio/contactos

California

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

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

Colorado

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

District of Columbia

    Institute for Clinical Research, Washington, District of Columbia, 20422, United States

    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

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

    Louis A Weiss Memorial Hosp, Chicago, Illinois, 60640, 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

Iowa

    Univ of Iowa Hosp and Clinic, Iowa City, Iowa, 52242, United States

Maryland

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

    State of MD Div of Corrections / Johns Hopkins Univ Hosp, Baltimore, Maryland, 212052196, 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

    Hennepin County Med Clinic, Minneapolis, Minnesota, 55415, United States

    St Paul Ramsey Med Ctr, St Paul, Minnesota, 55101, United States

Missouri

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

Nebraska

    Univ of Nebraska Med Ctr, Omaha, Nebraska, 681985130, United States

New York

    Albert Einstein College of Medicine, Bronx, New York, 10461, United States

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

    St Vincent's Hosp / 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

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

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

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

    Saint Clare's Hosp and Health Ctr, New York, New York, 10019, United States

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

    St Mary's Hosp (Univ of Rochester/Infectious Diseases), 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

    Univ of Kentucky Lexington, Cincinnati, Ohio, 45267, United States

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

    MetroHealth Med Ctr, Cleveland, Ohio, 441091998, United States

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

Pennsylvania

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

    Philadelphia Veterans Administration Med Ctr, Philadelphia, Pennsylvania, 19104, United States

South Carolina

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

Tennessee

    Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr, Knoxville, Tennessee, 37920, United States

Texas

    Univ of Texas Galveston, Galveston, Texas, 775550435, 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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