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Ensayos clínicos

Ensayos clínicos

A Study to Evaluate the Effects of Stopping Maintenance Therapy for Cytomegalovirus (CMV) Retinitis after Effective Anti-HIV Therapy

Patrocinador(es) del estudio: National Institute of Allergy and Infectious Diseases (NIAID)
Números de identificación: NCT00000905, ACTG 379
  • Concluido

Propósito del estudio

To determine whether it is safe to discontinue maintenance therapy in subjects with treated and healed CMV retinitis who have responded to potent antiretroviral therapy. To estimate the time-to-reactivation of CMV retinitis in HIV-infected patients with treated and healed non-immediate sight-threatening CMV retinitis who have discontinued CMV maintenance therapy.

Afección:
Cytomegalovirus Retinitis
Infecciones por el VIH

Detalles del estudio

This study proposes to assess the hypothesis that, in HIV-infected patients with treated and healed CMV retinitis, an increase in CD4+ T-cells after initiation of potent antiretroviral therapy is either directly related to, or a marker of, immunologic protection for CMV retinitis and is associated with a recovery in specific proliferation responses to CMV antigens.In this study, 100 patients [AS PER AMENDMENT 7/2/99: 50 patients] with treated and healed, non-immediate sight-threatening CMV retinitis will discontinue maintenance therapy for suppression of CMV retinitis. Patients are studied in 2 groups. Patients enrolled in Group 1 have CD4+ counts greater than 100 cells/mm3. Group 2 patients have CD4+ counts of 50-100 cells/mm3 and a minimum of a 2 log10 decrease in plasma HIV-1 RNA level or plasma HIV-1 RNA levels below the limit of detection while receiving potent antiretroviral therapy for at least 8 weeks prior to entry [AS PER AMENDMENT 7/2/99: Group 2 has been withdrawn]. An additional 25 patients who meet eligibility requirements but who choose to continue to receive maintenance therapy may also participate. All patients are followed to evaluate the relationship between reactivation or progression of CMV disease and changes in CMV DNA, HIV-1 RNA, and CD4+ cell counts. Patients are seen at Weeks 2, 4, 6 and 8, and every 4 weeks until study closure or for 12 months after the last subject is enrolled. [AS PER AMENDMENT 12/24/98: Patients with confirmed moderate to severe "immune recovery vitritis" should receive a 3-week course of systemic steroids (oral prednisone recommended). Moderate immune recovery vitritis is defined as symptomatic decrease in visual acuity of 2 or more Snellen lines along with, in the absence of active CMV disease, either 2+ or greater vitreous haze as defined by Nussenblatt et al., or cystoid macular edema.] [AS PER AMENDMENT 7/2/99: During the course of the study in patients with confirmed cystoid macular edema and a concomitant reduction in visual activity below 20/40, both attributable to immune recovery vitritis/uveitis only, a 21-day course of oral prednisone is recommended. This initial course of steroids helps to determine whether there is an improvement in vision or a decrease in macular edema. Long-term management of immune recovery vitritis/uveitis may include intraocular injection of steroids. Ophthalmoscopic examinations and laboratory tests are performed as per protocol.]

Criterios de exclusión

    You will not be eligible for this study if you: Have any unstable or severe medical conditions that would keep you from completing the study. Require chemotherapy or radiation therapy. Have a history of certain eye disorders.

Centros de estudio/contactos

California

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

    UCLA CARE Ctr, Los Angeles, California, 90095, 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

Illinois

    Northwestern Univ Med School, Chicago, Illinois, 60611, United States

Indiana

    Indiana Univ Hosp, Indianapolis, Indiana, 462025250, United States

    Division of Inf Diseases/ Indiana Univ Hosp, Indianapolis, Indiana, 46202, United States

Maryland

    Johns Hopkins Hosp, Baltimore, Maryland, 21287, 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

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

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

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

    Chelsea Ctr, New York, New York, 10021, United States

North Carolina

    Univ of North Carolina, Chapel Hill, North Carolina, 275997215, United States

Ohio

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

Pennsylvania

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

South Carolina

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

Texas

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

Actualizado: 13 de octubre del 2004

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