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Ensayos clínicos

Ensayos clínicos

A Study to Evaluate the Use of Memantine In Combination with Anti-HIV Drugs to Treat AIDS Dementia Complex (ADC)

Patrocinador(es) del estudio: National Institute of Allergy and Infectious Diseases (NIAID)
Números de identificación: NCT00000867, ACTG 301
  • Concluido

Propósito del estudio

The purpose of this study is to determine the safety and effectiveness of memantine, an experimental drug, in improving AIDS dementia complex (ADC). The symptoms of ADC can be improved with zidovudine (ZDV). However, ZDV therapy has been associated with significant toxicities, and the effectiveness of ZDV seems to decrease during the second and third years of therapy. The effectiveness of other antiretroviral drugs as treatment for ADC is not known, so it is important to explore alternative therapies.

Afección:Fase:
AIDS Dementia Complex
Infecciones por el VIH
Fase 2

Detalles del estudio

The signs and symptoms of the AIDS Dementia Complex can be alleviated by zidovudine (ZDV). However, ZDV therapy has been associated with significant toxicities, particularly bone marrow suppression. The efficacy of ZDV appears to decrease during the second and third years of therapy. It is not known whether this reflects cumulative toxicity. In addition, the efficacy of other antiretroviral agents remains uncertain. Hence, adjunctive therapy for cognitive and motor symptoms of AIDS is important.

Patients will be randomized to one of the following 2 arms: Arm 1 receives memantine plus concurrent antiretroviral therapy; Arm 2 receives placebo plus concurrent antiretroviral therapy. The initial dose of memantine is increased each week for the next 3 weeks, unless a maximum tolerated dose is reached. Following a 16-week evaluation period there is a 4-week washout prior to re-assessment. After the washout period, all patients, including those formerly randomized to the placebo arm, are given the opportunity to receive an open-label, 12-week administration of memantine. [AS PER AMENDMENT 4/6/99: The open-label phase is extended by 48 weeks to a total of 60 weeks of therapy. Patients who did not receive the initial 12 weeks of open-label treatment are eligible still for the 48-week open-label treatment phase.]The signs and symptoms of the AIDS Dementia Complex can be alleviated by zidovudine (ZDV). However, ZDV therapy has been associated with significant toxicities, particularly bone marrow suppression. The efficacy of ZDV appears to decrease during the second and third years of therapy. It is not known whether this reflects cumulative toxicity. In addition, the efficacy of other antiretroviral agents remains uncertain. Hence, adjunctive therapy for cognitive and motor symptoms of AIDS is important.

Patients will be randomized to one of the following 2 arms: Arm 1 receives memantine plus concurrent antiretroviral therapy; Arm 2 receives placebo plus concurrent antiretroviral therapy. The initial dose of memantine is increased each week for the next 3 weeks, unless a maximum tolerated dose is reached. Following a 16-week evaluation period there is a 4-week washout prior to re-assessment. After the washout period, all patients, including those formerly randomized to the placebo arm, are given the opportunity to receive an open-label, 12-week administration of memantine. [AS PER AMENDMENT 4/6/99: The open-label phase is extended by 48 weeks to a total of 60 weeks of therapy. Patients who did not receive the initial 12 weeks of open-label treatment are eligible still for the 48-week open-label treatment phase.]

Criterios de inclusión

    You may be eligible for this study if you: Are HIV positive. Have been diagnosed with AIDS dementia complex (ADC). Have an estimated IQ of at least 70 (before the onset of ADC) or the ability to read at a 6th grade level. Have impaired mental skills. Are age18 or older.

Criterios de exclusión

    You will not be eligible for this study if you: Have a history of a neurologic disease unrelated to HIV infection. Have a history of chronic seizures or head injuries. Have a history of central nervous system infections. Have certain cancers. Have any psychiatric illness. Have an active AIDS-defining opportunistic infection. Are pregnant or breast-feeding.

Centros de estudio/contactos

California

    UCLA CARE Center CRS, Los Angeles, California, 90095, United States

    Ucsf Aids Crs, San Francisco, California, 94110, United States

Florida

    Univ. of Miami AIDS CRS, Miami, Florida, 33136, United States

Hawaii

    Queens Med. Ctr., Honolulu, Hawaii, 96816, United States

    Univ. of Hawaii at Manoa, Leahi Hosp., Honolulu, Hawaii, 96816, United States

Illinois

    Northwestern University CRS, Chicago, Illinois, 60611, United States

    Cook County Hosp. CORE Ctr., Chicago, Illinois, 60612, United States

Kentucky

    The Univ. of Kentucky, Lexington A2405 CRS, Lexington, Kentucky, 40536-0226, United States

Massachusetts

    Beth Israel Deaconess - East Campus A0102 CRS, Boston, Massachusetts, 02215, United States

    Bmc Actg Crs, Boston, Massachusetts, 02118, United States

Missouri

    Washington U CRS, St. Louis, Missouri, 63110, United States

Nebraska

    Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr., Omaha, Nebraska, 68198, United States

New York

    SUNY - Buffalo, Erie County Medical Ctr., Buffalo, New York, 14215, United States

    Mt. Sinai Med. Ctr. (N.Y.) A1801 CRS, New York, New York, 10029, United States

    Beth Israel Med. Ctr. (Mt. Sinai), New York, New York, 10003, United States

    Mt. Sinai Med. Ctr. A0404 CRS, New York, New York, 10029, United States

    Univ. of Rochester ACTG CRS, Rochester, New York, 14642, United States

Pennsylvania

    Hosp. of the Univ. of Pennsylvania CRS, Philadelphia, Pennsylvania, 19104, United States

Washington

    University of Washington AIDS CRS, Seattle, Washington, 98104, United States

Actualizado: 13 de octubre del 2004

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