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A Study to Evaluate the Use of Memantine In Combination With Anti-HIV Drugs to Treat AIDS Dementia Complex (ADC)
This study has been completed.
First Received: November 2, 1999   Last Updated: August 6, 2009   History of Changes
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000867
  Purpose

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.


Condition Intervention Phase
AIDS Dementia Complex
HIV Infections
Drug: Memantine
Phase II

Study Type: Interventional
Study Design: Treatment, Parallel Assignment, Efficacy Study
Official Title: A Phase II, Randomized, Double Blind, Placebo-Controlled Trial of Memantine for AIDS Dementia Complex (ADC) as Concurrent Treatment With Antiretroviral Therapy

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 120
Detailed Description:

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.]

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000867

  Hide Study Locations
Locations
United States, California
Univ of California / San Diego Treatment Ctr
San Diego, California, United States, 921036325
San Francisco Gen Hosp
San Francisco, California, United States, 941102859
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, United States, 941102859
UCLA CARE Ctr
Los Angeles, California, United States, 90095
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, United States, 900331079
Harbor UCLA Med Ctr
Torrance, California, United States, 90502
United States, Colorado
Univ of Colorado Health Sciences Ctr
Denver, Colorado, United States, 80262
United States, Connecticut
Yale Univ / New Haven
New Haven, Connecticut, United States, 065102483
United States, Florida
Univ of Miami School of Medicine
Miami, Florida, United States, 331361013
United States, Hawaii
Queens Med Ctr
Honolulu, Hawaii, United States, 96816
Univ of Hawaii
Honolulu, Hawaii, United States, 96816
United States, Illinois
Northwestern Univ Med School
Chicago, Illinois, United States, 60611
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States, 60612
Cook County Hosp
Chicago, Illinois, United States, 60612
United States, Indiana
Indiana Univ Hosp
Indianapolis, Indiana, United States, 462025250
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, United States, 02215
Boston Med Ctr
Boston, Massachusetts, United States, 02118
United States, Nebraska
Univ of Nebraska Med Ctr
Omaha, Nebraska, United States, 681985130
United States, New York
Beth Israel Med Ctr
New York, New York, United States, 10003
Mount Sinai Med Ctr
New York, New York, United States, 10029
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, United States, 14215
Univ of Rochester Medical Center
Rochester, New York, United States, 14642
Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ
New York, New York, United States, 10021
United States, North Carolina
Univ of North Carolina
Chapel Hill, North Carolina, United States, 275997215
United States, Ohio
Case Western Reserve Univ
Cleveland, Ohio, United States, 44106
Univ of Kentucky Lexington
Cincinnati, Ohio, United States, 45267
United States, Pennsylvania
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Julio Arroyo
West Columbia, South Carolina, United States, 29169
United States, Texas
Univ of Texas Galveston
Galveston, Texas, United States, 775550435
United States, Washington
Univ of Washington
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Investigators
Study Chair: Bradford Navia
Study Chair: Richard Price
  More Information

Additional Information:
Publications:
Study ID Numbers: ACTG 301, DAIDS-ES ID 10687
Study First Received: November 2, 1999
Last Updated: August 6, 2009
ClinicalTrials.gov Identifier: NCT00000867     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Drug Therapy, Combination
Administration, Oral
AIDS Dementia Complex
Zidovudine
Anti-HIV Agents
Memantine

Additional relevant MeSH terms:
Sexually Transmitted Diseases, Viral
Neurotransmitter Agents
AIDS Dementia Complex
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Antiparkinson Agents
Excitatory Amino Acid Agents
Infection
Brain Diseases
Mental Disorders
Therapeutic Uses
Memantine
Dementia
Retroviridae Infections
Excitatory Amino Acid Antagonists
RNA Virus Infections
Immune System Diseases
Acquired Immunodeficiency Syndrome
Nervous System Diseases
Central Nervous System Diseases
Immunologic Deficiency Syndromes
Pharmacologic Actions
Virus Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Dopamine Agents

ClinicalTrials.gov processed this record on November 27, 2009