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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.

Sponsored by: 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

MedlinePlus related topics:   AIDS    AIDS Medicines    Dementia   

Drug Information available for:   Zidovudine    Memantine    Memantine hydrochloride   

U.S. FDA Resources

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

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

Show 31 study locations  Show 31 Study Locations

Sponsors and Collaborators

Investigators
Study Chair:     Bradford Navia    
Study Chair:     Richard Price    
  More Information


Haga clic aquí para ver información sobre este ensayo clínico en español.  This link exits the ClinicalTrials.gov site
 

Publications of Results:

Other Publications:
Letendre S, Zheng J, Yiannoutsos C, Lopez A, Ellis R, Marquie-Beck J, Zimmerman J, Gendelman H, Navia B, and The ACTG 301 and 700 Study Teams. Chemokines Correlate with Cerebral Metabolites on Magnetic Resonance Spectroscopy: A Substudy of ACTG 301 and 700. CROI 2004. Abstract 29.
 

Study ID Numbers:   ACTG 301
First Received:   November 2, 1999
Last Updated:   August 19, 2008
ClinicalTrials.gov Identifier:   NCT00000867
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

Study placed in the following topic categories:
Excitatory Amino Acids
Sexually Transmitted Diseases, Viral
AIDS Dementia Complex
Acquired Immunodeficiency Syndrome
Zidovudine
Central Nervous System Diseases
Brain Diseases
Immunologic Deficiency Syndromes
Cognition Disorders
Virus Diseases
Dopamine
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
HIV Infections
Sexually Transmitted Diseases
Memantine
Dementia
Retroviridae Infections
Delirium

Additional relevant MeSH terms:
RNA Virus Infections
Neurotransmitter Agents
Slow Virus Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Nervous System Diseases
Physiological Effects of Drugs
Antiparkinson Agents
Excitatory Amino Acid Agents
Infection
Pharmacologic Actions
Therapeutic Uses
Lentivirus Infections
Dopamine Agents
Central Nervous System Agents
Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on December 03, 2008




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