- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00000867
A Study to Evaluate the Use of Memantine In Combination With Anti-HIV Drugs to Treat AIDS Dementia Complex (ADC)
A Phase II, Randomized, Double Blind, Placebo-Controlled Trial of Memantine for AIDS Dementia Complex (ADC) as Concurrent Treatment With Antiretroviral Therapy
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.]
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90095
- UCLA CARE Center CRS
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San Francisco, California, United States, 94110
- Ucsf Aids Crs
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Florida
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Miami, Florida, United States, 33136
- Univ. of Miami AIDS CRS
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Hawaii
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Honolulu, Hawaii, United States, 96816
- Univ. of Hawaii at Manoa, Leahi Hosp.
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Honolulu, Hawaii, United States, 96816
- Queens Med. Ctr.
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Illinois
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Chicago, Illinois, United States, 60612
- Cook County Hosp. CORE Ctr.
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Chicago, Illinois, United States, 60611
- Northwestern University CRS
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Kentucky
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Lexington, Kentucky, United States, 40536-0226
- The Univ. of Kentucky, Lexington A2405 CRS
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Massachusetts
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Boston, Massachusetts, United States, 02118
- Bmc Actg Crs
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Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess - East Campus A0102 CRS
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Missouri
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St. Louis, Missouri, United States, 63110
- Washington U CRS
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Nebraska
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Omaha, Nebraska, United States, 68198
- Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.
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New York
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Buffalo, New York, United States, 14215
- SUNY - Buffalo, Erie County Medical Ctr.
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New York, New York, United States, 10003
- Beth Israel Med. Ctr. (Mt. Sinai)
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New York, New York, United States, 10029
- Mt. Sinai Med. Ctr. A0404 CRS
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New York, New York, United States, 10029
- Mt. Sinai Med. Ctr. (N.Y.) A1801 CRS
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Rochester, New York, United States, 14642
- Univ. of Rochester ACTG CRS
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Hosp. of the Univ. of Pennsylvania CRS
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Washington
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Seattle, Washington, United States, 98104
- University of Washington AIDS CRS
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Interventional Model: PARALLEL
Collaborators and Investigators
Investigators
- Study Chair: Bradford Navia
- Study Chair: Richard Price
Publications and helpful links
General 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.
- Schifitto G, Navia BA, Yiannoutsos CT, Marra CM, Chang L, Ernst T, Jarvik JG, Miller EN, Singer EJ, Ellis RJ, Kolson DL, Simpson D, Nath A, Berger J, Shriver SL, Millar LL, Colquhoun D, Lenkinski R, Gonzalez RG, Lipton SA; Adult AIDS Clinical Trial Group (ACTG) 301; 700 Teams; HIV MRS Consortium. Memantine and HIV-associated cognitive impairment: a neuropsychological and proton magnetic resonance spectroscopy study. AIDS. 2007 Sep 12;21(14):1877-86. doi: 10.1097/QAD.0b013e32813384e8.
- Zhao Y, Navia BA, Marra CM, Singer EJ, Chang L, Berger J, Ellis RJ, Kolson DL, Simpson D, Miller EN, Lipton SA, Evans SR, Schifitto G; Adult Aids Clinical Trial Group (ACTG) 301 Team. Memantine for AIDS dementia complex: open-label report of ACTG 301. HIV Clin Trials. 2010 Jan-Feb;11(1):59-67. doi: 10.1310/hct1101-59.
Study record dates
Study Major Dates
Study Start
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Neurocognitive Disorders
- HIV Infections
- Dementia
- AIDS Dementia Complex
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Dopamine Agents
- Antiparkinson Agents
- Anti-Dyskinesia Agents
- Memantine
Other Study ID Numbers
- ACTG 301
- DAIDS-ES ID 10687
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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