A Study to Evaluate the Use of Memantine In Combination With Anti-HIV Drugs to Treat AIDS Dementia Complex (ADC)
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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 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Primary Purpose: Treatment |
| Official Title: | A Phase II, Randomized, Double Blind, Placebo-Controlled Trial of Memantine for AIDS Dementia Complex (ADC) as Concurrent Treatment With Antiretroviral Therapy |
| Estimated Enrollment: | 120 |
| Study Start Date: | December 1996 |
| Study Completion Date: | July 2001 |
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 |
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
Show 31 Study Locations| Study Chair: | Bradford Navia | |
| Study Chair: | Richard Price |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00000867 History of Changes |
| Other Study ID Numbers: | ACTG 301, DAIDS-ES ID 10687 |
| Study First Received: | November 2, 1999 |
| Last Updated: | October 31, 2012 |
| 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:
|
Acquired Immunodeficiency Syndrome HIV Infections AIDS Dementia Complex Dementia Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Memantine Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013