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.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000867
First received: November 2, 1999
Last updated: June 7, 2013
Last verified: June 2013
  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

Resource links provided by NLM:


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

Estimated Enrollment: 120
Study Start Date: December 1996
Study Completion Date: July 2001
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
UCLA CARE Center CRS
Los Angeles, California, United States, 90095
Ucsf Aids Crs
San Francisco, California, United States, 94110
United States, Florida
Univ. of Miami AIDS CRS
Miami, Florida, United States, 33136
United States, Hawaii
Queens Med. Ctr.
Honolulu, Hawaii, United States, 96816
Univ. of Hawaii at Manoa, Leahi Hosp.
Honolulu, Hawaii, United States, 96816
United States, Illinois
Northwestern University CRS
Chicago, Illinois, United States, 60611
Cook County Hosp. CORE Ctr.
Chicago, Illinois, United States, 60612
United States, Kentucky
The Univ. of Kentucky, Lexington A2405 CRS
Lexington, Kentucky, United States, 40536-0226
United States, Massachusetts
Beth Israel Deaconess - East Campus A0102 CRS
Boston, Massachusetts, United States, 02215
Bmc Actg Crs
Boston, Massachusetts, United States, 02118
United States, Missouri
Washington U CRS
St. Louis, Missouri, United States, 63110
United States, Nebraska
Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.
Omaha, Nebraska, United States, 68198
United States, New York
SUNY - Buffalo, Erie County Medical Ctr.
Buffalo, New York, United States, 14215
Mt. Sinai Med. Ctr. (N.Y.) A1801 CRS
New York, New York, United States, 10029
Beth Israel Med. Ctr. (Mt. Sinai)
New York, New York, United States, 10003
Mt. Sinai Med. Ctr. A0404 CRS
New York, New York, United States, 10029
Univ. of Rochester ACTG CRS
Rochester, New York, United States, 14642
United States, Pennsylvania
Hosp. of the Univ. of Pennsylvania CRS
Philadelphia, Pennsylvania, United States, 19104
United States, Washington
University of Washington AIDS CRS
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Investigators
Study Chair: Bradford Navia
Study Chair: Richard Price
  More Information

Additional Information:
Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
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: June 7, 2013
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 July 20, 2014