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A Study to Evaluate the Use of Memantine In Combination with Anti-HIV Drugs to Treat AIDS Dementia Complex (ADC) Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on A Study to Evaluate the Use of Memantine In Combination with Anti-HIV Drugs to Treat AIDS Dementia Complex (ADC) conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. A Study to Evaluate the Use of Memantine In Combination with Anti-HIV Drugs to Treat AIDS Dementia Complex (ADC) Clinical research trials and A Study to Evaluate the Use of Memantine In Combination with Anti-HIV Drugs to Treat AIDS Dementia Complex (ADC) healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as A Study to Evaluate the Use of Memantine In Combination with Anti-HIV Drugs to Treat AIDS Dementia Complex (ADC). A Study to Evaluate the Use of Memantine In Combination with Anti-HIV Drugs to Treat AIDS Dementia Complex (ADC) Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a A Study to Evaluate the Use of Memantine In Combination with Anti-HIV Drugs to Treat AIDS Dementia Complex (ADC) clinical trial. Human subjects often receive the most effective healthcare possible for their A Study to Evaluate the Use of Memantine In Combination with Anti-HIV Drugs to Treat AIDS Dementia Complex (ADC) condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Study to Evaluate the Use of Memantine In Combination with Anti-HIV Drugs to Treat AIDS Dementia Complex (ADC)  A Study to Evaluate the Use of Memantine In Combination with Anti-HIV Drugs to Treat AIDS Dementia Complex (ADC)
A Study to Evaluate the Use of Memantine In Combination with Anti-HIV Drugs to Treat AIDS Dementia Complex (ADC)
For Condition: AIDS Dementia Complex,HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 120
Location and Contact Information:
Overall Study Official:
BradfordNavia, Study Chair,
Boston Med Ctr
Boston, Massachusetts, 02118
United States
Case Western Reserve Univ
Cleveland, Ohio, 44106
United States
Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ
New York City, New York, 10021
United States
Univ of Kentucky Lexington
Cincinnati, Ohio, 45267
United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
United States
San Francisco Gen Hosp
San Francisco, California, 941102859
United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Beth Israel Med Ctr
New York City, New York, 10003
United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
United States
Univ of Texas Galveston
Galveston, Texas, 775550435
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, 46202
United States
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, 02215
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
United States
Univ of Hawaii
Honolulu, Hawaii, 96816
United States
Queens Med Ctr
Honolulu, Hawaii, 96816
United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
United States
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, 941102859
United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
United States
Yale Univ / New Haven
New Haven, Connecticut, 065102483
United States
UCLA CARE Ctr
Los Angeles, California, 90095
United States
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
Harbor UCLA Med Ctr
Torrance, California, 90502
United States
Univ of Nebraska Med Ctr
Omaha, Nebraska, 681985130
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Univ of Washington
Seattle, Washington, 98104
United States
Additional Information:
Study ID Numbers: ACTG 301;
Study Start Date:
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000867
Other Hiv Infections Studies:
1. A Trial of Alternating 2',3'-Dideoxycytidine and Zidovudine in the Treatment of Patients With Advanced HIV Disease
2. Safety and Effectiveness of the Oral HIV Entry Inhibitor SCH 417690 in HIV Infected Patients
3. HIV Candidate Vaccine, ALVAC-HIV-1, Administration in HIV-Negative Adults
4. A Comparative Trial of Valacyclovir Hydrochloride ( 256U87 ) and Acyclovir for the Suppression of Anogenital Herpes Infections in HIV-Infected Patients
5. A Pilot, Open-Label, Phase II, Randomized Study to Determine the Effects of Viracept on the Outcome of Cutaneous and Mucosal KS in AIDS Patients with CD4 <= 500 cells/mm3
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A Study to Evaluate the Use of Memantine In Combination with Anti-HIV Drugs to Treat AIDS Dementia Complex (ADC)
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