Viewing Study NCT00000867



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Last Modification Date: 2024-10-26 @ 9:02 AM
Study NCT ID: NCT00000867
Status: COMPLETED
Last Update Posted: 2013-06-10
First Post: 1999-11-02

Brief Title: A Study to Evaluate the Use of Memantine In Combination With Anti-HIV Drugs to Treat AIDS Dementia Complex ADC
Sponsor: National Institute of Allergy and Infectious Diseases NIAID
Organization: National Institute of Allergy and Infectious Diseases NIAID

Study Overview

Official Title: A Phase II Randomized Double Blind Placebo-Controlled Trial of Memantine for AIDS Dementia Complex ADC as Concurrent Treatment With Antiretroviral Therapy
Status: COMPLETED
Status Verified Date: 2013-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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
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 4699 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 Oversight

Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
Secondary ID Type Domain Link
DAIDS-ES ID 10687 None None None