Chicago, Illinois 60612

  • HIV Infections

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.


Study summary:

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.]


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.


Study is Available At:


Original ID:

ACTG 301


NCT ID:

NCT00000867


Secondary ID:

DAIDS-ES ID 10687


Study Acronym:


Brief Title:

A Study to Evaluate the Use of Memantine In Combination With Anti-HIV Drugs to Treat AIDS Dementia Complex (ADC)


Official Title:

A Phase II, Randomized, Double Blind, Placebo-Controlled Trial of Memantine for AIDS Dementia Complex (ADC) as Concurrent Treatment With Antiretroviral Therapy


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Institute of Allergy and Infectious Diseases (NIAID)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Efficacy Study, Interven


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

120


Enrollment Type:


Overall Contact Information

Official Name:Bradford Navia
Study Chair

Study Dates

Start Date:December 1996
Completion Date:July 2001
Completion Type:Actual
Verification Date:June 2013
Last Changed Date:June 7, 2013
First Received Date:November 2, 1999

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:Memantine

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Institute of Allergy and Infectious Diseases (NIAID)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation: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.
Reference Type:Results Reference
Citation: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.
PMID:17721095
Reference Type:Results Reference
Citation: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 1;11(1):59-67.
PMID:20400412

Data Source: ClinicalTrials.gov

Date Processed: April 07, 2020

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