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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000867
• Other study ID #: ACTG 301
• Secondary ID: DAIDS-ES ID 1068
• Status: Completed
• Phase: Phase 2
• First received: November 2, 1999
• Last updated: June 7, 2013
• Start date: December 1996
• Est. completion date: July 2001

Study information

• Verified date: June 2013
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.]

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• AIDS Dementia Complex
• Dementia
• HIV Infections

Intervention

Drug:
• Memantine

Locations

Country	Name	City	State
United States	Beth Israel Deaconess - East Campus A0102 CRS	Boston	Massachusetts
United States	Bmc Actg Crs	Boston	Massachusetts
United States	SUNY - Buffalo, Erie County Medical Ctr.	Buffalo	New York
United States	Cook County Hosp. CORE Ctr.	Chicago	Illinois
United States	Northwestern University CRS	Chicago	Illinois
United States	Queens Med. Ctr.	Honolulu	Hawaii
United States	Univ. of Hawaii at Manoa, Leahi Hosp.	Honolulu	Hawaii
United States	The Univ. of Kentucky, Lexington A2405 CRS	Lexington	Kentucky
United States	UCLA CARE Center CRS	Los Angeles	California
United States	Univ. of Miami AIDS CRS	Miami	Florida
United States	Beth Israel Med. Ctr. (Mt. Sinai)	New York	New York
United States	Mt. Sinai Med. Ctr. (N.Y.) A1801 CRS	New York	New York
United States	Mt. Sinai Med. Ctr. A0404 CRS	New York	New York
United States	Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.	Omaha	Nebraska
United States	Hosp. of the Univ. of Pennsylvania CRS	Philadelphia	Pennsylvania
United States	Univ. of Rochester ACTG CRS	Rochester	New York
United States	Ucsf Aids Crs	San Francisco	California
United States	University of Washington AIDS CRS	Seattle	Washington
United States	Washington U CRS	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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.

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 — View 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 — View Citation

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