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) (NIH)

Overall Status

Completed

CT.gov ID

NCT00000867

Collaborator

(none)

120

Enrollment

Locations

Duration (Months)

6.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
AIDS Dementia Complex HIV Infections	Drug: Memantine	Phase 2

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.]

Study Design

Study Type:

Interventional

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

Study Start Date :

Dec 1, 1996

Actual Study Completion Date :

Jul 1, 2001

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	UCLA CARE Center CRS	Los Angeles	California	United States	90095
2	Ucsf Aids Crs	San Francisco	California	United States	94110
3	Univ. of Miami AIDS CRS	Miami	Florida	United States	33136
4	Queens Med. Ctr.	Honolulu	Hawaii	United States	96816
5	Univ. of Hawaii at Manoa, Leahi Hosp.	Honolulu	Hawaii	United States	96816
6	Northwestern University CRS	Chicago	Illinois	United States	60611
7	Cook County Hosp. CORE Ctr.	Chicago	Illinois	United States	60612
8	The Univ. of Kentucky, Lexington A2405 CRS	Lexington	Kentucky	United States	40536-0226
9	Bmc Actg Crs	Boston	Massachusetts	United States	02118
10	Beth Israel Deaconess - East Campus A0102 CRS	Boston	Massachusetts	United States	02215
11	Washington U CRS	St. Louis	Missouri	United States	63110
12	Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.	Omaha	Nebraska	United States	68198
13	SUNY - Buffalo, Erie County Medical Ctr.	Buffalo	New York	United States	14215
14	Beth Israel Med. Ctr. (Mt. Sinai)	New York	New York	United States	10003
15	Mt. Sinai Med. Ctr. (N.Y.) A1801 CRS	New York	New York	United States	10029
16	Mt. Sinai Med. Ctr. A0404 CRS	New York	New York	United States	10029
17	Univ. of Rochester ACTG CRS	Rochester	New York	United States	14642
18	Hosp. of the Univ. of Pennsylvania CRS	Philadelphia	Pennsylvania	United States	19104
19	University of Washington AIDS CRS	Seattle	Washington	United States	98104