AIDS Dementia ComplexPhase 2NCT00000867
A Study to Evaluate the Use of Memantine In Combination With Anti-HIV Drugs to Treat AIDS Dementia Complex (ADC)
A Phase 2 study testing Memantine in people with AIDS Dementia Complex and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 19 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AIDS Dementia Complex, HIV Infections
- What is being tested?
- Memantine
- How many people
- 120 participants
- Where
- 19 sitesUnited States
- Study dates
- Dec 1996to Jul 2001
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Bmc Actg Crs
Boston, Massachusetts, 02118
Beth Israel Deaconess - East Campus A0102 CRS
Boston, Massachusetts, 02215
SUNY - Buffalo, Erie County Medical Ctr.
Buffalo, New York, 14215
Northwestern University CRS
Chicago, Illinois, 60611
Cook County Hosp. CORE Ctr.
Chicago, Illinois, 60612
Queens Med. Ctr.
Honolulu, Hawaii, 96816
Univ. of Hawaii at Manoa, Leahi Hosp.
Honolulu, Hawaii, 96816
The Univ. of Kentucky, Lexington A2405 CRS
Lexington, Kentucky, 40536-0226
UCLA CARE Center CRS
Los Angeles, California, 90095
Univ. of Miami AIDS CRS
Miami, Florida, 33136
Beth Israel Med. Ctr. (Mt. Sinai)
New York, New York, 10003
Mt. Sinai Med. Ctr. (N.Y.) A1801 CRS
New York, New York, 10029
Mt. Sinai Med. Ctr. A0404 CRS
New York, New York, 10029
Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.
Omaha, Nebraska, 68198
Hosp. of the Univ. of Pennsylvania CRS
Philadelphia, Pennsylvania, 19104
Univ. of Rochester ACTG CRS
Rochester, New York, 14642
Ucsf Aids Crs
San Francisco, California, 94110
University of Washington AIDS CRS
Seattle, Washington, 98104
Washington U CRS
St Louis, Missouri, 63110
About this study
Official title: A Phase II, Randomized, Double Blind, Placebo-Controlled Trial of Memantine for AIDS Dementia Complex (ADC) as Concurrent Treatment With Antiretroviral Therapy
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.
Read the 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.]
- Conditions
- AIDS Dementia Complex, HIV Infections
- Being tested
- Memantine
- Keywords
- Drug Therapy, Combination, Administration, Oral, AIDS Dementia Complex, Zidovudine, Anti-HIV Agents, Memantine
- Medical subject headings
- AIDS Dementia Complex, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MemantineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study startDec 1996
- Study completionJul 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AIDS Dementia ComplexStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Enrolment
- 120 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Bradford Navia, Study chairRichard Price, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000867
- Sponsor's protocol ID
- ACTG 301
- Other IDs
- DAIDS-ES ID 10687
- Status last verified
- Jun 2013
- First submitted
- 2 Nov 1999
- Last updated
- 10 Jun 2013
- Results posted
- No
Publications
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 (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. doi: 10.1097/QAD.0b013e32813384e8.
PubMed 17721095Zhao 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-Feb;11(1):59-67. doi: 10.1310/hct1101-59.
PubMed 20400412
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Double Blind, Placebo-Controlled Trial of Memantine for AIDS Dementia Complex (ADC) as Concurrent Treatment With Antiretroviral Therapy
- ClinicalTrials.gov ID
- NCT00000867
- Acronym / sponsor ID
- ACTG 301
- Conditions
- AIDS Dementia Complex, HIV Infections
- Keywords
- Drug Therapy, Combination, Administration, Oral, AIDS Dementia Complex, Zidovudine, Anti-HIV Agents, Memantine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Dec 1996
- Study completion
- Jul 2001 (actual)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Memantine | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2013.
- BackgroundLetendre 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.
- Results publication: PubMed 17721095Schifitto 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. doi: 10.1097/QAD.0b013e32813384e8.
- Results publication: PubMed 20400412Zhao 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-Feb;11(1):59-67. doi: 10.1310/hct1101-59.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bradford Navia study chair
Richard Price study chair
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Memantine in people with AIDS Dementia Complex and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 19 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000867, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2013.