AIDS Dementia ComplexPhase 3NCT00002163
A Phase III, Randomized, Double-Blind, Multicentre Study to Evaluate the Safety and Efficacy of 1592U89 in Patients With AIDS Dementia Complex
A Phase 3 study testing Abacavir sulfate in people with AIDS Dementia Complex and HIV Infections, run by Glaxo Wellcome at 9 sites in 2 countries.
Trial summary
To evaluate the benefit of adding 1592U89 to current antiretroviral therapies for AIDS dementia complex and to assess the safety and tolerance of the treatment regimens. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- AIDS Dementia Complex, HIV Infections
- What is being tested?
- Abacavir sulfate
- How many people
- Not given
- Where
- 9 sitesin 2 countries
- Study dates
- Start not givento not given
- Phase
- Phase 3
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have:
- Documented HIV infection.
- Evidence of HIV - associated dementia.
- Been on stable antiretroviral treatment for a minimum of 6 weeks prior to study entry.
Who cannot join
- Co-existing Condition:
- Patients with any of the following symptoms or conditions are excluded:
- Debilitated as a result of their HIV disease, associated illness or therapies who the investigator determines will not be able to complete the 12 week randomized dosing period.
- Memorial Sloan-Kettering (MSK) score of >= 3 for dementia.
- Confounding neurological diseases which may interfere with interpretation of neurological and neurophysical assessments.
- Malabsorption syndrome or other gastrointestinal dysfunction which renders them unable to take oral medication.
Show all 44Show fewer
- Chronic diseases such as diabetes, congestive heart failure, cardiomyopathy, other cardiac dysfunctions, etc., which in the investigator's opinion would compromise the safety of the patient.
- Symptomatic AIDS-defining opportunistic infection not responsive to therapy.
- Concurrent Medication:
- Excluded:
- Treatment with cytotoxic chemotherapeutic agents within the first 12 weeks of the study.
- Treatment with nerve growth factor within the first 12 weeks of study.
- The use of narcotic analgesics, sedatives, benzodiazepines, antidepressants, anti-psychotic agents and other psychoactive drugs which would interfere with the assessment of the neurological and neurophysical status of the patient.
- Use of stavudine (d4T) during the first 12 weeks of the study.
- Immunomodulating agents (except GM/G-CSF or epoietin).
- Psychoactive drugs (at the investigator's discretion).
- Concurrent Treatment:
- Excluded:
- Treatment with radiation therapy within the first 12 weeks of the study.
- NOTE:
- With the exception of local treatment for Kaposi's sarcoma.
- Patients with any of the following prior conditions are excluded:
- Previous neurological disease unrelated to HIV infection.
- History of clinically apparent hepatitis within the last 6 months.
- History of clinically apparent pancreatitis in the last 6 months.
- Prior Medication:
- Excluded:
- Treatment with cytotoxic chemotherapeutic agents within 1 month of entry.
- Participation in investigational antiretroviral trials within the past 3 months.
- HIV vaccine within the past 3 months.
- Treatment with immunomodulating agents such as systemic corticosteroids, interleukins, thalidomide, anticytokine agents, anti-oxidants or interferons within 1 month of study entry.
- Nerve growth factor.
- Prior Treatment:
- Excluded:
- Treatment with radiation therapy within 1 month of entry.
- NOTE:
- With the exception of local treatment for Kaposi's sarcoma.
- Risk Behavior:
- Excluded:
- Current alcohol or illicit drug use which may interfere with the patient's ability to comply with the study protocol.
- Required:
- Stable antiretroviral treatment that has been ongoing for a minimum of 6 weeks prior to study entry, may or may not include ZDV.
- Required:
- Stable antiretroviral treatment for a minimum of 6 weeks prior to study entry.
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States7 sites
Johns Hopkins Univ School of Medicine
Baltimore, Maryland, 21287
Univ of North Carolina School of Medicine
Chapel Hill, North Carolina, 27599
Mount Sinai Med Ctr
New York, New York, 10029
Columbia Univ / Sergievsky Ctr
New York, New York, 10032
HIV Neurobehavioral Research Ctr
San Diego, California, 92103
San Francisco Gen Hosp
San Francisco, California, 94110
Washington Univ Med Ctr
St Louis, Missouri, 63110
Canada2 sites
Wellesley Hosp
Toronto, Ontario
Univ of Manitoba / Faculty of Medicine
Winnipeg, Manitoba
About this study
To evaluate the benefit of adding 1592U89 to current antiretroviral therapies for AIDS dementia complex and to assess the safety and tolerance of the treatment regimens.
Read the detailed description
Patients must be on stable antiretroviral treatment for at least 6 weeks prior to study entry and will then be stratified depending on whether their regimen contains zidovudine (ZDV). Each stratum will be randomized separately to receive 1592U89 or placebo for 12 weeks. For the subsequent 40 weeks, open-label 1592U89 will be offered.
- Conditions
- AIDS Dementia Complex, HIV Infections
- Being tested
- Abacavir sulfate
- Keywords
- Acquired Immunodeficiency Syndrome, AIDS Dementia Complex, Antiviral Agents, abacavir
- Medical subject headings
- AIDS Dementia Complex, HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abacavir sulfateDrug
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)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AIDS Dementia ComplexStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Glaxo Wellcome
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002163
- Sponsor's protocol ID
- 238B
- Other IDs
- CNAB 3001
- Status last verified
- Nov 1998
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Lanier ER, Sturge G, McClernon D, Brown S, Halman M, Sacktor N, McArthur J, Atkinson JH, Clifford D, Price RW, Simpson D, Torres G, Catalan J, Marder K, Power C, Hall C, Romero C, Brew B. HIV-1 reverse transcriptase sequence in plasma and cerebrospinal fluid of patients with AIDS dementia complex treated with Abacavir. AIDS. 2001 Apr 13;15(6):747-51. doi: 10.1097/00002030-200104130-00010.
PubMed 11371689
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Double-Blind, Multicentre Study to Evaluate the Safety and Efficacy of 1592U89 in Patients With AIDS Dementia Complex
- ClinicalTrials.gov ID
- NCT00002163
- Acronym / sponsor ID
- 238B
- Conditions
- AIDS Dementia Complex, HIV Infections
- Keywords
- Acquired Immunodeficiency Syndrome, AIDS Dementia Complex, Antiviral Agents, abacavir
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Glaxo WellcomeIndustry (pharma, biotech, devices)
- 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.
To evaluate the benefit of adding 1592U89 to current antiretroviral therapies for AIDS dementia complex and to assess the safety and tolerance of the treatment regimens.
Detailed description
Patients must be on stable antiretroviral treatment for at least 6 weeks prior to study entry and will then be stratified depending on whether their regimen contains zidovudine (ZDV). Each stratum will be randomized separately to receive 1592U89 or placebo for 12 weeks. For the subsequent 40 weeks, open-label 1592U89 will be offered.
Study design
- Primary purpose
- Treatment
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Documented HIV infection.
- Evidence of HIV - associated dementia.
- Been on stable antiretroviral treatment for a minimum of 6 weeks prior to study entry.
Key exclusion criteria (44 listed)
- Debilitated as a result of their HIV disease, associated illness or therapies who the investigator determines will not be able to complete the 12 week randomized dosing period.
- Memorial Sloan-Kettering (MSK) score of >= 3 for dementia.
- Confounding neurological diseases which may interfere with interpretation of neurological and neurophysical assessments.
- Malabsorption syndrome or other gastrointestinal dysfunction which renders them unable to take oral medication.
- Chronic diseases such as diabetes, congestive heart failure, cardiomyopathy, other cardiac dysfunctions, etc., which in the investigator's opinion would compromise the safety of the patient.
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 |
|---|---|---|
| Abacavir sulfate | 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 24 Jun 2005.
- Background: PubMed 11371689Lanier ER, Sturge G, McClernon D, Brown S, Halman M, Sacktor N, McArthur J, Atkinson JH, Clifford D, Price RW, Simpson D, Torres G, Catalan J, Marder K, Power C, Hall C, Romero C, Brew B. HIV-1 reverse transcriptase sequence in plasma and cerebrospinal fluid of patients with AIDS dementia complex treated with Abacavir. AIDS. 2001 Apr 13;15(6):747-51. doi: 10.1097/00002030-200104130-00010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Abacavir sulfate in people with AIDS Dementia Complex and HIV Infections, run by Glaxo Wellcome at 9 sites in 2 countries.
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 4 inclusion and 44 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 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 NCT00002163, which also lists 1 linked publication.
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 24 Jun 2005.