A Phase III, Randomized, Double-Blind, Multicentre Study to Evaluate the Safety and Efficacy of 1592U89 in Patients With AIDS Dementia Complex

June 23, 2005 updated by: Glaxo Wellcome
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • Univ of Manitoba / Faculty of Medicine
    • Ontario
      • Toronto, Ontario, Canada
        • Wellesley Hosp
  • United States
    • California
      • San Diego, California, United States, 92103
        • HIV Neurobehavioral Research Ctr
      • San Francisco, California, United States, 94110
        • San Francisco Gen Hosp
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Univ School of Medicine
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington Univ Med Ctr
    • New York
      • New York, New York, United States, 10029
        • Mount Sinai Med Ctr
      • New York, New York, United States, 10032
        • Columbia Univ / Sergievsky Ctr
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Univ of North Carolina School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

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.

Exclusion Criteria

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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Glaxo Wellcome

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

November 1, 1998

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 238B
  • CNAB 3001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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