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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002163
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: November 1998
  Purpose

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.


Condition Intervention Phase
AIDS Dementia Complex
HIV Infections
Drug: Abacavir sulfate
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Double-Blind, Multicentre Study to Evaluate the Safety and Efficacy of 1592U89 in Patients With AIDS Dementia Complex

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002163

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

Publications:
ClinicalTrials.gov Identifier: NCT00002163     History of Changes
Other Study ID Numbers: 238B, CNAB 3001
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Acquired Immunodeficiency Syndrome
AIDS Dementia Complex
Antiviral Agents
abacavir

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Dementia
AIDS Dementia Complex
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Abacavir
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on October 16, 2014