search
Back to results

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

Primary Purpose

AIDS Dementia Complex, HIV Infections

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Abacavir sulfate
Sponsored by
Glaxo Wellcome
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for AIDS Dementia Complex focused on measuring Acquired Immunodeficiency Syndrome, AIDS Dementia Complex, Antiviral Agents, abacavir

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • HIV Neurobehavioral Research Ctr
  • San Francisco Gen Hosp
  • Johns Hopkins Univ School of Medicine
  • Washington Univ Med Ctr
  • Mount Sinai Med Ctr
  • Columbia Univ / Sergievsky Ctr
  • Univ of North Carolina School of Medicine
  • Univ of Manitoba / Faculty of Medicine
  • Wellesley Hosp

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Glaxo Wellcome
search

1. Study Identification

Unique Protocol Identification Number
NCT00002163
Brief Title
A Phase III, Randomized, Double-Blind, Multicentre Study to Evaluate the Safety and Efficacy of 1592U89 in Patients With AIDS Dementia Complex
Official Title
A Phase III, Randomized, Double-Blind, Multicentre Study to Evaluate the Safety and Efficacy of 1592U89 in Patients With AIDS Dementia Complex
Study Type
Interventional

2. Study Status

Record Verification Date
November 1998
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Glaxo Wellcome

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
AIDS Dementia Complex, HIV Infections
Keywords
Acquired Immunodeficiency Syndrome, AIDS Dementia Complex, Antiviral Agents, abacavir

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Masking
Double

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Abacavir sulfate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
HIV Neurobehavioral Research Ctr
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
San Francisco Gen Hosp
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
Johns Hopkins Univ School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Washington Univ Med Ctr
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Mount Sinai Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia Univ / Sergievsky Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Univ of North Carolina School of Medicine
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Univ of Manitoba / Faculty of Medicine
City
Winnipeg
State/Province
Manitoba
Country
Canada
Facility Name
Wellesley Hosp
City
Toronto
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
11371689
Citation
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs