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The Safety and Effectiveness of Retrovir in HIV-Infected Patients Who Have Problems Related to the Nervous System

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Zidovudine
Sponsored by
Glaxo Wellcome
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Neuropsychological Tests, AIDS-Related Complex, Zidovudine

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Exclusion Criteria Co-existing Condition: Patients with the following are excluded: Neuropsychological (NP) impairments more severe than described in the Inclusion Criteria. Evidence of nervous system dysfunction being caused by factors other than HIV infection, including history of head trauma, multiple sclerosis, epilepsy, or presence of concurrent central nervous system (CNS) infections or neoplasms, e.g., toxoplasmosis, primary or metastatic CNS lymphoma, progressive multifocal leukoencephalopathy, cryptococcal or other fungal meningitis, and CNS tuberculous infections. Lymphoma or other tumor requiring cytotoxic chemotherapy. Concurrent Medication: Excluded: Other antiretroviral agents. Patients with the following are excluded: AIDS or advanced ARC. Neuropsychological (NP) impairments more severe than described above; i.e., defective performance on NP test battery in 3 or more NP areas on the NP screening battery at 2 standard deviations below the mean. Evidence of nervous system dysfunction being caused by factors other than HIV infection, including history of head trauma, multiple sclerosis, epilepsy, or presence of concurrent central nervous system (CNS) metastatic CNS lymphoma, progressive multifocal leukoencephalopathy, cryptococcal or other fungal meningitis, and CNS tuberculous infections. Prior Medication: Excluded: Antiretroviral agents including zidovudine (AZT). Prior Treatment: Excluded within 3 months of study entry: Blood transfusion. Impaired performance on a defined neuropsychological test battery. Asymptomatic HIV infection. Persistent generalized lymphadenopathy (PGL). Early AIDS related complex (ARC). Seropositive for human immunodeficiency virus (HIV) demonstrated by positive ELISA test and confirmed by Western blot with no or minimal symptomatology or HIV infection. Ability to give informed consent or a person with durable power of attorney who can give informed consent. Willingness to be followed by the originating medical center for 1 year. History of drug or alcohol abuse.

Sites / Locations

  • Glaxo Wellcome Inc

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Glaxo Wellcome
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1. Study Identification

Unique Protocol Identification Number
NCT00002288
Brief Title
The Safety and Effectiveness of Retrovir in HIV-Infected Patients Who Have Problems Related to the Nervous System
Official Title
Safety and Efficacy of Retrovir in HIV Infected Patients Having Neuropsychological Impairments
Study Type
Interventional

2. Study Status

Record Verification Date
February 1995
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 assess the efficacy of Retrovir (AZT) therapy in the treatment of HIV Ab positive persons with impairments in neuropsychological functioning. To assess the safety, virologic, and immunologic effects of AZT therapy in HIV Ab positive persons with neuropsychological impairment but minimal other symptomatology.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Neuropsychological Tests, AIDS-Related Complex, Zidovudine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Zidovudine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Exclusion Criteria Co-existing Condition: Patients with the following are excluded: Neuropsychological (NP) impairments more severe than described in the Inclusion Criteria. Evidence of nervous system dysfunction being caused by factors other than HIV infection, including history of head trauma, multiple sclerosis, epilepsy, or presence of concurrent central nervous system (CNS) infections or neoplasms, e.g., toxoplasmosis, primary or metastatic CNS lymphoma, progressive multifocal leukoencephalopathy, cryptococcal or other fungal meningitis, and CNS tuberculous infections. Lymphoma or other tumor requiring cytotoxic chemotherapy. Concurrent Medication: Excluded: Other antiretroviral agents. Patients with the following are excluded: AIDS or advanced ARC. Neuropsychological (NP) impairments more severe than described above; i.e., defective performance on NP test battery in 3 or more NP areas on the NP screening battery at 2 standard deviations below the mean. Evidence of nervous system dysfunction being caused by factors other than HIV infection, including history of head trauma, multiple sclerosis, epilepsy, or presence of concurrent central nervous system (CNS) metastatic CNS lymphoma, progressive multifocal leukoencephalopathy, cryptococcal or other fungal meningitis, and CNS tuberculous infections. Prior Medication: Excluded: Antiretroviral agents including zidovudine (AZT). Prior Treatment: Excluded within 3 months of study entry: Blood transfusion. Impaired performance on a defined neuropsychological test battery. Asymptomatic HIV infection. Persistent generalized lymphadenopathy (PGL). Early AIDS related complex (ARC). Seropositive for human immunodeficiency virus (HIV) demonstrated by positive ELISA test and confirmed by Western blot with no or minimal symptomatology or HIV infection. Ability to give informed consent or a person with durable power of attorney who can give informed consent. Willingness to be followed by the originating medical center for 1 year. History of drug or alcohol abuse.
Facility Information:
Facility Name
Glaxo Wellcome Inc
City
Research Triangle Park
State/Province
North Carolina
ZIP/Postal Code
27709
Country
United States

12. IPD Sharing Statement

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