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A Pilot Study To Evaluate the Effect of Retrovir (Zidovudine: AZT) in the Treatment of Human Immunodeficiency Virus (HIV) Associated Dementia and Neuromuscular Diseases

Primary Purpose

AIDS Dementia Complex, Neuromuscular Diseases, 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 AIDS Dementia Complex focused on measuring Pilot Projects, Neuromuscular Diseases, Drug Evaluation, Acquired Immunodeficiency Syndrome, AIDS Dementia Complex, AIDS-Related Complex, Zidovudine

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Co-existing Condition: Patients with the following are excluded: Past or present renal disease. Significant bone marrow suppression. Blood transfusion within the past month. Liver dysfunction. Evidence of an underlying, severe infection. Evidence of an active life-threatening opportunistic infection at study entry. Severe malabsorption (patients with recent significant weight loss must have a serum carotene level of > 75 IU/ml). Evidence of nervous system dysfunction being caused by factors other than HIV infection, particularly by cerebral toxoplasmosis, lymphoma, cryptococcal meningitis, chronic alcohol abuse, lead poisoning, cytomegalovirus (CMV) infection (patients with retinal CMV infection or other evidence of CMV dementia), syphilis, or progressive multifocal leukoencephalopathy. Other known causes of nerve or muscle disease. Hypersensitivity to zidovudine (AZT). Lymphoma or other tumor requiring cytotoxic chemotherapy. Concurrent Treatment: Allowed: Electron beam therapy to an area of less than 100 cm2. Patients with the following are excluded: Past or present renal disease. Significant bone marrow suppression. Blood transfusion within the past month. Liver dysfunction. Evidence of an underlying, severe infection. Evidence of an active life-threatening opportunistic infection at study entry. Severe malabsorption (patients with recent significant weight loss must have a serum carotene level of > 75 IU/ml). Evidence of nervous system dysfunction being caused by factors other than HIV infection, particularly by cerebral toxoplasmosis, lymphoma, cryptococcal meningitis, chronic alcohol abuse, lead poisoning, cytomegalovirus (CMV) infection (patients with retinal CMV infection or other evidence of CMV dementia), syphilis, or progressive multifocal leukoencephalopathy. Other known causes of nerve or muscle disease. Hypersensitivity to zidovudine (AZT). Lymphoma or other tumor requiring cytotoxic chemotherapy. Patients with AIDS (CDC surveillance definition) or AIDS related complex (ARC). All patients must have either: Dementia as defined by a progressive cognitive impairment in the absence of altered consciousness that is thought to be causally related to HIV infection. Patients in this study will fall into the lower 20 percent (or less) of a normal sample of formal neuropsychological testing. OR One of the following neuromuscular diseases thought to be related to HIV infection: Demyelinating polyneuropathy, axonal polyneuropathy, inflammatory myopathy, or unexplained progressive muscle weakness. Capacity to give informed consent or a person with durable power of attorney who can give informed consent. Life expectancy = or > 4 months. Exclusion Criteria Concurrent Medication: Excluded: Cytotoxic chemotherapy. Steroids. Interferon. Immunomodulating agents. Concurrent Treatment: Excluded: Radiation therapy (except electron beam therapy to an area of less than 100 cm2). Prior Medication: Excluded within 4 weeks of study entry: Cytotoxic chemotherapy. Any retroviral drug including but not limited to zidovudine (AZT), ribavirin, HPA 23, AL721, or phosphonoformate. Steroids. Interferon. Immunomodulating agents. An anticipated need for any of these agents within the next 16 weeks. Prior Treatment: Excluded within 1 month of study entry: Radiation therapy (except electron beam therapy to an area of less than 100 cm2). Blood transfusion.

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
NCT00002044
Brief Title
A Pilot Study To Evaluate the Effect of Retrovir (Zidovudine: AZT) in the Treatment of Human Immunodeficiency Virus (HIV) Associated Dementia and Neuromuscular Diseases
Official Title
A Pilot Study To Evaluate the Effect of Retrovir (Zidovudine: AZT) in the Treatment of Human Immunodeficiency Virus (HIV) Associated Dementia and Neuromuscular Diseases
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
The purpose of this pilot study is to evaluate the efficacy of Retrovir (AZT) in the treatment of AIDS-related dementia and various neuromuscular complications. HIV is both a lymphotropic and neurotropic virus which can affect both the central and peripheral nervous systems (CNS, PNS). There is evidence that the CNS and PNS may harbor the virus in a latent state, with the potential for continuous reinfection of other body systems. Therefore, effective therapeutic efforts against HIV infection should provide effective antiviral activity within the nervous system.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
AIDS Dementia Complex, Neuromuscular Diseases, HIV Infections
Keywords
Pilot Projects, Neuromuscular Diseases, Drug Evaluation, Acquired Immunodeficiency Syndrome, AIDS Dementia Complex, 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
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Co-existing Condition: Patients with the following are excluded: Past or present renal disease. Significant bone marrow suppression. Blood transfusion within the past month. Liver dysfunction. Evidence of an underlying, severe infection. Evidence of an active life-threatening opportunistic infection at study entry. Severe malabsorption (patients with recent significant weight loss must have a serum carotene level of > 75 IU/ml). Evidence of nervous system dysfunction being caused by factors other than HIV infection, particularly by cerebral toxoplasmosis, lymphoma, cryptococcal meningitis, chronic alcohol abuse, lead poisoning, cytomegalovirus (CMV) infection (patients with retinal CMV infection or other evidence of CMV dementia), syphilis, or progressive multifocal leukoencephalopathy. Other known causes of nerve or muscle disease. Hypersensitivity to zidovudine (AZT). Lymphoma or other tumor requiring cytotoxic chemotherapy. Concurrent Treatment: Allowed: Electron beam therapy to an area of less than 100 cm2. Patients with the following are excluded: Past or present renal disease. Significant bone marrow suppression. Blood transfusion within the past month. Liver dysfunction. Evidence of an underlying, severe infection. Evidence of an active life-threatening opportunistic infection at study entry. Severe malabsorption (patients with recent significant weight loss must have a serum carotene level of > 75 IU/ml). Evidence of nervous system dysfunction being caused by factors other than HIV infection, particularly by cerebral toxoplasmosis, lymphoma, cryptococcal meningitis, chronic alcohol abuse, lead poisoning, cytomegalovirus (CMV) infection (patients with retinal CMV infection or other evidence of CMV dementia), syphilis, or progressive multifocal leukoencephalopathy. Other known causes of nerve or muscle disease. Hypersensitivity to zidovudine (AZT). Lymphoma or other tumor requiring cytotoxic chemotherapy. Patients with AIDS (CDC surveillance definition) or AIDS related complex (ARC). All patients must have either: Dementia as defined by a progressive cognitive impairment in the absence of altered consciousness that is thought to be causally related to HIV infection. Patients in this study will fall into the lower 20 percent (or less) of a normal sample of formal neuropsychological testing. OR One of the following neuromuscular diseases thought to be related to HIV infection: Demyelinating polyneuropathy, axonal polyneuropathy, inflammatory myopathy, or unexplained progressive muscle weakness. Capacity to give informed consent or a person with durable power of attorney who can give informed consent. Life expectancy = or > 4 months. Exclusion Criteria Concurrent Medication: Excluded: Cytotoxic chemotherapy. Steroids. Interferon. Immunomodulating agents. Concurrent Treatment: Excluded: Radiation therapy (except electron beam therapy to an area of less than 100 cm2). Prior Medication: Excluded within 4 weeks of study entry: Cytotoxic chemotherapy. Any retroviral drug including but not limited to zidovudine (AZT), ribavirin, HPA 23, AL721, or phosphonoformate. Steroids. Interferon. Immunomodulating agents. An anticipated need for any of these agents within the next 16 weeks. Prior Treatment: Excluded within 1 month of study entry: Radiation therapy (except electron beam therapy to an area of less than 100 cm2). Blood transfusion.
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

Learn more about this trial

A Pilot Study To Evaluate the Effect of Retrovir (Zidovudine: AZT) in the Treatment of Human Immunodeficiency Virus (HIV) Associated Dementia and Neuromuscular Diseases

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