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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002044
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: February 1995
  Purpose

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.


Condition Intervention
AIDS Dementia Complex
Neuromuscular Diseases
HIV Infections
Drug: Zidovudine

Study Type: Interventional
Study Design: Primary Purpose: Treatment
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

Resource links provided by NLM:


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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  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: NCT00002044

Locations
United States, North Carolina
Glaxo Wellcome Inc
Research Triangle Park, North Carolina, United States, 27709
Sponsors and Collaborators
Glaxo Wellcome
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002044     History of Changes
Other Study ID Numbers: 014D, 14
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:
Pilot Projects
Neuromuscular Diseases
Drug Evaluation
Acquired Immunodeficiency Syndrome
AIDS Dementia Complex
AIDS-Related Complex
Zidovudine

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

ClinicalTrials.gov processed this record on July 23, 2014