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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002288
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
NIH AIDS Clinical Trials Information Service
  Purpose
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.

Condition Intervention
HIV Infections Drug: Zidovudine

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Safety and Efficacy of Retrovir in HIV Infected Patients Having Neuropsychological Impairments

Resource links provided by NLM:


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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002288


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

ClinicalTrials.gov Identifier: NCT00002288     History of Changes
Other Study ID Numbers: 014K
23
First Submitted: November 2, 1999
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
Last Verified: February 1995

Keywords provided by NIH AIDS Clinical Trials Information Service:
Neuropsychological Tests
AIDS-Related Complex
Zidovudine

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Zidovudine
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents