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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002288
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: February 1995

November 2, 1999
June 23, 2005
Not Provided
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00002288 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The Safety and Effectiveness of Retrovir in HIV-Infected Patients Who Have Problems Related to the Nervous System
Safety and Efficacy of Retrovir in HIV Infected Patients Having Neuropsychological Impairments

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.

Not Provided
Interventional
Not Provided
Primary Purpose: Treatment
HIV Infections
Drug: Zidovudine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
Not Provided
Not Provided

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.

Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002288
014K, 23
Not Provided
Not Provided
Glaxo Wellcome
Not Provided
Not Provided
NIH AIDS Clinical Trials Information Service
February 1995

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP