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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00002288
Enrollment
Unknown
Registered
2001-08-31
Start date
Unknown
Completion date
Unknown
Last updated
2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

Neuropsychological Tests, AIDS-Related Complex, Zidovudine

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.

Interventions

DRUGZidovudine

Sponsors

Glaxo Wellcome
Lead SponsorINDUSTRY

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026