Clinical trial NCT00002288: The Safety and Effectiveness of Retrovir in HIV-Infected Patients Who Have Problems Related to the Nervous System
Official title: Safety and Efficacy of Retrovir in HIV Infected Patients Having Neuropsychological Impairments
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: Neuropsychological Tests
AIDS-Related Complex
Zidovudine
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Research Triangle Park
country: United States
facility: Glaxo Wellcome Inc
state: North Carolina
Study officials:
References: