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OpenTrials
Completed

NCT Number: NCT00002288

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

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.

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Key information

Conditions

HIV Infections AIDS-Related Complex Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Glaxo Wellcome Inc

Research Triangle Park, North Carolina, 27709, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Zidovudine

Drug

Sponsors and collaborators

Lead sponsor

Glaxo Wellcome

Industry

Registry information

Official study title

Safety and Efficacy of Retrovir in HIV Infected Patients Having Neuropsychological Impairments

Important dates

First posted
Aug 31, 2001
Registry last updated
Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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