Completed

Retrovir Therapy for HIV Patients with Neuropsychological Impairments

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What is being tested

Zidovudine

Drug
Who is being recruted

Blood-Borne Infections+13

+ Urogenital Diseases

+ Genital Diseases

From 18 to 50 Years
+15 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
See protocol details

Summary

Principal SponsorGlaxo Wellcome
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

This study focuses on evaluating the effectiveness of a drug called Retrovir, also known as AZT, in treating HIV-positive individuals who experience issues with neuropsychological functioning. The goal is to help those who, despite being HIV-positive, show minimal other symptoms but have impairments in cognitive functions. The study aims to address the current need for effective treatments that can improve neuropsychological health in HIV-positive individuals, contributing to overall better care and quality of life. During the study, participants receive Retrovir (AZT) therapy. The study measures the safety of this treatment, along with its impact on the virus and the immune system. The primary objective is to determine if Retrovir can improve neuropsychological functioning in HIV-positive individuals with minimal other symptoms. The effects of the drug are monitored to ensure safety and assess its potential benefits for this specific population.

NCT00002288
Principal SponsorGlaxo Wellcome
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsAIDS-Related ComplexHIV Infections

Criteria

7 inclusion criteria required to participate
Ability to give informed consent or a person with durable power of attorney who can give informed consent
Asymptomatic HIV infection
Early AIDS related complex (ARC)
Impaired performance on a defined neuropsychological test battery
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8 exclusion criteria prevent from participating
AIDS or advanced ARC
Antiretroviral agents including zidovudine (AZT)
Blood transfusion within 3 months of study entry
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
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Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Glaxo Wellcome Inc

Research Triangle Park, United StatesOpen Glaxo Wellcome Inc in Google Maps
CompletedOne Study Center