NCT00002044

Completed

A Pilot Study To Evaluate the Effect of Retrovir (Zidovudine...

Glaxo Wellcome Source

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Other study identifiers

Sponsor study identifier

014D

Secondary identifiers

14

Study Type

interventional

Reported enrollment (type unavailable)

N/A

Locations

1 country

Sites

1

Timeline

Study Start

Not reported

Date not reported

Primary Completion

Not reported

Date not reported

Study Completion

Not reported

Date not reported

Brief Summary

The purpose of this pilot study is to evaluate the efficacy of Retrovir (AZT) in the treatment of AIDS-related dementia and various neuromuscular complications. HIV is both a lymphotropic and neurotropic virus which can affect both the central and peripheral nervous systems (CNS, PNS). There is evidence that the CNS and PNS may harbor the virus in a latent state, with the potential for continuous reinfection of other body systems. Therefore, effective therapeutic efforts against HIV infection should provide effective antiviral activity within the nervous system.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Reported enrollment (type unavailable): Not reported
Study completion date: Not reported
Date not reported
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
November 2, 1999
Actual (reported)
First Posted
August 31, 2001
Actual (reported)

Last Updated: June 24, 2005
Status Verified: February 1995
Last Update Submitted: June 23, 2005

Conditions

AIDS Dementia Complex HIV Infections Neuromuscular Diseases

Keywords

Pilot ProjectsNeuromuscular DiseasesDrug EvaluationAcquired Immunodeficiency SyndromeAIDS Dementia ComplexAIDS-Related ComplexZidovudine

Interventions

ZidovudineDrug

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Co-existing Condition:
Patients with the following are excluded:

Sponsors & Collaborators

Glaxo Wellcome
Industrylead

Study Sites (1)

Glaxo Wellcome Inc

Research Triangle Park, North Carolina, 27709, United States

MeSH Terms

Conditions

AIDS Dementia ComplexNeuromuscular DiseasesHIV InfectionsAcquired Immunodeficiency SyndromeAIDS-Related Complex

Interventions

Zidovudine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus Infections

Study Design

Study Type: interventional
Phase: not applicable
Purpose: TREATMENT
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1995-02

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00002044
Data provider: ClinicalTrials.gov
Source updated: 2005-06-24
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:35:11 UTC

Locations

NCT00002063

Treatment of AIDS and AIDS Related Complex. Part-1- Treatment of Patients With ARC (AZT Vs. Placebo)

Not ApplicableCompleted

NCT00002286

A Study of Retrovir in the Treatment of Psoriasis in HIV-Positive Patients

Not ApplicableCompleted

NCT00002048

The Efficacy and Safety of Retrovir in Patients Infected With HIV Who Are Asymptomatic (CDC Group II) or Have Persistent Generalized Lymphadenopathy (CDC Group III)

Not ApplicableCompleted

NCT00002047

Retrovir Capsules in the Treatment of HIV-Infected Patients in Renal Failure

Not ApplicableCompleted

NCT00002023

An Oral Dose-Ranging Finding Study in Patients With HIV Disease, CDC Classification Groups IIB, III, and IV-C2

Not ApplicableCompleted

NCT00002285

A Study of Zidovudine and T Lymphocyte Transfer in the Treatment of HIV Type III in Patients With AIDS

Not ApplicableCompleted

Past or present renal disease.

Significant bone marrow suppression.

Blood transfusion within the past month.

Liver dysfunction.

Evidence of an underlying, severe infection.

Evidence of an active life-threatening opportunistic infection at study entry.

Severe malabsorption (patients with recent significant weight loss must have a serum carotene level of \> 75 IU/ml).

Evidence of nervous system dysfunction being caused by factors other than HIV infection, particularly by cerebral toxoplasmosis, lymphoma, cryptococcal meningitis, chronic alcohol abuse, lead poisoning, cytomegalovirus (CMV) infection (patients with retinal CMV infection or other evidence of CMV dementia), syphilis, or progressive multifocal leukoencephalopathy.

Other known causes of nerve or muscle disease.

Hypersensitivity to zidovudine (AZT).

Lymphoma or other tumor requiring cytotoxic chemotherapy.

Concurrent Treatment:

Allowed:

+20 more criteria

You may not qualify if:

Concurrent Medication:
Excluded:
Cytotoxic chemotherapy.
Steroids.
Interferon.
Immunomodulating agents.
Concurrent Treatment:
Excluded:
Radiation therapy (except electron beam therapy to an area of less than 100 cm2).
Prior Medication:
Excluded within 4 weeks of study entry:
Cytotoxic chemotherapy.
Any retroviral drug including but not limited to zidovudine (AZT), ribavirin, HPA 23, AL721, or phosphonoformate.
Steroids.
Interferon.
+6 more criteria

Contact the study team to confirm eligibility.

Virus Diseases

Dementia

Brain Diseases

Central Nervous System Diseases

Nervous System Diseases

Genital Diseases

Urogenital Diseases

Immunologic Deficiency Syndromes

Immune System Diseases

Neurocognitive Disorders

Mental Disorders

Slow Virus Diseases

Intervention Hierarchy (Ancestors)

ThymidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDideoxynucleosidesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

US

(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Conditions

Keywords

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

Source record

Locations

You may not qualify if:

Intervention Hierarchy (Ancestors)