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CompletedNCT00002044Updated Jun 24, 2005

A Pilot Study To Evaluate the Effect of Retrovir (Zidovudine: AZT) in the Treatment of Human Immunodeficiency Virus (HIV) Associated Dementia and Neuromuscular Diseases

An interventional study of Zidovudine in AIDS Dementia Complex, Neuromuscular Diseases and HIV Infections, sponsored by Glaxo Wellcome. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2005-06-24.

Sponsored by Glaxo Wellcome (part of GlaxoSmithKline) · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • AIDS Dementia Complex
  • Neuromuscular Diseases
  • HIV Infections

Keywords

  • Pilot Projects
  • Neuromuscular Diseases
  • Drug Evaluation
  • Acquired Immunodeficiency Syndrome
  • AIDS Dementia Complex
  • AIDS-Related Complex
  • Zidovudine
03

In context

AIDS Dementia Complex

41 studies on the registry are indexed under AIDS Dementia Complex; 2 are open to participants now.

Browse AIDS Dementia Complex studies →

Lead sponsor

Glaxo Wellcome is the lead sponsor of 72 studies on the registry; none are open to participants now.

First submitted before Glaxo Wellcome became part of GlaxoSmithKline.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Co-existing Condition:

Patients with the following are excluded:

  • 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 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.
  • to zidovudine (AZT).
  • Lymphoma or other tumor requiring cytotoxic chemotherapy.

Concurrent Treatment:

Allowed:

  • Electron beam therapy to an area of less than 100 cm2.

Patients with the following are excluded:

  • 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.

Patients with AIDS (CDC surveillance definition) or AIDS related complex (ARC).

  • All patients must have either:
  • Dementia as defined by a progressive cognitive impairment in the absence of altered consciousness that is thought to be causally related to HIV infection. Patients in this study will fall into the lower 20 percent (or less) of a normal sample of formal neuropsychological testing.
  • OR
  • One of the following neuromuscular diseases thought to be related to HIV infection:
  • Demyelinating polyneuropathy, axonal polyneuropathy, inflammatory myopathy, or unexplained progressive muscle weakness.
  • Capacity to give or a person with durable power of attorney who can give informed consent.
  • = or > 4 months.

Exclusion criteria

Exclusion Criteria

Concurrent Medication:

Excluded:

  • Cytotoxic chemotherapy.
  • .
  • 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.
  • Immunomodulating agents.
  • An anticipated need for any of these agents within the next 16 weeks.

Prior Treatment:

Excluded within 1 month of study entry:

  • Radiation therapy (except electron beam therapy to an area of less than 100 cm2).
  • Blood transfusion.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment

Interventions

06

Study locations

1 site
  • Glaxo Wellcome Inc
    Research Triangle Park, North Carolina 27709, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00002044
Lead sponsor
Glaxo Wellcome
First posted
Aug 31, 2001
Last update
Jun 24, 2005
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 1995. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Zidovudine

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