A Pilot Study To Evaluate the Effect of Retrovir (Zidovudine: AZT) in the Treatment of Human Immunodeficiency Virus (HIV) Associated Dementia and Neuromuscular Diseases
2 other identifiers
interventional
N/A
1 country
1
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.
Trial Health
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
February 1, 1995
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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 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.
Sponsors & Collaborators
- Glaxo Wellcomelead
Study Sites (1)
Glaxo Wellcome Inc
Research Triangle Park, North Carolina, 27709, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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