AIDS Dementia ComplexNCT00002044
A Pilot Study To Evaluate the Effect of Retrovir (Zidovudine: AZT) in the Treatment of Human Immunodeficiency Virus (HIV) Associated Dementia and Neuromuscular Diseases
A study testing Zidovudine in people with AIDS Dementia Complex and Neuromuscular Diseases, run by Glaxo Wellcome at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- AIDS Dementia Complex, Neuromuscular Diseases, HIV Infections
- What is being tested?
- Zidovudine
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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:
- 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 informed consent or a person with durable power of attorney who can give informed consent.
- Life expectancy = or > 4 months.
Who cannot join
- Concurrent Medication:
- Excluded:
- Cytotoxic chemotherapy.
- Steroids.
- Interferon.
- Immunomodulating agents.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Glaxo Wellcome Inc
Research Triangle Park, North Carolina, 27709
About this study
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.
- Being tested
- Zidovudine
- Keywords
- Pilot Projects, Neuromuscular Diseases, Drug Evaluation, Acquired Immunodeficiency Syndrome, AIDS Dementia Complex, AIDS-Related Complex, Zidovudine
- Medical subject headings
- AIDS Dementia Complex, Neuromuscular Diseases, HIV Infections, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZidovudineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AIDS Dementia ComplexStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Glaxo Wellcome
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002044
- Sponsor's protocol ID
- 014D
- Other IDs
- 14
- Status last verified
- Feb 1995
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study To Evaluate the Effect of Retrovir (Zidovudine: AZT) in the Treatment of Human Immunodeficiency Virus (HIV) Associated Dementia and Neuromuscular Diseases
- ClinicalTrials.gov ID
- NCT00002044
- Acronym / sponsor ID
- 014D
- Keywords
- Pilot Projects, Neuromuscular Diseases, Drug Evaluation, Acquired Immunodeficiency Syndrome, AIDS Dementia Complex, AIDS-Related Complex, Zidovudine
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Glaxo WellcomeIndustry (pharma, biotech, devices)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (36 listed)
- Past or present renal disease.
- Significant bone marrow suppression.
- Blood transfusion within the past month.
- Liver dysfunction.
- Evidence of an underlying, severe infection.
Key exclusion criteria (21 listed)
- Cytotoxic chemotherapy.
- Steroids.
- Interferon.
- Immunomodulating agents.
- Radiation therapy (except electron beam therapy to an area of less than 100 cm2).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zidovudine | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zidovudine in people with AIDS Dementia Complex and Neuromuscular Diseases, run by Glaxo Wellcome at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 36 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.