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A Pilot Study To Evaluate the Effect of Retrovir (Zidovudine: AZT) in the Treatment of Human Immunodeficiency Virus (HIV) Associated Dementia and Neuromuscular Diseases Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on A Pilot Study To Evaluate the Effect of Retrovir (Zidovudine: AZT) in the Treatment of Human Immunodeficiency Virus (HIV) Associated Dementia and Neuromuscular Diseases conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A Pilot Study To Evaluate the Effect of Retrovir (Zidovudine: AZT) in the Treatment of Human Immunodeficiency Virus (HIV) Associated Dementia and Neuromuscular Diseases Clinical research trials and A Pilot Study To Evaluate the Effect of Retrovir (Zidovudine: AZT) in the Treatment of Human Immunodeficiency Virus (HIV) Associated Dementia and Neuromuscular Diseases medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like 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 Pilot Study To Evaluate the Effect of Retrovir (Zidovudine: AZT) in the Treatment of Human Immunodeficiency Virus (HIV) Associated Dementia and Neuromuscular Diseases Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a A Pilot Study To Evaluate the Effect of Retrovir (Zidovudine: AZT) in the Treatment of Human Immunodeficiency Virus (HIV) Associated Dementia and Neuromuscular Diseases clinical trial. Participants frequently obtain the most expert healthcare available for their A Pilot Study To Evaluate the Effect of Retrovir (Zidovudine: AZT) in the Treatment of Human Immunodeficiency Virus (HIV) Associated Dementia and Neuromuscular Diseases condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > 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 Pilot Study To Evaluate the Effect of Retrovir (Zidovudine: AZT) in the Treatment of Human Immunodeficiency Virus (HIV) Associated Dementia and Neuromuscular Diseases
A Pilot Study To Evaluate the Effect of Retrovir (Zidovudine: AZT) in the Treatment of Human Immunodeficiency Virus (HIV) Associated Dementia and Neuromuscular Diseases
For Condition: AIDS Dementia Complex,Neuromuscular Diseases,HIV Infections
Status: Completed
Sponsor(s): Glaxo Wellcome ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Dose Comparison
Minimum Age/Maximum Age: 18 Years/70 Years
Genders: Both
Protocol Entry Criteria: 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 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. Exclusion Criteria 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. - 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.
Total Enrollment:
Location and Contact Information:
Glaxo Wellcome Inc
Research Triangle Park, North Carolina, 27709
United States
Additional Information:
Study ID Numbers: 014D; 14
Study Start Date:
Record last reviewed: February 1995
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002044
Other Aids Dementia Complex Studies:
1. Interactions Between HIV Protease Inhibitors and Calcium Channel Blockers
2. Anti-HIV Drugs During Pregnancy
3. Antibiotics to Reduce Chorioamnionitis-Related Perinatal HIV Transmission
4. Preventive Treatment Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Confirmed Latent Tuberculous Infection
5. A Study of Three Drug Combination Therapies in HIV-Infected Patients Who Have Never Been Treated with Anti-HIV Drugs
Related Studies:
Other AIDS Dementia Complex Clinical Trials
Other North Carolina Clinical Trials
Other Research Triangle Park Clinical Trials
A Pilot Study To Evaluate the Effect of Retrovir (Zidovudine: AZT) in the Treatment of Human Immunodeficiency Virus (HIV) Associated Dementia and Neuromuscular Diseases
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