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A Phase III, Randomized, Double-Blind, Multicentre Study to Evaluate the Safety and Efficacy of 1592U89 in Patients With AIDS Dementia Complex Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about A Phase III, Randomized, Double-Blind, Multicentre Study to Evaluate the Safety and Efficacy of 1592U89 in Patients With AIDS Dementia Complex conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A Phase III, Randomized, Double-Blind, Multicentre Study to Evaluate the Safety and Efficacy of 1592U89 in Patients With AIDS Dementia Complex Clinical research trials and A Phase III, Randomized, Double-Blind, Multicentre Study to Evaluate the Safety and Efficacy of 1592U89 in Patients With AIDS Dementia Complex health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including A Phase III, Randomized, Double-Blind, Multicentre Study to Evaluate the Safety and Efficacy of 1592U89 in Patients With AIDS Dementia Complex. A Phase III, Randomized, Double-Blind, Multicentre Study to Evaluate the Safety and Efficacy of 1592U89 in Patients With AIDS Dementia Complex Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a A Phase III, Randomized, Double-Blind, Multicentre Study to Evaluate the Safety and Efficacy of 1592U89 in Patients With AIDS Dementia Complex clinical trial. Human subjects often get the best healthcare possible for their A Phase III, Randomized, Double-Blind, Multicentre Study to Evaluate the Safety and Efficacy of 1592U89 in Patients With AIDS Dementia Complex condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Phase III, Randomized, Double-Blind, Multicentre Study to Evaluate the Safety and Efficacy of 1592U89 in Patients With AIDS Dementia Complex  A Phase III, Randomized, Double-Blind, Multicentre Study to Evaluate the Safety and Efficacy of 1592U89 in Patients With AIDS Dementia Complex
A Phase III, Randomized, Double-Blind, Multicentre Study to Evaluate the Safety and Efficacy of 1592U89 in Patients With AIDS Dementia Complex
For Condition: AIDS Dementia Complex,HIV Infections
Status: Completed
Sponsor(s): Glaxo Wellcome ,
Synopsis: To evaluate the benefit of adding 1592U89 to current antiretroviral therapies for AIDS dementia complex and to assess the safety and tolerance of the treatment regimens.
Details: Patients must be on stable antiretroviral treatment for at least 6 weeks prior to study entry and will then be stratified depending on whether their regimen contains zidovudine (ZDV). Each stratum will be randomized separately to receive 1592U89 or placebo for 12 weeks. For the subsequent 40 weeks, open-label 1592U89 will be offered.
Eligibility:
Study Type: Interventional, Treatment, Double-Blind, Safety Study
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients must have: - Documented HIV infection. - Evidence of HIV - associated dementia. - Been on stable antiretroviral treatment for a minimum of 6 weeks prior to study entry. Exclusion Criteria Co-existing Condition: Patients with any of the following symptoms or conditions are excluded: - Debilitated as a result of their HIV disease, associated illness or therapies who the investigator determines will not be able to complete the 12 week randomized dosing period. - Memorial Sloan-Kettering (MSK) score of >= 3 for dementia. - Confounding neurological diseases which may interfere with interpretation of neurological and neurophysical assessments. - Malabsorption syndrome or other gastrointestinal dysfunction which renders them unable to take oral medication. - Chronic diseases such as diabetes, congestive heart failure, cardiomyopathy, other cardiac dysfunctions, etc., which in the investigator's opinion would compromise the safety of the patient. - Symptomatic AIDS-defining opportunistic infection not responsive to therapy. Concurrent Medication: Excluded: - Treatment with cytotoxic chemotherapeutic agents within the first 12 weeks of the study. - Treatment with nerve growth factor within the first 12 weeks of study. - The use of narcotic analgesics, sedatives, benzodiazepines, antidepressants, anti-psychotic agents and other psychoactive drugs which would interfere with the assessment of the neurological and neurophysical status of the patient. - Use of stavudine (d4T) during the first 12 weeks of the study. - Immunomodulating agents (except GM/G-CSF or epoietin). - Psychoactive drugs (at the investigator's discretion). Concurrent Treatment: Excluded: - Treatment with radiation therapy within the first 12 weeks of the study. NOTE: - With the exception of local treatment for Kaposi's sarcoma. Patients with any of the following prior conditions are excluded: - Previous neurological disease unrelated to HIV infection. - History of clinically apparent hepatitis within the last 6 months. - History of clinically apparent pancreatitis in the last 6 months. Prior Medication: Excluded: - Treatment with cytotoxic chemotherapeutic agents within 1 month of entry. - Participation in investigational antiretroviral trials within the past 3 months. - HIV vaccine within the past 3 months. - Treatment with immunomodulating agents such as systemic corticosteroids, interleukins, thalidomide, anticytokine agents, anti-oxidants or interferons within 1 month of study entry. - Nerve growth factor. Prior Treatment: Excluded: - Treatment with radiation therapy within 1 month of entry. NOTE: - With the exception of local treatment for Kaposi's sarcoma. Risk Behavior: Excluded: Current alcohol or illicit drug use which may interfere with the patient's ability to comply with the study protocol. Required: - Stable antiretroviral treatment that has been ongoing for a minimum of 6 weeks prior to study entry, may or may not include ZDV. Required: - Stable antiretroviral treatment for a minimum of 6 weeks prior to study entry.
Total Enrollment:
Location and Contact Information:
Johns Hopkins Univ School of Medicine
Baltimore, Maryland, 21287
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
Wellesley Hosp
Toronto, Ontario,
Canada
Univ of Manitoba / Faculty of Medicine
Winnipeg, Manitoba,
Canada
HIV Neurobehavioral Research Ctr
San Diego, California, 92103
United States
San Francisco Gen Hosp
San Francisco, California, 94110
United States
Washington Univ Med Ctr
St. Louis, Missouri, 63110
United States
Columbia Univ / Sergievsky Ctr
New York City, New York, 10032
United States
Univ of North Carolina School of Medicine
Chapel Hill, North Carolina, 27599
United States
Additional Information:
Study ID Numbers: 238B; CNAB 3001
Study Start Date:
Record last reviewed: November 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002163
Other Hiv Infections Studies:
1. Comparison of 2',3'-Dideoxyinosine (Didanosine, ddI) and Zidovudine in Therapy of Patients With the AIDS Dementia Complex
2. A Pilot Study To Evaluate the Effect of Retrovir (Zidovudine: AZT) in the Treatment of Human Immunodeficiency Virus (HIV) Associated Dementia and Neuromuscular Diseases
3. An Open Trial of Zidovudine (AZT) Treatment of the AIDS Dementia Complex in Patients With AIDS or Low CD4+ Lymphocyte Counts
4. A Study to Evaluate the Use of Memantine In Combination with Anti-HIV Drugs to Treat AIDS Dementia Complex (ADC)
5. A Multicenter Placebo-Controlled Double-Blind Trial to Evaluate Azidothymidine (AZT) Treatment of the AIDS Dementia Complex and Central Nervous System (CNS) Human Immunodeficiency Virus (HIV) Infection
Related Studies:
Other HIV Infections Clinical Trials
Other North Carolina Clinical Trials
Other Chapel Hill Clinical Trials
A Phase III, Randomized, Double-Blind, Multicentre Study to Evaluate the Safety and Efficacy of 1592U89 in Patients With AIDS Dementia Complex
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