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An Open Trial of Zidovudine (AZT) Treatment of the AIDS Dementia Complex in Patients With AIDS or Low CD4+ Lymphocyte Counts Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about An Open Trial of Zidovudine (AZT) Treatment of the AIDS Dementia Complex in Patients With AIDS or Low CD4+ Lymphocyte Counts conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. An Open Trial of Zidovudine (AZT) Treatment of the AIDS Dementia Complex in Patients With AIDS or Low CD4+ Lymphocyte Counts Clinical research trials and An Open Trial of Zidovudine (AZT) Treatment of the AIDS Dementia Complex in Patients With AIDS or Low CD4+ Lymphocyte Counts medical trials take place in many of places 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 usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like An Open Trial of Zidovudine (AZT) Treatment of the AIDS Dementia Complex in Patients With AIDS or Low CD4+ Lymphocyte Counts. An Open Trial of Zidovudine (AZT) Treatment of the AIDS Dementia Complex in Patients With AIDS or Low CD4+ Lymphocyte Counts Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a An Open Trial of Zidovudine (AZT) Treatment of the AIDS Dementia Complex in Patients With AIDS or Low CD4+ Lymphocyte Counts clinical trial. Test subjects typically obtain the finest healthcare available for their An Open Trial of Zidovudine (AZT) Treatment of the AIDS Dementia Complex in Patients With AIDS or Low CD4+ Lymphocyte Counts condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > An Open Trial of Zidovudine (AZT) Treatment of the AIDS Dementia Complex in Patients With AIDS or Low CD4+ Lymphocyte Counts  An Open Trial of Zidovudine (AZT) Treatment of the AIDS Dementia Complex in Patients With AIDS or Low CD4+ Lymphocyte Counts
An Open Trial of Zidovudine (AZT) Treatment of the AIDS Dementia Complex in Patients With AIDS or Low CD4+ Lymphocyte Counts
For Condition: AIDS Dementia Complex,HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: To provide accurate and complete neurologic assessment of the course of the AIDS dementia complex in patients treated with zidovudine (AZT). The study will determine how frequently patients improve, how long improvement is sustained, and the magnitude and functional significance of improvement. Individuals with AIDS frequently suffer central nervous system (CNS) problems that are characterized by cognitive, motor, and behavioral deficits, in a disorder known as AIDS dementia complex. Clinical experience suggests that its course is often progressive, going from initial symptoms to moderate or severe dementia within several months. Accumulating evidence now suggests that direct brain infection by the HIV virus is the likely cause of the AIDS dementia complex. Case reports suggest that therapy with AZT, which has been shown to be a strong inhibitor of HIV replication in vitro, may alleviate the AIDS dementia complex. This study will help define the natural history of the AIDS dementia complex in treated patients.
Details: Individuals with AIDS frequently suffer central nervous system (CNS) problems that are characterized by cognitive, motor, and behavioral deficits, in a disorder known as AIDS dementia complex. Clinical experience suggests that its course is often progressive, going from initial symptoms to moderate or severe dementia within several months. Accumulating evidence now suggests that direct brain infection by the HIV virus is the likely cause of the AIDS dementia complex. Case reports suggest that therapy with AZT, which has been shown to be a strong inhibitor of HIV replication in vitro, may alleviate the AIDS dementia complex. This study will help define the natural history of the AIDS dementia complex in treated patients. All patients receive AZT for 24 weeks. Patients are seen weekly for the first 4 weeks, every other week for the next 8 weeks, and then every 4 weeks until the completion of the study for neuropsychological evaluation. This evaluation includes lumbar puncture, and either computerized tomography or magnetic resonance imaging.
Eligibility:
Study Type: Interventional, Treatment, Open Label
Minimum Age/Maximum Age: 12 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Prophylactic therapy for Pneumocystis carinii pneumonia (PCP); aerosol pentamidine is the preferred method. - Maintenance anticonvulsant therapy following a seizure in the context of the AIDS dementia complex. - Patients taking anticonvulsants should have their anticonvulsant blood levels measured prior to starting zidovudine (AZT) or with changes in AZT dosage. - Phenytoin, carbamazepine, and valproic acid. - Judicious use of benzodiazepams. - For analgesia or fever, modest doses of aspirin, Tylenol, or ibuprofen. - Use of major mood or central nervous system altering drugs is discouraged and should be documented. Patients with the following are included: - An estimated pre-illness IQ = or > 70. - A general neurodiagnostic evaluation before entry which will include a computerized tomographic (CT) scan or magnetic resonance imaging (MRI) scan and a lumbar puncture. - Stable or indolently progressive mucocutaneous Kaposi's sarcoma with < 25 lesions and onset of < 10 new lesions during the 30-day period prior to study entry. - Chronic seizure disorders requiring anticonvulsant therapy as long as the seizures are not associated with a fixed neurologic deficit. - A blood HIV culture and p24 antigen capture assay at the time of the lumbar puncture. A second p24 antigen assay on study entry. Informed consent form must be signed by the patient, legal guardian, or parent. Active substance abuse that would limit a patient's cooperation or evaluation. Exclusion Criteria Co-existing Condition: Patients with the following will be excluded from the study: - Active, symptomatic AIDS-associated opportunistic infections requiring ongoing maintenance therapy. - Persistent fever, active persistent diarrhea, or continued severe weight loss. - Severe premorbid psychiatric illness. - Confounding neurologic disease or deficit. - Concurrent or previous central nervous system infections or neoplasms. - Concurrent active neoplasms other than basal cell carcinoma of the skin and mucocutaneous Kaposi's sarcoma. Concurrent Medication: Excluded: - Major psychotropic medication including tricyclic antidepressants, MAO inhibitors, phenothiazines, butyrophenones, barbiturates, or amphetamines. - Cimetidine. - Ranitidine. - Probenecid. - Indomethacin. - Acyclovir (ACV) prophylaxis for recurrent Herpes simplex. Patients with the following will be excluded from the study: - Active, symptomatic AIDS-associated opportunistic infections requiring ongoing maintenance therapy. - Persistent fever, active persistent diarrhea, or continued severe weight loss. - Severe premorbid psychiatric illness. - Confounding neurologic disease or deficit. - Concurrent or previous central nervous system infections or neoplasms. - Concurrent active neoplasms other than basal cell carcinoma of the skin and mucocutaneous Kaposi's sarcoma. Prior Medication: Excluded within 2 weeks of study entry or for greater than 2 weeks of therapy: - Zidovudine (AZT). - Patients must not have previously exhibited toxic reaction to AZT. - Excluded within 30 days of study entry: - Immunomodulators and biologic response modifiers, including systemic steroids. - Any investigational agent. - Cytotoxic chemotherapy for Kaposi's sarcoma. Prior Treatment: Excluded within 30 days of study entry: - Radiation therapy. - Excluded within 2 weeks of study entry: - Blood transfusion.
Total Enrollment: 50
Location and Contact Information:
Overall Study Official:
RWPrice, Study Chair,
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
Univ Hosp of Cleveland / Case Western Reserve Univ
Cleveland, Ohio, 44106
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Univ of Washington
Seattle, Washington, 98105
United States
Mem Sloan - Kettering Cancer Ctr
New York City, New York, 10021
United States
UCLA CARE Ctr
Los Angeles, California, 90095
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Louisiana State Univ Med Ctr / Tulane Med School
New Orleans, Louisiana, 70112
United States
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112
United States
Charity Hosp / Tulane Univ Med School
New Orleans, Louisiana, 70112
United States
Additional Information:
Study ID Numbers: ACTG 061;
Study Start Date:
Record last reviewed: May 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000709
Other Hiv Infections Studies:
1. A Study to Evaluate the Safety and Tolerance of Nelfinavir (NFV) Given with Zidovudine (ZDV) and Lamivudine (3TC) in HIV-Positive Pregnant Women and Their Infants
2. Effect of Vaccination on Turnover of Lamivudine (3TC) Sensitive and Resistant Virus Populations in HIV-1-Infected Individuals
3. The Safety and Effectiveness of Lamivudine Plus Zidovudine, Used with and without 1592U89, in HIV-1 Infected Patients Who Have Never Taken Anti-HIV Drugs
4. A Study of the Safety and Efficacy of Chronically Administered MDL 28,574A in the Treatment of HIV-Infected Patients
5. A Clinical Research Study Of FDA-Approved HIV Drugs In HIV-Infected Patients Who Have Not Received Prior Therapy
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An Open Trial of Zidovudine (AZT) Treatment of the AIDS Dementia Complex in Patients With AIDS or Low CD4+ Lymphocyte Counts
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