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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 Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on 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 conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. 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 Clinical research trials and 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 healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including 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. 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 Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a 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 clinical trial. Test subjects typically receive the most effective healthcare possible for their 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 condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > 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  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
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
For Condition: AIDS Dementia Complex,HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: To test whether zidovudine (AZT) is useful as a treatment for the neurologic syndrome called AIDS dementia complex. To determine how long AZT takes to reach cerebral spinal fluid (CSF), how long, and at what concentration it is found there. HIV infection can result in impairment in the function of the brain and spinal cord, leading to disturbances in the ability to think clearly and in strength and coordination. This disorder, which has been called the AIDS dementia complex, may be due to a direct effect of HIV on the nervous system. It is known that AZT does get into the brain to some extent, where it may reduce growth of HIV. It is hoped that AZT will stabilize or improve the symptoms of the AIDS dementia complex.
Details: HIV infection can result in impairment in the function of the brain and spinal cord, leading to disturbances in the ability to think clearly and in strength and coordination. This disorder, which has been called the AIDS dementia complex, may be due to a direct effect of HIV on the nervous system. It is known that AZT does get into the brain to some extent, where it may reduce growth of HIV. It is hoped that AZT will stabilize or improve the symptoms of the AIDS dementia complex. The study is done in 2 stages. In Stage 1, patients are randomized to receive placebo or 1 of 2 doses of AZT. Stage 1 lasts for 4 months. In Stage 2, patients who were initially treated with placebo are randomized again and all patients receive AZT. Stage 2 lasts an additional 12 months, during which time there are periodic medical and neurologic evaluations. Before beginning treatment, all patients have a lumbar puncture and a computerized tomographic (CT) scan of the brain. The lumbar puncture is repeated twice during and once at the end of Stage 1; the CT scan is also repeated at the end of Stage 1. Patients receiving AZT in either stage 1 or Stage 2 are seen by their physicians every week for the first 4 weeks and every other week thereafter for the first 4 months of receiving the drug. After 4 months, patients are seen by their physicians at 4 to 12 week intervals.
Eligibility:
Study Type: Interventional, Treatment, Double-Blind
Minimum Age/Maximum Age: 12 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Aspirin, in modest doses. - Ibuprofen, in modest doses. - Maintenance antibiotic therapy posttherapy for an AIDS-defining opportunistic infection. Concurrent Treatment: Allowed: - Blood transfusion if cardiovascular status is compromised. Exclusion Criteria - Active substance abuse. Co-existing Condition: Patients with the following conditions will be excluded: - Concurrent or previous central nervous system infections or neoplasms. - Active AIDS-defining opportunistic infection. - Severe premorbid psychiatric illness. - Confounding neurological disease. - Concurrent neoplasms. Concurrent Medication: Excluded: - Maintenance methadone or naltrexone. - Acetaminophen. - Mood- or central nervous system-altering drugs. - Zidovudine for Pneumocystis carinii pneumonia (PCP). - Acyclovir. - Rifampin or derivatives. - Drugs with antiretroviral activity. - Experimental agents. The following patients will be excluded from the study: - Patients requiring ongoing therapy for an AIDS-defining opportunistic infection. - Patients with a history of Mycobacterium avium intracellulare infection. - Patients with a history of Pneumocystis carinii pneumonia infection. - Patients with a daily temperature of 38 degrees C or more for 1 month. Prior Medication: Excluded: - Zidovudine (AZT). - Excluded within 14 days of study entry: - Systemic anti-infectives. - Excluded within 30 days of study entry: - Immunomodulators and biologic response modifiers. - Any investigational agent. - Cytotoxic chemotherapy for Kaposi's sarcoma. Prior Treatment: Excluded: - Radiation therapy. Patients must demonstrate the following clinical and laboratory findings: - No currently active AIDS-defining opportunistic infections. - One negative blood culture for Mycobacterium avium intracellulare within 4-6 weeks prior to study entry. - Constitutionally well without persistent fever. - Less than 25 Kaposi's sarcoma lesions and less than 10 new lesions during the 30 days prior to study entry. Patients may have stable or indolently progressive mucocutaneous Kaposi's sarcoma. - Characteristic clinical symptoms and signs of AIDS dementia complex. - Abnormalities on 2 or more of 7 neuropsychological motor tests in the Neurological Screening Battery. - Estimated premorbid IQ equal to or greater than 70 (+ or - 5), which is consistent with completion of sixth grade.
Total Enrollment: 315
Location and Contact Information:
Overall Study Official:
RPrice, Study Chair,
Stanford Univ School of Medicine
Stanford, California, 94305
United States
Charity Hosp / Tulane Univ Med School
New Orleans, Louisiana, 70112
United States
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114
United States
Jack Weiler Hosp / Bronx Municipal Hosp
Bronx, New York, 10465
United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
United States
Mem Sloan - Kettering Cancer Ctr
New York City, New York, 10021
United States
City Hosp Ctr at Elmhurst / Mount Sinai Hosp
Elmhurst, New York, 11373
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, 02215
United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
Bronx, New York, 10461
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
United States
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
Univ of Washington
Seattle, Washington, 98105
United States
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
UCLA CARE Ctr
Los Angeles, California, 90095
United States
Louisiana State Univ Med Ctr / Tulane Med School
New Orleans, Louisiana, 70112
United States
Beth Israel Med Ctr / Peter Krueger Clinic
New York City, New York, 10003
United States
Additional Information:
Study ID Numbers: ACTG 005;
Study Start Date:
Record last reviewed: September 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000702
Other Hiv Infections Studies:
1. Safety and Effectiveness of the Selegiline "Patch" for Decreased Mental Function in HIV Patients
2. The Safety and Effectiveness of Pentamidine in the Prevention of Pneumocystis carinii Pneumonia (PCP) in Patients with AIDS Who Have Had PCP Before
3. A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of r-HuEPO in AIDS Patients With Anemia Induced by Their Disease and AZT Therapy
4. Phase I Trial of the Combination of Zidovudine and Recombinant Interleukin-2 in Patients with Persistent Generalized Lymphadenopathy
5. Phase II Placebo Controlled Study of Thalidomide in Patients With Mycobacterial and HIV Infections
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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
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