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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 Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about 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 site dedicated 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 health trials happen in many of localities throughout the U.S.. 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 drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like 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 volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes 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. Human subjects often get the best healthcare available 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. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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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. A Phase II/III Study of Cysteamine (Mercaptoethylamine) and Zidovudine for the Treatment of HIV Disease
2. A Study of Itraconazole in Preventing the Return of Histoplasmosis, a Fungal Infection, in Patients with AIDS
3. Kidney and Liver Transplantation in People with HIV
4. Phase III Randomized Double-Blind Study Comparing Megestrol Acetate at 800 mg/day, and Placebo in AIDS Patients With Anorexia and Cachexia
5. Effects of Storage on Lactate in Blood Samples
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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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