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A Safety, Pilot Pharmacokinetics and Neurocognitive Study of AS-101 in Combination With Zidovudine in AIDS/ARC Patients Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about A Safety, Pilot Pharmacokinetics and Neurocognitive Study of AS-101 in Combination With Zidovudine in AIDS/ARC Patients conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A Safety, Pilot Pharmacokinetics and Neurocognitive Study of AS-101 in Combination With Zidovudine in AIDS/ARC Patients Clinical research trials and A Safety, Pilot Pharmacokinetics and Neurocognitive Study of AS-101 in Combination With Zidovudine in AIDS/ARC Patients medical trials happen in hundreds 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 usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as A Safety, Pilot Pharmacokinetics and Neurocognitive Study of AS-101 in Combination With Zidovudine in AIDS/ARC Patients. A Safety, Pilot Pharmacokinetics and Neurocognitive Study of AS-101 in Combination With Zidovudine in AIDS/ARC Patients Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a A Safety, Pilot Pharmacokinetics and Neurocognitive Study of AS-101 in Combination With Zidovudine in AIDS/ARC Patients clinical trial. Participants frequently get the best healthcare available for their A Safety, Pilot Pharmacokinetics and Neurocognitive Study of AS-101 in Combination With Zidovudine in AIDS/ARC Patients condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Safety, Pilot Pharmacokinetics and Neurocognitive Study of AS-101 in Combination With Zidovudine in AIDS/ARC Patients  A Safety, Pilot Pharmacokinetics and Neurocognitive Study of AS-101 in Combination With Zidovudine in AIDS/ARC Patients
A Safety, Pilot Pharmacokinetics and Neurocognitive Study of AS-101 in Combination With Zidovudine in AIDS/ARC Patients
For Condition: HIV Infections
Status: Completed
Sponsor(s): Wyeth-Ayerst Research ,
Synopsis: To evaluate safety, pharmacokinetics, immunologic parameters and neurocognitive data for three dosages of AS-101 in combination with zidovudine (AZT) in patients with AIDS or AIDS related complex (ARC).
Details:
Eligibility:
Study Type: Interventional, Treatment, Dose Comparison, Pharmacokinetics Study
Minimum Age/Maximum Age: 18 Years/60 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Required: - Zidovudine (AZT). - Aerosolized pentamidine for Pneumocystis carinii pneumonia (PCP) prophylaxis. - Allowed ONLY with permission of the Wyeth-Ayerst medical monitor: - Standard therapy for infections that develop during the study period. - Oral acyclovir. - Nystatin. - Ketoconazole. - Immunomodulators. - Specific therapy for malignancies (including Kaposi's sarcoma). Patients must have the following: - Diagnosis of AIDS or AIDS related complex (ARC). - Provide informed written consent. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: - Active opportunistic infection or malignancy requiring treatment at study entry. - Prior history of psychiatric illness or head injury which in the judgment of the neuropsychologist would impair interpretation of the neurocognitive data. - Evidence of central nervous system (CNS) opportunistic infection or malignancy. - Serious underlying medical problems, including insulin- dependent diabetes mellitus, unstable ASHD (atherosclerotic heart disease) or uncontrolled hypertension, which may complicate interpretation of treatment results. - Dementia. - Evidence of = or > 2 + proteinuria at study entry. Concurrent Medication: Excluded without permission of the Wyeth-Ayerst medical monitor: - Immunomodulators. - Specific therapy for malignancies (including Kaposi's sarcoma). Patients with the following are excluded: - Active opportunistic infection or malignancy requiring treatment at study entry. - Prior history of psychiatric illness or head injury which in the judgment of the neuropsychologist would impair interpretation of the neurocognitive data. - Evidence of conditions listed in the Patient Exclusion Co-existing Conditions. - Active substance abuse. - Unlikely or unable to comply with the requirements of the protocol. Prior Medication: Excluded within 8 weeks of study entry: - Immunomodulators. - Antiviral therapy, except zidovudine. - Excluded within 2 weeks of study entry: - Intravenous or oral acyclovir. - Excluded within 3 months of study entry: - Ribavirin. Required: - Zidovudine at a dose of = or > 1000 mg/day for at least 6 weeks prior to study entry. Active substance abuse.
Total Enrollment:
Location and Contact Information:
Los Angeles County - USC Med Ctr
Los Angeles, California, 900331084
United States
Additional Information:
Study ID Numbers: 045C; 753A-109-US
Study Start Date:
Record last reviewed: December 1990
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002013
Other Hiv Infections Studies:
1. An Ascending, Single Oral Dose Pharmacokinetic Study of 3'-Deoxy-3'-Fluorothymidine (FLT) in Asymptomatic Human Immunodeficiency Virus (HIV)-Infected Subjects
2. HIV Prevention Preparedness Study in Russia, China, and India
3. Acupressure to Treat Nausea and Vomiting in HIV/AIDS Patients
4. A Pilot Study of Adherence to Oral Medication and Health Beliefs of Adolescents with HIV and their Mothers
5. A Study of MKC-442 in Combination with Other Anti-HIV Drugs
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A Safety, Pilot Pharmacokinetics and Neurocognitive Study of AS-101 in Combination With Zidovudine in AIDS/ARC Patients
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