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| Descriptive Information Fields | |||||
| Brief Title † | Evaluation of the Interaction Between Acetaminophen and Zidovudine | ||||
| Official Title † | Evaluation of the Interaction Between Acetaminophen and Zidovudine | ||||
| Brief Summary | To determine if zidovudine (AZT) and acetaminophen (APAP) interact when given to the same patient, and if so, the manner of interaction. Patients with AIDS often require therapy with painkillers for the management of mild pain and discomfort associated with their disease, and APAP is often prescribed. AZT is being used to treat AIDS patients. It is important for doctors to understand how AZT and APAP may interact when given to the same patient, because other studies have suggested that the dosage of AZT may have to be adjusted when given with APAP in order to avoid or minimize adverse effects. |
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| Detailed Description | Patients with AIDS often require therapy with painkillers for the management of mild pain and discomfort associated with their disease, and APAP is often prescribed. AZT is being used to treat AIDS patients. It is important for doctors to understand how AZT and APAP may interact when given to the same patient, because other studies have suggested that the dosage of AZT may have to be adjusted when given with APAP in order to avoid or minimize adverse effects. Persons who are infected with HIV and have symptoms (fever, fatigue, weight loss) of AIDS are eligible for the study. They will be given AZT orally every 4 hours or APAP orally every 8 hours alone or in combination for 4 days while at home. On the 4th day, participants will be admitted to a clinical research center for studies to determine how they are tolerating the medicine. On the 5th day, any scheduled 8 am doses of AZT will be given intravenously, while the scheduled doses of APAP will still be given orally. Repeated blood samples will be taken over the next 12 hours and urine will be collected for 24 hours. The process will be repeated at weekly intervals for 3 weeks, so that each patient receives AZT alone, APAP alone, and the combination of AZT and APAP. |
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| Study Phase | |||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Open Label, Pharmacokinetics Study | ||||
| Primary Outcome Measure † | |||||
| Secondary Outcome Measure † | |||||
| Condition † | HIV Infections | ||||
| Intervention † | Drug: Zidovudine Drug: Acetaminophen |
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| MEDLINE PMIDs | 2024860 | ||||
| Links | Click here for more information about Zidovudine ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | 10 | ||||
| Start Date † | |||||
| Completion Date | |||||
| Eligibility Criteria † | Exclusion Criteria Co-existing Condition: Patients with the following are excluded:
Patients with the following are excluded:
AIDS related complex (ARC) defined as presence of any one of the following within 12 months prior to entry and absence of a concurrent illness or condition other than HIV infection to explain the findings:
Inability to abstain from alcohol or any other drug, including nonprescription medications, during the study period. |
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| Gender | Both | ||||
| Ages | 18 Years to 50 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00000731 | ||||
| Organization ID | ACTG 032 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | National Institute of Allergy and Infectious Diseases (NIAID) | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | National Institute of Allergy and Infectious Diseases (NIAID) | ||||
| Verification Date | October 1991 | ||||
| First Received Date † | November 2, 1999 | ||||
| Last Updated Date | July 29, 2008 | ||||