Evaluation of the Interaction Between Acetaminophen and Zidovudine
|Study Design:||Endpoint Classification: Pharmacokinetics Study
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of the Interaction Between Acetaminophen and Zidovudine|
|Study Completion Date:||May 1990|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000731
|United States, Pennsylvania|
|Univ of Pittsburgh Med School|
|Pittsburgh, Pennsylvania, United States|
|Study Chair:||Ptachcinski R|