Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000731
Status:
COMPLETED
Last Update Posted:
2021-11-03
First Post:
1999-11-02
Brief Title:
Evaluation of the Interaction Between Acetaminophen and Zidovudine
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Evaluation of the Interaction Between Acetaminophen and Zidovudine
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 11008 | REGISTRY | DAIDS ES Registry Number | None |