Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000732
Status:
COMPLETED
Last Update Posted:
2021-11-03
First Post:
1999-11-02
Brief Title:
Evaluation of the Interaction Between Low Dose Sulfamethoxazole-Trimethoprim 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 Low Dose TrimethoprimSulfamethoxazole 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 the pharmacokinetics of low doses of zidovudine AZT that is how fast AZT reaches the blood what concentration of AZT is attained in the blood and how long AZT remains in the blood changes from day-to-day in the same patient Also to determine whether the pharmacokinetics of AZT is changed by sulfamethoxazoletrimethoprim SMXTMP given at the same time or whether the pharmacokinetics of SMXTMP is altered by AZT therapy AZT has been effective in treating some patients with AIDS and SMXTMP is an antibiotic combination which is useful in preventing or treating Pneumocystis carinii pneumonia PCP which is an important cause of disease and death in patients with AIDS It is important to know how drugs interact in patients because addition of a second drug may change the speed at which a drug is eliminated from the body and cause increased toxic effects or decreased therapeutic effects
Detailed Description:
AZT has been effective in treating some patients with AIDS and SMXTMP is an antibiotic combination which is useful in preventing or treating Pneumocystis carinii pneumonia PCP which is an important cause of disease and death in patients with AIDS It is important to know how drugs interact in patients because addition of a second drug may change the speed at which a drug is eliminated from the body and cause increased toxic effects or decreased therapeutic effects
Patients take AZT every 4 hours andor SMXTMP every 12 hours by mouth for 4 days as outpatients and then come into the clinical research center for 2 days of studies On day 5 the final dose of medicine is given orally SMXTMP or by intravenous infusion AZT Blood samples are drawn 10-20 times over a period of 12 hours and urine is collected for 36 hours Concentrations of the drugs in the blood and urine samples are determined This sequence is repeated twice so that each patient takes AZT alone SMXTMP alone and the combination of AZT and SMXTMP over a period of about 3 weeks Patients may be included in the study if they are asymptomatic or have been diagnosed with ARC or AIDS but not if they have PCP or any other severe opportunistic infection
Patients take AZT every 4 hours andor SMXTMP every 12 hours by mouth for 4 days as outpatients and then come into the clinical research center for 2 days of studies On day 5 the final dose of medicine is given orally SMXTMP or by intravenous infusion AZT Blood samples are drawn 10-20 times over a period of 12 hours and urine is collected for 36 hours Concentrations of the drugs in the blood and urine samples are determined This sequence is repeated twice so that each patient takes AZT alone SMXTMP alone and the combination of AZT and SMXTMP over a period of about 3 weeks Patients may be included in the study if they are asymptomatic or have been diagnosed with ARC or AIDS but not if they have PCP or any other severe opportunistic infection
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 |
|---|---|---|---|
| 11009 | REGISTRY | DAIDS ES Registry Number | None |