Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000710
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
A Phase I Safety Efficacy and Pharmacokinetic Study of 23-Dideoxyinosine ddI Administered Twice Daily to Patients With AIDS or AIDS Related Complex
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase I Safety Efficacy and Pharmacokinetic Study of 23-Dideoxyinosine ddI Administered Twice Daily to Patients With AIDS or AIDS Related Complex
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 the safety pharmacokinetics blood levels and effectiveness of didanosine ddI when administered both intravenously and orally After the maximum tolerated dose MTD is determined an appropriate dosage regimen will then be established for Phase II and Phase III trials
Zidovudine AZT has produced the best clinical results in the drug therapy of AIDS to date but it produces toxicity in approximately 50 percent of patients Early data show that ddI possesses high antiviral activity and less toxicity than AZT The most effective route and dose of ddI has yet to be determined
Zidovudine AZT has produced the best clinical results in the drug therapy of AIDS to date but it produces toxicity in approximately 50 percent of patients Early data show that ddI possesses high antiviral activity and less toxicity than AZT The most effective route and dose of ddI has yet to be determined
Detailed Description:
Zidovudine AZT has produced the best clinical results in the drug therapy of AIDS to date but it produces toxicity in approximately 50 percent of patients Early data show that ddI possesses high antiviral activity and less toxicity than AZT The most effective route and dose of ddI has yet to be determined
Patients are given intravenous drug for 14 days with a 1 day washout period then 76 weeks of oral medication To expedite this safety study and still be able to maintain close monitoring of the patients health an overlapping dosing regimen is used After 6 patients have been enrolled and at least 4 have completed 4 weeks of dosing without significant toxic effects a second group of patients is started at the next dose level
AMENDED An alternative oral dosing formulation of ddI will be provided as a buffer powder blend packaged in sealed foil sachets in several strengths
Patients are given intravenous drug for 14 days with a 1 day washout period then 76 weeks of oral medication To expedite this safety study and still be able to maintain close monitoring of the patients health an overlapping dosing regimen is used After 6 patients have been enrolled and at least 4 have completed 4 weeks of dosing without significant toxic effects a second group of patients is started at the next dose level
AMENDED An alternative oral dosing formulation of ddI will be provided as a buffer powder blend packaged in sealed foil sachets in several strengths
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 |
|---|---|---|---|
| 11038 | REGISTRY | DAIDS ES Registry Number | None |