Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000772
Status:
COMPLETED
Last Update Posted:
2021-10-28
First Post:
1999-11-02
Brief Title:
A Phase I Open-Label Study of the Safety Tolerance and Pharmacokinetic Interactions of Combination Didanosine and Ribavirin in HIV-Positive Individuals
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 Open-Label Study of the Safety Tolerance and Pharmacokinetic Interactions of Combination Didanosine and Ribavirin in HIV-Positive Individuals
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 evaluate the safety and tolerance of concurrent administration of standard-dose didanosine ddI with low-dose ribavirin in HIV-positive patients To determine the pharmacokinetic interactions of concurrent administration of ddI and ribavirin and correlate pharmacokinetic parameters with toxicity To investigate antiviral activity of the combined regimen
Combination ddIribavirin therapy if safe and effective offers an alternative combination antiretroviral regimen for patients unable to tolerate regimens containing zidovudine AZT
Combination ddIribavirin therapy if safe and effective offers an alternative combination antiretroviral regimen for patients unable to tolerate regimens containing zidovudine AZT
Detailed Description:
Combination ddIribavirin therapy if safe and effective offers an alternative combination antiretroviral regimen for patients unable to tolerate regimens containing zidovudine AZT
Patients receive ddI alone for 4 weeks followed by 8 weeks of combination ddIribavirin Patients who complete the first 12 weeks without major toxicity may receive an additional 12 weeks of combination therapy on an optional basis Patients are followed for 60 days after the last treatment visit
Patients receive ddI alone for 4 weeks followed by 8 weeks of combination ddIribavirin Patients who complete the first 12 weeks without major toxicity may receive an additional 12 weeks of combination therapy on an optional basis Patients are followed for 60 days after the last treatment visit
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 |
|---|---|---|---|
| 11208 | REGISTRY | DAIDS ES Registry Number | None |