Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000833
Status:
COMPLETED
Last Update Posted:
2021-10-28
First Post:
1999-11-02
Brief Title:
A Phase I Study of Combination Therapy With Didanosine ddI and Ribavirin in HIV-Infected Children
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 Study of Combination Therapy With Didanosine ddI and Ribavirin in HIV-Infected Children
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 compare the safety toxicity and tolerance of two doses of ribavirin in combination with didanosine ddI to HIV-infected children To determine the toxicity of ddIribavirin and compare it to the expected toxicity of ddI monotherapy To determine the effect of concurrent ribavirin on the pharmacokinetics of ddI To determine a dosage of ribavirin that would be suitable for a Phase IIIII evaluation of ddIribavirin
Ribavirin a broad spectrum antiviral agent may enhance the antiretroviral activity of didanosine ddI without a concomitant increase in toxicity Ribavirin alters the intracellular metabolism of ddI enhancing the antiretroviral activity of the active form of ddI
Ribavirin a broad spectrum antiviral agent may enhance the antiretroviral activity of didanosine ddI without a concomitant increase in toxicity Ribavirin alters the intracellular metabolism of ddI enhancing the antiretroviral activity of the active form of ddI
Detailed Description:
Ribavirin a broad spectrum antiviral agent may enhance the antiretroviral activity of didanosine ddI without a concomitant increase in toxicity Ribavirin alters the intracellular metabolism of ddI enhancing the antiretroviral activity of the active form of ddI
Patients are divided into two cohorts Subjects will be stratified by age 3 months to 24 months and 24 months to 12 years Fifty of patients from each age group will be assigned to each cohort Cohort 1 receives ddI monotherapy for 4 weeks followed by combination ddlribavirin therapy for an additional 20 weeks Cohort 2 receives combination ddIribavirin for 24 weeks In both cohorts after study medications are stopped patients are treated with prescription antiretrovirals for 4 more weeks AS PER AMENDMENT 7296 Note In each cohort of 10 subjects at least 2 of 5 children from the older half of the cohort will have an ICD p24 antigen at entry
Patients are divided into two cohorts Subjects will be stratified by age 3 months to 24 months and 24 months to 12 years Fifty of patients from each age group will be assigned to each cohort Cohort 1 receives ddI monotherapy for 4 weeks followed by combination ddlribavirin therapy for an additional 20 weeks Cohort 2 receives combination ddIribavirin for 24 weeks In both cohorts after study medications are stopped patients are treated with prescription antiretrovirals for 4 more weeks AS PER AMENDMENT 7296 Note In each cohort of 10 subjects at least 2 of 5 children from the older half of the cohort will have an ICD p24 antigen at entry
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 |
|---|---|---|---|
| 11250 | REGISTRY | DAIDS ES Registry Number | None |