Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000652
Status:
COMPLETED
Last Update Posted:
2012-11-01
First Post:
1999-11-02
Brief Title:
A Phase I Study to Evaluate the Safety and Toxicity of the Combination of Zidovudine and 23-Dideoxyinosine Didanosine in Children With HIV Infection
Sponsor:
National Cancer Institute NCI
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase I Study to Evaluate the Safety and Toxicity of the Combination of Zidovudine and 23-Dideoxyinosine Didanosine in Children With HIV Infection
Status:
COMPLETED
Status Verified Date:
2012-10
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 assess the safety and tolerance of the combination of zidovudine AZT and didanosine ddI in children with HIV infection
New approaches to using available agents may provide increased or improved treatment options for AIDS Combination therapy is expected to play a major role in improving survival and quality of life for HIV-infected individuals AZT and ddI are two agents that have been most extensively evaluated and for which the evidence for antiretroviral effectiveness is strongest
New approaches to using available agents may provide increased or improved treatment options for AIDS Combination therapy is expected to play a major role in improving survival and quality of life for HIV-infected individuals AZT and ddI are two agents that have been most extensively evaluated and for which the evidence for antiretroviral effectiveness is strongest
Detailed Description:
New approaches to using available agents may provide increased or improved treatment options for AIDS Combination therapy is expected to play a major role in improving survival and quality of life for HIV-infected individuals AZT and ddI are two agents that have been most extensively evaluated and for which the evidence for antiretroviral effectiveness is strongest
Patients take AZT and ddI on an empty stomach ddI is taken 2 minutes after taking antacid Part A patients receive AZT plus ddI each at ranging doses Patients in part B may receive a higher dose of ddI than patients in part A The first patients enrolled are given the lowest dose Subsequent patients receive increasingly higher doses until a dose limiting toxicity occurs
Patients take AZT and ddI on an empty stomach ddI is taken 2 minutes after taking antacid Part A patients receive AZT plus ddI each at ranging doses Patients in part B may receive a higher dose of ddI than patients in part A The first patients enrolled are given the lowest dose Subsequent patients receive increasingly higher doses until a dose limiting toxicity occurs
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 |
|---|---|---|---|
| NCI 91 C-09 | None | None | None |