Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000669
Status:
COMPLETED
Last Update Posted:
2008-08-26
First Post:
1999-11-02
Brief Title:
A Phase I Safety and Pharmacokinetics Study of 23-Dideoxyinosine ddI Administered Twice Daily to Infants and Children With AIDS or Symptomatic HIV Infection
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 and Pharmacokinetics Study of 23-Dideoxyinosine ddI Administered Twice Daily to Infants and Children With AIDS or Symptomatic HIV Infection
Status:
COMPLETED
Status Verified Date:
1996-10
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 and maximum tolerated dose MTD of 23-dideoxyinosine ddI given orally and intravenously in infants and children with AIDS The study also measures bloodstream and cerebrospinal fluid CSF levels of the administered drug and provides a preliminary assessment of the effectiveness of ddI on HIV replication
AMENDED Based on safety established in the first dosing phase of 52 weeks and long term dosing data in adults the dosing period will be extended to 104 weeks Original design Information presently available indicates that ddI has high antiviral activity with less apparent toxicity than zidovudine AZT the drug presently used to treat AIDS
AMENDED Based on safety established in the first dosing phase of 52 weeks and long term dosing data in adults the dosing period will be extended to 104 weeks Original design Information presently available indicates that ddI has high antiviral activity with less apparent toxicity than zidovudine AZT the drug presently used to treat AIDS
Detailed Description:
AMENDED Based on safety established in the first dosing phase of 52 weeks and long term dosing data in adults the dosing period will be extended to 104 weeks Original design Information presently available indicates that ddI has high antiviral activity with less apparent toxicity than zidovudine AZT the drug presently used to treat AIDS
AMENDED Dosing will proceed for 104 weeks at each dose level Original design Five patients are treated at the initial dose level Because ddI is not stable in the acid environment of the stomach oral doses of ddI follow administration of an antacid An alternative method of dosing is to mix the reconstituted ddI with an appropriate volume of Maalox TC or Mylanta II In order to determine the MTD successive groups of 5 patients enter the study at a higher dose level after 3 patients have experienced 3 weeks of dosing and significant toxicities have not developed Patients are assigned to treatment groups in the order in which they are enrolled Dosing proceeds for 16 weeks at each dose level However consideration is given to escalating patients entered at the lowest dose to the next dose level after 10 weeks of dosing The dose escalation continues until toxicities requiring dose modifications are found in 2 of 5 in any group
AMENDED Dosing will proceed for 104 weeks at each dose level Original design Five patients are treated at the initial dose level Because ddI is not stable in the acid environment of the stomach oral doses of ddI follow administration of an antacid An alternative method of dosing is to mix the reconstituted ddI with an appropriate volume of Maalox TC or Mylanta II In order to determine the MTD successive groups of 5 patients enter the study at a higher dose level after 3 patients have experienced 3 weeks of dosing and significant toxicities have not developed Patients are assigned to treatment groups in the order in which they are enrolled Dosing proceeds for 16 weeks at each dose level However consideration is given to escalating patients entered at the lowest dose to the next dose level after 10 weeks of dosing The dose escalation continues until toxicities requiring dose modifications are found in 2 of 5 in any group
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 |
|---|---|---|---|
| AI454-003 | None | None | None |
| 070V1 | None | None | None |