Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002214
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
Phase I Trial of S-1153 in Patients With HIV Infection
Sponsor:
Lexigen Pharmaceuticals
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
Phase I Trial of S-1153 in Patients With HIV Infection
Status:
COMPLETED
Status Verified Date:
1998-07
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 toxicity profile and determine the maximum tolerated dose MTD if possible of S-1153 administered orally 3 times daily for 14 days To investigate the clinical pharmacokinetic parameters for S-1153 To assess anti-HIV activity associated with S-1153 administration through evaluation of CD4 and viral load measurements
Detailed Description:
Two separate schedules of S-1153 are administered on this study single dose 2 dose levelscohorts and repeated dose administration over 14 days escalation through 4 dose levelscohorts All doses are determined by body weight
Single-dose study Cohort 1
4 patients low-dose po following a standardized morning meal 4 patients low-dose po fasting
Single-dose study Cohort 2 administered during the first 3 levels of the repeated dose study and prior to the initiation of the 4th repeated dose level
4 patients intermediate-dose po following a standardized morning meal 4 patients intermediate-dose po fasted Following treatment with S-1153 all single-dose patients Cohorts 1and 2 are observed for 21 days
Repeated dose escalation study
All doses are administered for 14 days Three patients are entered at the starting dose of S-1153 In the absence of dose-limiting toxicity DLT subsequent 3-patient cohorts are entered at 3 escalating doses
The last patient at any given dose level must be observed for 21 days prior to entry of patient at the next dose If 1 of the initial 3 patients experiences DLT at a given level 3 additional patients will be added at that dose if no additional toxicity occurs escalation resumes If 2 or more patients at a given dose exhibit DLT the previous dose is declared the maximum tolerated dose MTD and 3 additional patients 6 total are treated at that dose
Single-dose study Cohort 1
4 patients low-dose po following a standardized morning meal 4 patients low-dose po fasting
Single-dose study Cohort 2 administered during the first 3 levels of the repeated dose study and prior to the initiation of the 4th repeated dose level
4 patients intermediate-dose po following a standardized morning meal 4 patients intermediate-dose po fasted Following treatment with S-1153 all single-dose patients Cohorts 1and 2 are observed for 21 days
Repeated dose escalation study
All doses are administered for 14 days Three patients are entered at the starting dose of S-1153 In the absence of dose-limiting toxicity DLT subsequent 3-patient cohorts are entered at 3 escalating doses
The last patient at any given dose level must be observed for 21 days prior to entry of patient at the next dose If 1 of the initial 3 patients experiences DLT at a given level 3 additional patients will be added at that dose if no additional toxicity occurs escalation resumes If 2 or more patients at a given dose exhibit DLT the previous dose is declared the maximum tolerated dose MTD and 3 additional patients 6 total are treated at that dose
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 |
|---|---|---|---|
| 51197 | None | None | None |
| 9616T0311 | None | None | None |