Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000792
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
A Pharmacologically Guided Phase III Study of Daily Orally Administered Synthetic Hypericin in HIV-Infected Subjects
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Pharmacologically Guided Phase III Study of Daily Orally Administered Synthetic Hypericin in HIV-Infected Subjects
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 determine the safety and tolerance of daily oral hypericin when given to achieve target trough levels within defined cohorts To determine the responses of surrogate markers of HIV infection to daily oral hypericin
It is not known whether daily oral dosing will produce a tolerable prolonged exposure to therapeutic levels of hypericin Pharmacokinetic modeling studies have demonstrated that daily oral dosing should produce a trough level in a desired range without excessive peak levels
It is not known whether daily oral dosing will produce a tolerable prolonged exposure to therapeutic levels of hypericin Pharmacokinetic modeling studies have demonstrated that daily oral dosing should produce a trough level in a desired range without excessive peak levels
Detailed Description:
It is not known whether daily oral dosing will produce a tolerable prolonged exposure to therapeutic levels of hypericin Pharmacokinetic modeling studies have demonstrated that daily oral dosing should produce a trough level in a desired range without excessive peak levels
Cohorts of six patients each receive escalating doses of oral hypericin daily Blood is sampled for peak and trough levels the second week of therapy A computer modeling algorithm will use these levels to determine the appropriate dose needed for each patient to achieve the desired trough level When three of six patients at a given dose have completed 3 weeks of therapy without evidence of dose-limiting toxicity data will be reviewed to determine whether subsequent patients should be entered at the next higher dose The MTD is defined as the dose level immediately below that at which grade 3 or worse toxicity is seen in three or more of six patients
Cohorts of six patients each receive escalating doses of oral hypericin daily Blood is sampled for peak and trough levels the second week of therapy A computer modeling algorithm will use these levels to determine the appropriate dose needed for each patient to achieve the desired trough level When three of six patients at a given dose have completed 3 weeks of therapy without evidence of dose-limiting toxicity data will be reviewed to determine whether subsequent patients should be entered at the next higher dose The MTD is defined as the dose level immediately below that at which grade 3 or worse toxicity is seen in three or more of six patients
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 |
|---|---|---|---|
| 11235 | REGISTRY | DAIDS ES Registry Number | None |