Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000645
Status:
COMPLETED
Last Update Posted:
2021-11-03
First Post:
1999-11-02
Brief Title:
A Phase I Dose Escalation Study of Synthetic Hypericin in HIV-Infected Patients With Less Than 300 CD4 Lymphocytes
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 Dose Escalation Study of Synthetic Hypericin in HIV-Infected Patients With Less Than 300 CD4 Lymphocytes
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 maximum tolerated dose MTD of hypericin to define the types of toxicities that may be observed and to determine what doses of the drug are associated with improvements in virological and immunological surrogate markers of HIV infection To determine the bioavailability of synthetic hypericin given in 2 percent benzyl alcohol solution
Hypericin is unlike other drugs presently being used to treat AIDS patients Hypericin shows anti-HIV activity in test tube experiments
Hypericin is unlike other drugs presently being used to treat AIDS patients Hypericin shows anti-HIV activity in test tube experiments
Detailed Description:
Hypericin is unlike other drugs presently being used to treat AIDS patients Hypericin shows anti-HIV activity in test tube experiments
Each group of eight patients receives a given dose of hypericin by intravenous infusion Doses are given three times per week for 8 weeks When all eight patients at a dose level have been entered and four of the eight patients have completed 3 weeks of therapy without evidence of dose-limiting toxicity additional patients may begin to receive drug at the next dose level Concurrently six patients wll participate in an oral-dosing bioavailability study NOTE The initial study was stopped secondary to an MTD being reached
Each group of eight patients receives a given dose of hypericin by intravenous infusion Doses are given three times per week for 8 weeks When all eight patients at a dose level have been entered and four of the eight patients have completed 3 weeks of therapy without evidence of dose-limiting toxicity additional patients may begin to receive drug at the next dose level Concurrently six patients wll participate in an oral-dosing bioavailability study NOTE The initial study was stopped secondary to an MTD being reached
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 |
|---|---|---|---|
| 11125 | REGISTRY | DAIDS ES Registry Number | None |