Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2025-12-27 @ 11:19 PM
Study NCT ID:
NCT00002295
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Isoprinosine in Patients With Severe AIDS
Sponsor:
Newport Pharmaceuticals International
Organization:
Study Overview
Official Title:
A Double-Blind Placebo-Controlled Study to Investigate the Action of Isoprinosine (Inosiplex) in Patients With Severe Acquired Immunodeficiency Syndrome
Status:
COMPLETED
Status Verified Date:
1989-06
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 evaluate the effect of Isoprinosine in patients diagnosed as having AIDS relative to:
Laboratory (immunologic defects):
* Comparison of total helper and suppressor T-cell numbers among the groups.
* Comparison of changes in natural killer cell activity.
* Comparison of other laboratory findings among the groups.
Clinical changes:
* Comparison of the frequency of opportunistic infections among the groups.
* Comparison of the frequency of the development of AIDS-related malignancies.
* Comparison of other clinical manifestations relative to severity and time of onset.
Laboratory (immunologic defects):
* Comparison of total helper and suppressor T-cell numbers among the groups.
* Comparison of changes in natural killer cell activity.
* Comparison of other laboratory findings among the groups.
Clinical changes:
* Comparison of the frequency of opportunistic infections among the groups.
* Comparison of the frequency of the development of AIDS-related malignancies.
* Comparison of other clinical manifestations relative to severity and time of onset.
Detailed Description:
None
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 ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| ISO-141-USA | None | None | View |