Viewing Study NCT00002296



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Last Modification Date: 2024-10-26 @ 9:02 AM
Study NCT ID: NCT00002296
Status: COMPLETED
Last Update Posted: 2005-06-24
First Post: 1999-11-02

Brief Title: The Safety and Effectiveness of Isoprinosine in Patients With Weakened Immune Systems and Lymph Node Disease
Sponsor: Newport Pharmaceuticals International
Organization: NIH AIDS Clinical Trials Information Service

Study Overview

Official Title: A Multi-Center Randomized Double-Blind Placebo-Controlled Study to Investigate the Effect of Isoprinosine in Immunodepressed Patients With Uncomplicated Generalized Lymphadenopathy
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: The objective of this Phase III randomized double-blind placebo-controlled study in patients with immunologic deficiency is to determine the effect of Isoprinosine in producing an immuno-restorative response within the study observation period including the 2-month period following cessation of the 28 days of treatment measured by one or more of the following immunological parameters

Increase in natural killer NK cell activity
Increase in total T-cells OKT-11
Increases in absolute number and percentage of T-helper cells OKT-4
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 IDs
Secondary ID Type Domain Link
ISO-106-USA None None None