The Safety and Effectiveness of Isoprinosine in Patients With Weakened Immune Systems and Lymph Node Disease

Not Applicable

Completed

• Conditions: Lymphatic Disease; HIV Infections

• Registration Number: NCT00002296
• Lead Sponsor: Newport Pharmaceuticals International

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

Not available

Study Timeline

• Status Verified: 1989-06
• Study First Submitted: 1999-11-02
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Last Update Submitted: 2005-06-23
• Last Update Posted: 2005-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Newport Pharmaceuticals International Inc; 🇺🇸 Laguna Hills, California, United States