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

Primary Purpose

Lymphatic Disease, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Inosine pranobex
Sponsored by
Newport Pharmaceuticals International
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphatic Disease focused on measuring T-Lymphocytes, Immune Tolerance, Inosine Pranobex, Killer Cells, T-Lymphocytes, Helper-Inducer, Acquired Immunodeficiency Syndrome, AIDS-Related Complex

Eligibility Criteria

18 Years - 50 Years (Adult)MaleDoes not accept healthy volunteers

Exclusion Criteria Co-existing Condition: Patients with the following are excluded: History of gout, uric acid urolithiasis, uric acid nephrolithiasis, renal dysfunction and severe gastric ulcer. Lymphoid malignancy. Infectious mononucleosis caused by cytomegalovirus or Epstein-Barr virus. Heart disease (especially if receiving cardiac glycosides). Hemophilia. Patients with the following are excluded: Kaposi's sarcoma or overt opportunistic infections as follows: Candida albicans, Pneumocystis carinii, Herpes simplex, Cryptococcus neoformans, Histoplasma capsulatum, Mycobacterium avium-intracellulare, Toxoplasma gondii, Legionella, Cryptosporidium, Isospora, and Papovavirus. Active evidence of infectious mononucleosis caused by Epstein-Barr virus (EBV) or cytomegalovirus (CMV) as determined by heterophil test (EBV) or cell culture (CMV). History of gout, uric acid urolithiasis, uric acid nephrolithiasis, renal dysfunction, and severe gastric ulcer. Critical illness. Condition requiring hospitalization. Women of childbearing age are excluded. Hemophilia. Prior Medication: Excluded: Steroids. Cytotoxic immunosuppressive agents. Antiviral medicine. Prior Treatment: Excluded: Radiotherapy. Patients who have unexplained immunodepression and are at risk of developing AIDS. Patients with prolonged generalized lymphadenopathy for 3 or more months (greater than 1 cm at two or more noncontiguous sites). IV drug abuse.

Sites / Locations

  • Newport Pharmaceuticals International Inc

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Newport Pharmaceuticals International
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1. Study Identification

Unique Protocol Identification Number
NCT00002296
Brief Title
The Safety and Effectiveness of Isoprinosine in Patients With Weakened Immune Systems and Lymph Node Disease
Official Title
A Multi-Center Randomized Double-Blind Placebo-Controlled Study to Investigate the Effect of Isoprinosine in Immunodepressed Patients With Uncomplicated Generalized Lymphadenopathy
Study Type
Interventional

2. Study Status

Record Verification Date
June 1989
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Newport Pharmaceuticals International

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphatic Disease, HIV Infections
Keywords
T-Lymphocytes, Immune Tolerance, Inosine Pranobex, Killer Cells, T-Lymphocytes, Helper-Inducer, Acquired Immunodeficiency Syndrome, AIDS-Related Complex

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
Double

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Inosine pranobex

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Exclusion Criteria Co-existing Condition: Patients with the following are excluded: History of gout, uric acid urolithiasis, uric acid nephrolithiasis, renal dysfunction and severe gastric ulcer. Lymphoid malignancy. Infectious mononucleosis caused by cytomegalovirus or Epstein-Barr virus. Heart disease (especially if receiving cardiac glycosides). Hemophilia. Patients with the following are excluded: Kaposi's sarcoma or overt opportunistic infections as follows: Candida albicans, Pneumocystis carinii, Herpes simplex, Cryptococcus neoformans, Histoplasma capsulatum, Mycobacterium avium-intracellulare, Toxoplasma gondii, Legionella, Cryptosporidium, Isospora, and Papovavirus. Active evidence of infectious mononucleosis caused by Epstein-Barr virus (EBV) or cytomegalovirus (CMV) as determined by heterophil test (EBV) or cell culture (CMV). History of gout, uric acid urolithiasis, uric acid nephrolithiasis, renal dysfunction, and severe gastric ulcer. Critical illness. Condition requiring hospitalization. Women of childbearing age are excluded. Hemophilia. Prior Medication: Excluded: Steroids. Cytotoxic immunosuppressive agents. Antiviral medicine. Prior Treatment: Excluded: Radiotherapy. Patients who have unexplained immunodepression and are at risk of developing AIDS. Patients with prolonged generalized lymphadenopathy for 3 or more months (greater than 1 cm at two or more noncontiguous sites). IV drug abuse.
Facility Information:
Facility Name
Newport Pharmaceuticals International Inc
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92656
Country
United States

12. IPD Sharing Statement

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

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