- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002296
The Safety and Effectiveness of Isoprinosine in Patients With Weakened Immune Systems and Lymph Node Disease
A Multi-Center Randomized Double-Blind Placebo-Controlled Study to Investigate the Effect of Isoprinosine in Immunodepressed Patients With Uncomplicated Generalized Lymphadenopathy
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).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Laguna Hills, California, United States, 92656
- Newport Pharmaceuticals International Inc
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: Double
Collaborators and Investigators
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 008C
- ISO-106-USA
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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