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A Multi-Center Randomized Double-Blind Placebo-Controlled Study To Investigate the Effect of Isoprinosine in Immunodepressed Patients With Uncomplicated Generalized Lymphadenopathy Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on A Multi-Center Randomized Double-Blind Placebo-Controlled Study To Investigate the Effect of Isoprinosine in Immunodepressed Patients With Uncomplicated Generalized Lymphadenopathy conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. A Multi-Center Randomized Double-Blind Placebo-Controlled Study To Investigate the Effect of Isoprinosine in Immunodepressed Patients With Uncomplicated Generalized Lymphadenopathy Clinical research trials and A Multi-Center Randomized Double-Blind Placebo-Controlled Study To Investigate the Effect of Isoprinosine in Immunodepressed Patients With Uncomplicated Generalized Lymphadenopathy healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as A Multi-Center Randomized Double-Blind Placebo-Controlled Study To Investigate the Effect of Isoprinosine in Immunodepressed Patients With Uncomplicated Generalized Lymphadenopathy. A Multi-Center Randomized Double-Blind Placebo-Controlled Study To Investigate the Effect of Isoprinosine in Immunodepressed Patients With Uncomplicated Generalized Lymphadenopathy Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a A Multi-Center Randomized Double-Blind Placebo-Controlled Study To Investigate the Effect of Isoprinosine in Immunodepressed Patients With Uncomplicated Generalized Lymphadenopathy clinical trial. Human subjects often receive the most effective healthcare possible for their A Multi-Center Randomized Double-Blind Placebo-Controlled Study To Investigate the Effect of Isoprinosine in Immunodepressed Patients With Uncomplicated Generalized Lymphadenopathy condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.

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A Multi-Center Randomized Double-Blind Placebo-Controlled Study To Investigate the Effect of Isoprinosine in Immunodepressed Patients With Uncomplicated Generalized Lymphadenopathy



A Multi-Center Randomized Double-Blind Placebo-Controlled Study To Investigate the Effect of Isoprinosine in Immunodepressed Patients With Uncomplicated Generalized Lymphadenopathy

For Condition: Lymphatic Disease,HIV Infections
Status: Completed
Sponsor(s): Newport Pharmaceuticals International ,
Synopsis: 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 immunologic parameters: o Increase in natural killer (NK) cell activity. o Increase in total T-cells (OKT-11). o Increases in absolute number and percentages of T-helper cells (OKT-4).
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Double-Blind
Minimum Age/Maximum Age: 18 Years/50 Years
Genders: Male
Protocol Entry 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 (CMV) or Epstein-Barr virus (EBV). - Heart disease (especially if receiving cardiac glycosides). - Hemophilia. Patients with the following are excluded: - Kaposi's sarcoma or overt opportunistic infections. - Active evidence of infectious mononucleosis caused by Epstein-Barr virus (EBV) or cytomegalovirus (CMV) as determined by heterophile test (EBV) or cell culture (CMV). - A 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. Prior Medication: Excluded: - Steroids, cytotoxic immunosuppressive agents. - Antiviral medicine. - Excluded within 1 month of study entry: - Immunomodulators (including Isoprinosine). 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.
Total Enrollment: 

Location and Contact Information:

Newport Pharmaceuticals International Inc
Laguna Hills,  California,  92656
United States
 


Additional Information:
Study ID Numbers:
  008B;  ISO-105-USA
Study Start Date: 
Record last reviewed: June 1989
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002061

Other Lymphatic Disease Studies:
1. The Safety and Effectiveness of Isoprinosine in Patients with Weakened Immune Systems and Lymph Node Disease

2. A Study of Isoprinosine in Patients with Lymph Node Disease

3. A Multi-Center Randomized Double-Blind Placebo-Controlled Study To Investigate the Effect of Isoprinosine in Immunodepressed Patients With Uncomplicated Generalized Lymphadenopathy

4. Study of Autoimmune Lymphoproliferative Syndrome (ALPS)

5. Pyrimethamine to Treat Autoimmune Lymphoproliferative Syndrome

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A Multi-Center Randomized Double-Blind Placebo-Controlled Study To Investigate the Effect of Isoprinosine in Immunodepressed Patients With Uncomplicated Generalized Lymphadenopathy

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