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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Lymphatic Disease, HIV Infections

Intervention / Treatment
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* Drug: Inosine pranobex


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Inosine pranobex|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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T-Lymphocytes, Immune Tolerance, Inosine Pranobex, Killer Cells, T-Lymphocytes, Helper-Inducer, Acquired Immunodeficiency Syndrome, AIDS-Related Complex