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

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 immunologic parameters: Increase in natural killer (NK) cell activity. Increase in total T-cells (OKT-11). Increases in absolute number and percentages 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 (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.

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