Expired Study
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Laguna Hills, California 92656


Purpose:

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).


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.


NCT ID:

NCT00002296


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Laguna Hills, California 92656
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 24, 2017

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