Laguna Hills, California 92656

  • HIV Infections


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).


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.



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Laguna Hills, California 92656
United States

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Site Status: N/A

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Date Processed: June 13, 2021

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