HIV Infections, Lymphatic Disease
Conditions
Keywords
T-Lymphocytes, Immune Tolerance, Inosine Pranobex, Killer Cells, T-Lymphocytes, Helper-Inducer, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
Brief summary
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).
Interventions
DRUGInosine pranobex
Sponsors
Newport Pharmaceuticals International
Study design
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
No
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.
Countries
United States
Outcome results
None listed