HIV Infections
Conditions
Keywords
T-Lymphocytes, Suppressor-Effector, Neoplasms, Inosine Pranobex, Killer Cells, T-Lymphocytes, Helper-Inducer, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
Brief summary
The objective of this double-blind placebo-controlled study is to evaluate the effect of Isoprinosine in a group of homogenous male volunteers who present with immunologic defects relative to: * Comparison of total helper and suppressor T-cell number between the groups. * Comparison of the phytohemagglutinins (PHA) and concanavalin A lymphoproliferative response and natural killer (NK) cell activity between the groups. * Determination of the clinical course of the volunteers after discontinuance of Isoprinosine.
Interventions
DRUGInosine pranobex
Sponsors
Newport Pharmaceuticals International
Study design
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Exclusion criteria
Co-existing Condition: Patients with the following are excluded: * Opportunistic infections or Kaposi's sarcoma. * Critical illness. * History of gout, urolithiasis, nephrolithiasis, renal dysfunction, and severe gastric ulcer. Concurrent Medication: Excluded: * Steroids. * Cytotoxic immunosuppressive agents. Concurrent Treatment: Excluded: * Radiotherapy. The following are excluded: * Opportunistic infections or Kaposi's sarcoma. * Critically ill patients. * Patients receiving steroids, cytotoxic immunosuppressive agents, and/or radiotherapy. * Patients who have received any other immunotherapy. * Patients with a history of gout, urolithiasis, nephrolithiasis, renal dysfunction, and severe gastric ulcer. Prior Medication: Excluded: * Any other immunotherapy. Patients who fall into the group which is at risk of developing cutaneous sarcoma and/or opportunistic diseases but at present have no signs or symptoms of these diseases.
Countries
United States
Outcome results
None listed