HIV Infections
Conditions
Keywords
Infusions, Intravenous, Drug Evaluation, Administration, Oral, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine, Biological Availability
Brief summary
To evaluate the effect of Isoprinosine in patients diagnosed as having AIDS relative to: Laboratory (immunologic defects): * Comparison of total helper and suppressor T-cell numbers among the groups. * Comparison of changes in natural killer cell activity. * Comparison of other laboratory findings among the groups. Clinical changes: * Comparison of the frequency of opportunistic infections among the groups. * Comparison of the frequency of the development of AIDS-related malignancies. * Comparison of other clinical manifestations relative to severity and time of onset.
Interventions
DRUGInosine pranobex
Sponsors
Newport Pharmaceuticals International
Study design
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Exclusion criteria
Co-existing Condition: Patients with a history of gout, urolithiasis, nephrolithiasis, renal dysfunction, and severe gastric ulcer are excluded. Concurrent Medication: Excluded: * Steroids. * Cytotoxic immunosuppressive agents. * Radiotherapy. The following are excluded: * Critically ill patients. * Patients receiving steroids, cytotoxic immunosuppressive agents, 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 with severe AIDS and specified laboratory immunologic defects.
Countries
United States
Outcome results
None listed