HIV Infections, Lymphatic Disease
Conditions
Keywords
Inosine Pranobex, AIDS-Related Complex
Brief summary
The objectives of this study are to determine the effects of isoprinosine in patients diagnosed as having unexplained generalized lymphadenopathy. Variables to be examined will include: Signs and symptoms: * Lymphadenopathy. * Fever. * Weight loss. * Occurrence of opportunistic infections. Cell-mediated immune system parameters: * T-helper cell (OKT4) numbers and proportions. * T-suppressor cell (OKT8) numbers and proportions. * Natural killer (NK) cell activity. * Lymphocyte blastogenic response to phytohemagglutinin (PHA). * Lymphocyte blastogenic response to pokeweed mitogen (PWM). * Immunoglobulin (IgG, IgA, IgM, IgE, IgD) profile. * Circulating immune complexes. Infections characteristically associated with AIDS, such as Candida albicans, Pneumocystis carinii pneumonia, Cytomegalovirus, Herpes simplex, Cryptococcus, Histoplasma, Toxoplasma, Cryptosporidium, Mycobacterium avium- intracellulare, Legionella, and Isospora. Safety parameters: * Blood chemistry including serum uric acid (PurposeA-12). * Complete blood count (CBC). * Platelet count.
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 a history of gout, uric acid urolithiasis, uric acid nephrolithiasis, renal dysfunction, or gastric ulceration are excluded. Concurrent Medication: Excluded: * Systemic corticosteroids. * Cytotoxic immunosuppressive agents. * Radiotherapy. Critically ill patients or those with CDC-defined AIDS are excluded. Prior Medication: Excluded within 1 month of study entry: * Immunotherapy. Patients with persistent generalized lymphadenopathy (PGL).
Countries
United States
Outcome results
None listed