A Study of Isoprinosine in Patients With Lymph Node Disease
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:
- 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.
- Blood chemistry including serum uric acid (PurposeA-12).
- Complete blood count (CBC).
- Platelet count.
|Study Design:||Masking: Double
Primary Purpose: Treatment
|Official Title:||A Multi-Center Double-Blind Placebo-Controlled Study to Investigate the Action of Isoprinosine (Inosiplex) in Patients With Unexplained Generalized Lymphadenopathy|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002297
|United States, California|
|Newport Pharmaceuticals International Inc|
|Laguna Hills, California, United States, 92656|