HIV Infections Clinical Trial
Official title:
A Multi-Center Double-Blind Placebo-Controlled Study to Investigate the Action of Isoprinosine (Inosiplex) in Patients With Unexplained Generalized Lymphadenopathy
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.
n/a
Masking: Double-Blind, Primary Purpose: Treatment
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