A Study of Isoprinosine in Patients With Lymph Node Disease
NCT00002297 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL
Last updated 2005-06-24
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.
Conditions
- Lymphatic Disease
- HIV Infections
Interventions
- DRUG
-
Inosine pranobex
Sponsors & Collaborators
-
Newport Pharmaceuticals International
lead INDUSTRY
Study Design
- Purpose
- TREATMENT
- Masking
- DOUBLE
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
Countries
- United States
Study Locations
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