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A Study of Isoprinosine in Patients with Lymph Node Disease



A Study of Isoprinosine in Patients with Lymph Node Disease

For Condition: Lymphatic Disease,HIV Infections
Status: Completed
Sponsor(s): Newport Pharmaceuticals International ,
Synopsis: 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: o Lymphadenopathy. o Fever. o Weight loss. o Occurrence of opportunistic infections. Cell-mediated immune system parameters: o T-helper cell (OKT4) numbers and proportions. o T-suppressor cell (OKT8) numbers and proportions. o Natural killer (NK) cell activity. o Lymphocyte blastogenic response to phytohemagglutinin (PHA). o Lymphocyte blastogenic response to pokeweed mitogen (PWM). o Immunoglobulin (IgG, IgA, IgM, IgE, IgD) profile. o 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: o Blood chemistry including serum uric acid (PurposeA-12). o Complete blood count (CBC). o Platelet count.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Double-Blind
Minimum Age/Maximum Age: 18 Years/
Genders: Male
Protocol Entry Criteria: 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).
Total Enrollment: 

Location and Contact Information:

Newport Pharmaceuticals International Inc
Laguna Hills,  California,  92656
United States
 


Additional Information:
Study ID Numbers:
  008A;  ISO-103-USA
Study Start Date: 
Record last reviewed: June 1989
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002297

Other Hiv Infections Studies:
1. Study of Autoimmune Lymphoproliferative Syndrome (ALPS)

2. The Safety and Effectiveness of Isoprinosine in Patients with Weakened Immune Systems and Lymph Node Disease

3. A Multi-Center Randomized Double-Blind Placebo-Controlled Study To Investigate the Effect of Isoprinosine in Immunodepressed Patients With Uncomplicated Generalized Lymphadenopathy

4. Pyrimethamine to Treat Autoimmune Lymphoproliferative Syndrome

5. A Study of Isoprinosine in Patients with Lymph Node Disease

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