Back to resultsA Study of Isoprinosine in Patients With Lymph Node Disease
Primary Purpose
Lymphatic Disease, HIV Infections
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Inosine pranobex
Sponsored by
About this trial
This is an interventional treatment trial for Lymphatic Disease focused on measuring Inosine Pranobex, AIDS-Related Complex
Eligibility 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).
Sites / Locations
- Newport Pharmaceuticals International Inc
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00002297
First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Newport Pharmaceuticals International
1. Study Identification
Unique Protocol Identification Number
NCT00002297
Brief Title
A Study of Isoprinosine in Patients With Lymph Node Disease
Official Title
A Multi-Center Double-Blind Placebo-Controlled Study to Investigate the Action of Isoprinosine (Inosiplex) in Patients With Unexplained Generalized Lymphadenopathy
Study Type
Interventional
2. Study Status
Record Verification Date
June 1989
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Newport Pharmaceuticals International
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphatic Disease, HIV Infections
Keywords
Inosine Pranobex, AIDS-Related Complex
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
Double
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Inosine pranobex
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Facility Information:
Facility Name
Newport Pharmaceuticals International Inc
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92656
Country
United States
12. IPD Sharing Statement
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A Study of Isoprinosine in Patients With Lymph Node Disease
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