The Safety and Effectiveness of Isoprinosine in Patients With Weakened Immune Systems and Lymph Node Disease - Tabular View

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00002296 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	The Safety and Effectiveness of Isoprinosine in Patients With Weakened Immune Systems and Lymph Node Disease
Official Title ^ICMJE	A Multi-Center Randomized Double-Blind Placebo-Controlled Study to Investigate the Effect of Isoprinosine in Immunodepressed Patients With Uncomplicated Generalized Lymphadenopathy
Brief Summary	The objective of this Phase III, randomized, double-blind, placebo-controlled study in patients with immunologic deficiency is to determine the effect of Isoprinosine in producing an immuno-restorative response within the study observation period (including the 2-month period following cessation of the 28 days of treatment), measured by one or more of the following immunological parameters: Increase in natural killer (NK) cell activity. Increase in total T-cells (OKT-11). Increases in absolute number and percentage of T-helper cells (OKT-4).
Detailed Description
Study Phase
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Double-Blind
Condition ^ICMJE	Lymphatic Disease HIV Infections
Intervention ^ICMJE	Drug: Inosine pranobex
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	Exclusion Criteria Co-existing Condition: Patients with the following are excluded: History of gout, uric acid urolithiasis, uric acid nephrolithiasis, renal dysfunction and severe gastric ulcer. Lymphoid malignancy. Infectious mononucleosis caused by cytomegalovirus or Epstein-Barr virus. Heart disease (especially if receiving cardiac glycosides). Hemophilia. Patients with the following are excluded: Kaposi's sarcoma or overt opportunistic infections as follows: Candida albicans, Pneumocystis carinii, Herpes simplex, Cryptococcus neoformans, Histoplasma capsulatum, Mycobacterium avium-intracellulare, Toxoplasma gondii, Legionella, Cryptosporidium, Isospora, and Papovavirus. Active evidence of infectious mononucleosis caused by Epstein-Barr virus (EBV) or cytomegalovirus (CMV) as determined by heterophil test (EBV) or cell culture (CMV). History of gout, uric acid urolithiasis, uric acid nephrolithiasis, renal dysfunction, and severe gastric ulcer. Critical illness. Condition requiring hospitalization. Women of childbearing age are excluded. Hemophilia. Prior Medication: Excluded: Steroids. Cytotoxic immunosuppressive agents. Antiviral medicine. Prior Treatment: Excluded: Radiotherapy. Patients who have unexplained immunodepression and are at risk of developing AIDS. Patients with prolonged generalized lymphadenopathy for 3 or more months (greater than 1 cm at two or more noncontiguous sites). IV drug abuse.
Gender	Male
Ages	18 Years to 50 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00002296
Responsible Party
Study ID Numbers ^ICMJE	008C, ISO-106-USA
Study Sponsor ^ICMJE	Newport Pharmaceuticals International
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	June 1989
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP