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

This study has been completed.

Sponsor:

Information provided by:

NIH AIDS Clinical Trials Information Service

ClinicalTrials.gov Identifier:

NCT00002061

First received: November 2, 1999

Last updated: June 23, 2005

Last verified: June 1989

History of Changes

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	June 23, 2005
Start Date ^ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00002061 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Multi-Center Randomized Double-Blind Placebo-Controlled Study To Investigate the Effect of Isoprinosine in Immunodepressed Patients With Uncomplicated Generalized Lymphadenopathy
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 immunologic parameters: Increase in natural killer (NK) cell activity. Increase in total T-cells (OKT-11). Increases in absolute number and percentages of T-helper cells (OKT-4).
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	Lymphatic Disease HIV Infections
Intervention ^ICMJE	Drug: Inosine pranobex
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	Not Provided
Completion Date	Not Provided
Primary Completion Date	Not Provided
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 (CMV) or Epstein-Barr virus (EBV). Heart disease (especially if receiving cardiac glycosides). Hemophilia. Patients with the following are excluded: Kaposi's sarcoma or overt opportunistic infections. Active evidence of infectious mononucleosis caused by Epstein-Barr virus (EBV) or cytomegalovirus (CMV) as determined by heterophile test (EBV) or cell culture (CMV). A 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. Prior Medication: Excluded: Steroids, cytotoxic immunosuppressive agents. Antiviral medicine. Excluded within 1 month of study entry: Immunomodulators (including Isoprinosine). 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 Number ^ICMJE	NCT00002061
Other Study ID Numbers ^ICMJE	008B, ISO-105-USA
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Newport Pharmaceuticals International
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
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

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