A Multi-Center Randomized Double-Blind Placebo-Controlled Study To Investigate the Effect of Isoprinosine in Patients With AIDS Related Complex (ARC)

This study has been completed.

Sponsor:

Information provided by:

NIH AIDS Clinical Trials Information Service

ClinicalTrials.gov Identifier:

NCT00002060

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 NCT00002060 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 Patients With AIDS Related Complex (ARC)
Official Title ^ICMJE	A Multi-Center Randomized Double-Blind Placebo-Controlled Study To Investigate the Effect of Isoprinosine in Patients With AIDS Related Complex (ARC)
Brief Summary	The objective is to determine the effect of Isoprinosine (inosine pranobex) in homosexual male patients with AIDS related complex (ARC) in delaying the onset of AIDS. Secondly, to determine the effect of Isoprinosine in decreasing the severity and/or incidence of lesser opportunistic infections and/or other conditions associated with ARC.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	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 Concurrent Medication: Excluded: Cardiac glycosides. Patients with the following are excluded: AIDS. Presenting with chronic candida infection-colo/rectal, oral/pharyngeal, cutaneous (finger/toenails) - for = or > 3 months who have not responded to therapy. Critical illness. Hemophilia. Prior Medication: Excluded within 1 month of study entry: Steroids. Cytotoxic immunosuppressive agents. Radiotherapy and/or systemic antiviral medication. Immunomodulators (including Isoprinosine). Prior Treatment: Excluded within 1 month of study entry: Radiotherapy. History of gout, uric acid urolithiasis, uric acid nephrolithiasis, or renal dysfunction. Lymphoid malignancy. Homosexual male patients with AIDS related complex (ARC). Current IV drug abuse.
Gender	Male
Ages	18 Years to 75 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	NCT00002060
Other Study ID Numbers ^ICMJE	008D, ISO-111-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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