A Study of Isoprinosine in Patients With Severe AIDS

This study has been completed.

Sponsor:

Information provided by:

NIH AIDS Clinical Trials Information Service

ClinicalTrials.gov Identifier:

NCT00002295

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 NCT00002295 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 Study of Isoprinosine in Patients With Severe AIDS
Official Title ^ICMJE	A Double-Blind Placebo-Controlled Study to Investigate the Action of Isoprinosine (Inosiplex) in Patients With Severe Acquired Immunodeficiency Syndrome
Brief Summary	To evaluate the effect of Isoprinosine in patients diagnosed as having AIDS relative to: Laboratory (immunologic defects): Comparison of total helper and suppressor T-cell numbers among the groups. Comparison of changes in natural killer cell activity. Comparison of other laboratory findings among the groups. Clinical changes: Comparison of the frequency of opportunistic infections among the groups. Comparison of the frequency of the development of AIDS-related malignancies. Comparison of other clinical manifestations relative to severity and time of onset.
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 Co-existing Condition: Patients with a history of gout, urolithiasis, nephrolithiasis, renal dysfunction, and severe gastric ulcer are excluded. Concurrent Medication: Excluded: Steroids. Cytotoxic immunosuppressive agents. Radiotherapy. The following are excluded: Critically ill patients. Patients receiving steroids, cytotoxic immunosuppressive agents, radiotherapy. Patients who have received any other immunotherapy. Patients with a history of gout, urolithiasis, nephrolithiasis, renal dysfunction, and severe gastric ulcer. Prior Medication: Excluded: Any other immunotherapy. Patients with severe AIDS and specified laboratory immunologic defects.
Gender	Both
Ages	18 Years and older
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	NCT00002295
Other Study ID Numbers ^ICMJE	008F, ISO-141-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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