A Study of Isoprinosine in Patients With Severe AIDS

This study has been completed.

First Received: November 2, 1999 Last Updated: June 23, 2005 History of Changes

Sponsor:	Newport Pharmaceuticals International
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002295

Purpose

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.

Condition	Intervention
HIV Infections	Drug: Inosine pranobex

Study Type:	Interventional
Study Design:	Treatment, Double-Blind
Official Title:	A Double-Blind Placebo-Controlled Study to Investigate the Action of Isoprinosine (Inosiplex) in Patients With Severe Acquired Immunodeficiency Syndrome

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Inosine Inosine pranobex

U.S. FDA Resources

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002295

Locations

United States, California
Newport Pharmaceuticals International Inc
Laguna Hills, California, United States, 92656

Sponsors and Collaborators

Newport Pharmaceuticals International

More Information

No publications provided

Study ID Numbers:	008F, ISO-141-USA
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002295 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

Infusions, Intravenous
Drug Evaluation
Administration, Oral
Acquired Immunodeficiency Syndrome

AIDS-Related Complex
Zidovudine
Biological Availability

Additional relevant MeSH terms:

Anti-Infective Agents
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Acquired Immunodeficiency Syndrome
Adjuvants, Immunologic
Infection

Inosine Pranobex
Antiviral Agents
Pharmacologic Actions
Immunologic Deficiency Syndromes
Virus Diseases
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on November 09, 2009