A Study of Isoprinosine in Patients With Severe AIDS

This study has been completed.

Sponsored by:	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):

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

MedlinePlus related topics: AIDS

Drug Information available for: Zidovudine Inosine 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

Eligibility

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:

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:

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

Study ID Numbers:	008F, ISO-141-USA
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002295
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

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome

Zidovudine
AIDS-Related Complex
Inosine Pranobex
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Anti-Infective Agents
RNA Virus Infections
Slow Virus Diseases
Immunologic Factors
Immune System Diseases
Therapeutic Uses

Physiological Effects of Drugs
Adjuvants, Immunologic
Lentivirus Infections
Infection
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009