A Study of Isoprinosine in Patients With Severe AIDS - Full Text View

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):

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

MedlinePlus related topics:

AIDS

Drug Information available for:

Zidovudine Inosine Inosine pranobex

U.S. FDA Resources

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

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

Study ID Numbers:	008F, ISO-141-USA
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 December 03, 2008