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

Purpose

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.

Condition	Intervention
HIV Infections	Drug: Inosine pranobex


Study Type:	Interventional
Study Design:	Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Multi-Center Randomized Double-Blind Placebo-Controlled Study To Investigate the Effect of Isoprinosine in Patients With AIDS Related Complex (ARC)

Resource links provided by NLM:

MedlinePlus related topics: Gay, Lesbian, Bisexual and Transgender Health HIV/AIDS

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Eligibility


Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002060

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


ClinicalTrials.gov Identifier:	NCT00002060 History of Changes
Other Study ID Numbers:	008D, ISO-111-USA
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:


AIDS-Related Opportunistic Infections Inosine Pranobex Homosexuality Acquired Immunodeficiency Syndrome AIDS-Related Complex

Additional relevant MeSH terms:


AIDS-Related Complex HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases	Virus Diseases Inosine Pranobex Adjuvants, Immunologic Anti-Infective Agents Antiviral Agents Immunologic Factors Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015

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