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.

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

Sponsored by:	Newport Pharmaceuticals International
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002060

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:	Treatment, Double-Blind
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: AIDS Gay, Lesbian and Transgender Health

Drug Information available for: Inosine Inosine pranobex

U.S. FDA Resources

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

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

Study ID Numbers:	008D, ISO-111-USA
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002060 History of Changes
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

Study placed in the following topic categories:

Opportunistic Infections
Sexually Transmitted Diseases, Viral
Immunologic Factors
Acquired Immunodeficiency Syndrome
Adjuvants, Immunologic
AIDS-Related Complex
Inosine Pranobex

Antiviral Agents
Immunologic Deficiency Syndromes
Virus Diseases
HIV Infections
AIDS-Related Opportunistic Infections
Sexually Transmitted Diseases
Retroviridae Infections

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
AIDS-Related Complex
Inosine Pranobex

Infection
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 July 02, 2009