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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.

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

MedlinePlus related topics:   AIDS    Gay, Lesbian and Transgender Health   

Drug Information available for:   Inosine    Inosine pranobex   

U.S. FDA Resources

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)
  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


Study ID Numbers:   008D, ISO-111-USA
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002060
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:
Virus Diseases
Opportunistic Infections
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
AIDS-Related Opportunistic Infections
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




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