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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002060
First Posted: August 31, 2001
Last Update Posted: June 24, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
NIH AIDS Clinical Trials Information Service
  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
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:


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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002060


Locations
United States, California
Newport Pharmaceuticals International Inc
Laguna Hills, California, United States, 92656
Sponsors and Collaborators
Newport Pharmaceuticals International
  More Information

ClinicalTrials.gov Identifier: NCT00002060     History of Changes
Other Study ID Numbers: 008D
ISO-111-USA
First Submitted: November 2, 1999
First Posted: August 31, 2001
Last Update Posted: June 24, 2005
Last Verified: June 1989

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