Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  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:


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
Acquired Immunodeficiency Syndrome
HIV Infections
Infection
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 November 25, 2014