A Study of Isoprinosine in Patients With Severe AIDS

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002295
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: June 1989
  Purpose

To evaluate the effect of Isoprinosine in patients diagnosed as having AIDS relative to:

Laboratory (immunologic defects):

  • Comparison of total helper and suppressor T-cell numbers among the groups.
  • Comparison of changes in natural killer cell activity.
  • Comparison of other laboratory findings among the groups.

Clinical changes:

  • Comparison of the frequency of opportunistic infections among the groups.
  • Comparison of the frequency of the development of AIDS-related malignancies.
  • Comparison of other clinical manifestations relative to severity and time of onset.

Condition Intervention
HIV Infections
Drug: Inosine pranobex

Study Type: Interventional
Study Design: Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Double-Blind Placebo-Controlled Study to Investigate the Action of Isoprinosine (Inosiplex) in Patients With Severe Acquired Immunodeficiency Syndrome

Resource links provided by NLM:


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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Exclusion Criteria

Co-existing Condition:

Patients with a history of gout, urolithiasis, nephrolithiasis, renal dysfunction, and severe gastric ulcer are excluded.

Concurrent Medication:

Excluded:

  • Steroids.
  • Cytotoxic immunosuppressive agents.
  • Radiotherapy.

The following are excluded:

  • Critically ill patients.
  • Patients receiving steroids, cytotoxic immunosuppressive agents, radiotherapy.
  • Patients who have received any other immunotherapy.
  • Patients with a history of gout, urolithiasis, nephrolithiasis, renal dysfunction, and severe gastric ulcer.

Prior Medication:

Excluded:

  • Any other immunotherapy.

Patients with severe AIDS and specified laboratory immunologic defects.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002295

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: NCT00002295     History of Changes
Other Study ID Numbers: 008F, ISO-141-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:
Infusions, Intravenous
Drug Evaluation
Administration, Oral
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Zidovudine
Biological Availability

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases
Inosine Pranobex
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014