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

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002295 on ClinicalTrials.gov Archive Site
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A Study of Isoprinosine in Patients With Severe AIDS
A Double-Blind Placebo-Controlled Study to Investigate the Action of Isoprinosine (Inosiplex) in Patients With Severe Acquired Immunodeficiency Syndrome

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.
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Interventional
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Masking: Double-Blind
Primary Purpose: Treatment
HIV Infections
Drug: Inosine pranobex
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002295
008F, ISO-141-USA
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Newport Pharmaceuticals International
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NIH AIDS Clinical Trials Information Service
June 1989

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP