A Double-Blind Placebo Controlled Study To Determine the Optimal Immunopharmacological Dose Level of Isoprinosine in Immunodepressed Volunteers
This study has been completed.
Sponsor:
Newport Pharmaceuticals International
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002059
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: June 1989
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The objective of this double-blind placebo-controlled study is to evaluate the effect of Isoprinosine in a group of homogenous male volunteers who present with immunologic defects relative to:
- Comparison of total helper and suppressor T-cell number between the groups.
- Comparison of the phytohemagglutinins (PHA) and concanavalin A lymphoproliferative response and natural killer (NK) cell activity between the groups.
- Determination of the clinical course of the volunteers after discontinuance of Isoprinosine.
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 Determine the Optimal Immunopharmacological Dose Level of Isoprinosine in Immunodepressed Volunteers |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
Further study details as provided by NIH AIDS Clinical Trials Information Service:
![](https://webarchive.library.unt.edu/web/20130228141257im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Criteria
Exclusion Criteria
Co-existing Condition:
Patients with the following are excluded:
- Opportunistic infections or Kaposi's sarcoma.
- Critical illness.
- History of gout, urolithiasis, nephrolithiasis, renal dysfunction, and severe gastric ulcer.
Concurrent Medication:
Excluded:
- Steroids.
- Cytotoxic immunosuppressive agents.
Concurrent Treatment:
Excluded:
- Radiotherapy.
The following are excluded:
- Opportunistic infections or Kaposi's sarcoma.
- Critically ill patients.
- Patients receiving steroids, cytotoxic immunosuppressive agents, and/or 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 who fall into the group which is at risk of developing cutaneous sarcoma and/or opportunistic diseases but at present have no signs or symptoms of these diseases.
![](https://webarchive.library.unt.edu/web/20130228141257im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
![](https://webarchive.library.unt.edu/web/20130228141257im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
No publications provided
ClinicalTrials.gov Identifier: | NCT00002059 History of Changes |
Other Study ID Numbers: | 008E, ISO-133-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:
T-Lymphocytes, Suppressor-Effector Neoplasms Inosine Pranobex Killer Cells |
T-Lymphocytes, Helper-Inducer Acquired Immunodeficiency Syndrome AIDS-Related Complex |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome 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 Pharmacologic Actions Antiviral Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on February 26, 2013