A Double-Blind Placebo Controlled Study To Determine the Optimal Immunopharmacological Dose Level of Isoprinosine in Immunodepressed Volunteers
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ClinicalTrials.gov Identifier: NCT00002059 |
Recruitment Status
:
Completed
First Posted
: August 31, 2001
Last Update Posted
: June 24, 2005
|
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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 or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: Inosine pranobex | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | A Double-Blind Placebo Controlled Study To Determine the Optimal Immunopharmacological Dose Level of Isoprinosine in Immunodepressed Volunteers |


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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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.

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): NCT00002059
United States, California | |
Newport Pharmaceuticals International Inc | |
Laguna Hills, California, United States, 92656 |
ClinicalTrials.gov Identifier: | NCT00002059 History of Changes |
Other Study ID Numbers: |
008E ISO-133-USA |
First Posted: | August 31, 2001 Key Record Dates |
Last Update Posted: | June 24, 2005 |
Last Verified: | June 1989 |
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 Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes |
Immune System Diseases Inosine Pranobex Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Antiviral Agents Anti-Infective Agents |