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A Double-Blind Placebo Controlled Study To Determine the Optimal Immunopharmacological Dose Level of Isoprinosine in Immunodepressed Volunteers



A Double-Blind Placebo Controlled Study To Determine the Optimal Immunopharmacological Dose Level of Isoprinosine in Immunodepressed Volunteers

For Condition: HIV Infections
Status: Completed
Sponsor(s): Newport Pharmaceuticals International ,
Synopsis: 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: o Comparison of total helper and suppressor T-cell number between the groups. o Comparison of the phytohemagglutinins (PHA) and concanavalin A lymphoproliferative response and natural killer (NK) cell activity between the groups. o Determination of the clinical course of the volunteers after discontinuance of Isoprinosine.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Double-Blind
Minimum Age/Maximum Age: 18 Years/
Genders: Male
Protocol Entry 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.
Total Enrollment: 

Location and Contact Information:

Newport Pharmaceuticals International Inc
Laguna Hills,  California,  92656
United States
 


Additional Information:
Study ID Numbers:
  008E;  ISO-133-USA
Study Start Date: 
Record last reviewed: June 1989
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002059

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