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


N/A
18 Years
N/A
Not Enrolling
Male
HIV Infections

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Trial Information

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

Inclusion 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.

Type of Study:

Interventional

Study Design:

Masking: Double-Blind, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

008E

NCT ID:

NCT00002059

Start Date:

Completion Date:

Related Keywords:

  • HIV Infections
  • T-Lymphocytes, Suppressor-Effector
  • Neoplasms
  • Inosine Pranobex
  • Killer Cells
  • T-Lymphocytes, Helper-Inducer
  • Acquired Immunodeficiency Syndrome
  • AIDS-Related Complex
  • HIV Infections
  • Acquired Immunodeficiency Syndrome

Name

Location

Newport Pharmaceuticals International IncLaguna Hills, California  92656