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Sponsored by: |
Newport Pharmaceuticals International |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002296 |
The objective of this Phase III, randomized, double-blind, placebo-controlled study in patients with immunologic deficiency is to determine the effect of Isoprinosine in producing an immuno-restorative response within the study observation period (including the 2-month period following cessation of the 28 days of treatment), measured by one or more of the following immunological parameters:
Condition | Intervention |
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Lymphatic Disease HIV Infections |
Drug: Inosine pranobex |
Study Type: | Interventional |
Study Design: | Treatment, Double-Blind |
Official Title: | A Multi-Center Randomized Double-Blind Placebo-Controlled Study to Investigate the Effect of Isoprinosine in Immunodepressed Patients With Uncomplicated Generalized Lymphadenopathy |
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Exclusion Criteria
Co-existing Condition:
Patients with the following are excluded:
Patients with the following are excluded:
Prior Medication:
Excluded:
Prior Treatment:
Excluded:
Patients who have unexplained immunodepression and are at risk of developing AIDS.
IV drug abuse.
Study ID Numbers: | 008C, ISO-106-USA |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002296 |
Health Authority: | United States: Food and Drug Administration |
T-Lymphocytes Immune Tolerance Inosine Pranobex Killer Cells |
T-Lymphocytes, Helper-Inducer Acquired Immunodeficiency Syndrome AIDS-Related Complex |
Virus Diseases Lymphatic Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome AIDS-Related Complex Inosine Pranobex Retroviridae Infections Immunologic Deficiency Syndromes |
Anti-Infective Agents RNA Virus Infections Slow Virus Diseases Immunologic Factors Immune System Diseases Therapeutic Uses |
Physiological Effects of Drugs Adjuvants, Immunologic Lentivirus Infections Infection Antiviral Agents Pharmacologic Actions |