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| Sponsored by: |
Newport Pharmaceuticals International |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002296 |
Purpose
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 |
|---|---|
|
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 |
Eligibility| 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.
Contacts and Locations
More Information
| Study ID Numbers: | 008C, ISO-106-USA |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002296 History of Changes |
| 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 |
|
Sexually Transmitted Diseases, Viral Immunologic Factors Acquired Immunodeficiency Syndrome Adjuvants, Immunologic AIDS-Related Complex Inosine Pranobex Antiviral Agents |
Immunologic Deficiency Syndromes Virus Diseases Lymphatic Diseases HIV Infections Sexually Transmitted Diseases Retroviridae Infections |
|
Anti-Infective Agents RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Immunologic Factors Immune System Diseases Physiological Effects of Drugs Acquired Immunodeficiency Syndrome Adjuvants, Immunologic Inosine Pranobex Infection |
Antiviral Agents Pharmacologic Actions Immunologic Deficiency Syndromes Virus Diseases Lymphatic Diseases HIV Infections Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections |