A Multi-Center Randomized Double-Blind Placebo-Controlled Study To Investigate the Effect of Isoprinosine in Immunodepressed Patients With Uncomplicated Generalized Lymphadenopathy
This study has been completed.
Sponsor:
Newport Pharmaceuticals International
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002061
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: June 1989
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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 immunologic parameters:
- Increase in natural killer (NK) cell activity.
- Increase in total T-cells (OKT-11).
- Increases in absolute number and percentages of T-helper cells (OKT-4).
| Condition | Intervention |
|---|---|
|
Lymphatic Disease HIV Infections |
Drug: Inosine pranobex |
| Study Type: | Interventional |
| Study Design: | Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Multi-Center Randomized Double-Blind Placebo-Controlled Study To Investigate the Effect of Isoprinosine in Immunodepressed Patients With Uncomplicated Generalized Lymphadenopathy |
Resource links provided by NLM:
Further study details as provided by NIH AIDS Clinical Trials Information Service:
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Exclusion Criteria
Co-existing Condition:
Patients with the following are excluded:
- History of gout, uric acid urolithiasis, uric acid nephrolithiasis, renal dysfunction, and severe gastric ulcer.
- Lymphoid malignancy.
- Infectious mononucleosis caused by cytomegalovirus (CMV) or Epstein-Barr virus (EBV).
- Heart disease (especially if receiving cardiac glycosides).
- Hemophilia.
Patients with the following are excluded:
- Kaposi's sarcoma or overt opportunistic infections.
- Active evidence of infectious mononucleosis caused by Epstein-Barr virus (EBV) or cytomegalovirus (CMV) as determined by heterophile test (EBV) or cell culture (CMV).
- A history of gout, uric acid urolithiasis, uric acid nephrolithiasis, renal dysfunction, and severe gastric ulcer.
- Critical illness.
- Condition requiring hospitalization.
- Women of childbearing age are excluded.
Prior Medication:
Excluded:
- Steroids, cytotoxic immunosuppressive agents.
- Antiviral medicine.
- Excluded within 1 month of study entry:
- Immunomodulators (including Isoprinosine).
Prior Treatment:
Excluded:
- Radiotherapy.
Patients who have unexplained immunodepression and are at risk of developing AIDS.
- Patients with prolonged generalized lymphadenopathy for 3 or more months (greater than 1 cm at two or more noncontiguous sites).
IV drug abuse.
Contacts and Locations More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00002061 History of Changes |
| Other Study ID Numbers: | 008B, ISO-105-USA |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by NIH AIDS Clinical Trials Information Service:
|
T-Lymphocytes Immune Tolerance Inosine Pranobex Killer Cells |
T-Lymphocytes, Helper-Inducer Acquired Immunodeficiency Syndrome AIDS-Related Complex |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lymphatic Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes |
Immune System Diseases Slow Virus Diseases Inosine Pranobex Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antiviral Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013