A Study of Isoprinosine in Patients With Lymph Node Disease
This study has been completed.
Sponsor:
Newport Pharmaceuticals International
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002297
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: June 1989
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Purpose
The objectives of this study are to determine the effects of isoprinosine in patients diagnosed as having unexplained generalized lymphadenopathy. Variables to be examined will include:
Signs and symptoms:
- Lymphadenopathy.
- Fever.
- Weight loss.
- Occurrence of opportunistic infections.
Cell-mediated immune system parameters:
- T-helper cell (OKT4) numbers and proportions.
- T-suppressor cell (OKT8) numbers and proportions.
- Natural killer (NK) cell activity.
- Lymphocyte blastogenic response to phytohemagglutinin (PHA).
- Lymphocyte blastogenic response to pokeweed mitogen (PWM).
- Immunoglobulin (IgG, IgA, IgM, IgE, IgD) profile.
- Circulating immune complexes. Infections characteristically associated with AIDS, such as Candida albicans, Pneumocystis carinii pneumonia, Cytomegalovirus, Herpes simplex, Cryptococcus, Histoplasma, Toxoplasma, Cryptosporidium, Mycobacterium avium- intracellulare, Legionella, and Isospora.
Safety parameters:
- Blood chemistry including serum uric acid (PurposeA-12).
- Complete blood count (CBC).
- Platelet count.
| 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 Double-Blind Placebo-Controlled Study to Investigate the Action of Isoprinosine (Inosiplex) in Patients With Unexplained 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 and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Exclusion Criteria
Co-existing Condition:
Patients with a history of gout, uric acid urolithiasis, uric acid nephrolithiasis, renal dysfunction, or gastric ulceration are excluded.
Concurrent Medication:
Excluded:
- Systemic corticosteroids.
- Cytotoxic immunosuppressive agents.
- Radiotherapy.
Critically ill patients or those with CDC-defined AIDS are excluded.
Prior Medication:
Excluded within 1 month of study entry:
- Immunotherapy.
Patients with persistent generalized lymphadenopathy (PGL).
Contacts and Locations More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00002297 History of Changes |
| Other Study ID Numbers: | 008A, ISO-103-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:
|
Inosine Pranobex 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 May 16, 2013