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The Safety and Effectiveness of Isoprinosine in Patients with Weakened Immune Systems and Lymph Node Disease Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on The Safety and Effectiveness of Isoprinosine in Patients with Weakened Immune Systems and Lymph Node Disease conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. The Safety and Effectiveness of Isoprinosine in Patients with Weakened Immune Systems and Lymph Node Disease Clinical research trials and The Safety and Effectiveness of Isoprinosine in Patients with Weakened Immune Systems and Lymph Node Disease health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including The Safety and Effectiveness of Isoprinosine in Patients with Weakened Immune Systems and Lymph Node Disease. The Safety and Effectiveness of Isoprinosine in Patients with Weakened Immune Systems and Lymph Node Disease Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a The Safety and Effectiveness of Isoprinosine in Patients with Weakened Immune Systems and Lymph Node Disease clinical trial. Participants oftentimes recieve the most expert healthcare available for their The Safety and Effectiveness of Isoprinosine in Patients with Weakened Immune Systems and Lymph Node Disease condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "T" Clinical Trials Conditions > The Safety and Effectiveness of Isoprinosine in Patients with Weakened Immune Systems and Lymph Node Disease The Safety and Effectiveness of Isoprinosine in Patients with Weakened Immune Systems and Lymph Node Disease
The Safety and Effectiveness of Isoprinosine in Patients with Weakened Immune Systems and Lymph Node Disease
For Condition: Lymphatic Disease,HIV Infections
Status: Completed
Sponsor(s): Newport Pharmaceuticals International ,
Synopsis: 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: o Increase in natural killer (NK) cell activity. o Increase in total T-cells (OKT-11). o Increases in absolute number and percentage of T-helper cells (OKT-4).
Details:
Eligibility:
Study Type: Interventional, Treatment, Double-Blind
Minimum Age/Maximum Age: 18 Years/50 Years
Genders: Male
Protocol Entry 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 or Epstein-Barr virus. - Heart disease (especially if receiving cardiac glycosides). - Hemophilia. Patients with the following are excluded: - Kaposi's sarcoma or overt opportunistic infections as follows: - Candida albicans, Pneumocystis carinii, Herpes simplex, Cryptococcus neoformans, Histoplasma capsulatum, Mycobacterium avium-intracellulare, Toxoplasma gondii, Legionella, Cryptosporidium, Isospora, and Papovavirus. - Active evidence of infectious mononucleosis caused by Epstein-Barr virus (EBV) or cytomegalovirus (CMV) as determined by heterophil test (EBV) or cell culture (CMV). - 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. - Hemophilia. Prior Medication: Excluded: - Steroids. - Cytotoxic immunosuppressive agents. - Antiviral medicine. 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.
Total Enrollment:
Location and Contact Information:
Newport Pharmaceuticals International Inc
Laguna Hills, California, 92656
United States
Additional Information:
Study ID Numbers: 008C; ISO-106-USA
Study Start Date:
Record last reviewed: June 1989
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002296
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3. Thalidomide for Treatment of Oral and Esophageal Aphthous Ulcers and HIV Viremia in Patients With HIV Infection
4. Four-Drug Combination Therapy with Zidovudine, Lamivudine, 1592U89 (Abacavir), and 141W94 (Amprenavir) in HIV-Infected Patients
5. Effect of Fluconazole, Clarithromycin, and Rifabutin on the Pharmacokinetics of Sulfamethoxazole-Trimethoprim and Dapsone and Their Hydroxylamine Metabolites
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The Safety and Effectiveness of Isoprinosine in Patients with Weakened Immune Systems and Lymph Node Disease
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