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Safety and efficacy of BAY 50-4798 in patients with HIV infection Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Safety and efficacy of BAY 50-4798 in patients with HIV infection conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Safety and efficacy of BAY 50-4798 in patients with HIV infection Clinical research trials and Safety and efficacy of BAY 50-4798 in patients with HIV infection healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Safety and efficacy of BAY 50-4798 in patients with HIV infection. Safety and efficacy of BAY 50-4798 in patients with HIV infection Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Safety and efficacy of BAY 50-4798 in patients with HIV infection clinical trial. Test subjects typically receive the most effective healthcare possible for their Safety and efficacy of BAY 50-4798 in patients with HIV infection condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Safety and efficacy of BAY 50-4798 in patients with HIV infection  Safety and efficacy of BAY 50-4798 in patients with HIV infection
Safety and efficacy of BAY 50-4798 in patients with HIV infection
For Condition: HIV Infections
Status: Recruiting
Sponsor(s): Bayer Corporation ,
Synopsis: The purpose of this study is to evaluate the safety of the experimental drug Bay 50-4798 in HIV positive patients receiving HAART and to test the drug’s effect on the CD4+ T-cell count.
Details: The immune systems of patients with HIV infection do not produce enough interleukin-2 (IL-2). IL-2 is a protein that helps to activate CD4+ T cells to respond to various infections, including HIV. Bay 50-4798 is a modified recombinant form of IL-2 which may prove to have a tolerable adverse event profile.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Active Control
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: - Documented HIV infection (positive enzyme linked immuno assay (EIA) confirmed by Western Blot). - Age greater than or equal to 18 years. - Plasma HIV viral load less than 10,000 copies/ml (by bDNA assay or less than 14,000 copies/ml by RT-PCR) on at least 2 occasions within 8 weeks prior to study entry with no more than a 0.5 log increase between the most recent and the earlier viral load measurements. - CD4 + T-cell count greater than or equal to 200/mm(3) on at least 2 occasions within 8 weeks of study entry. - On a stable HAART regimen for greater than or equal to 8 weeks. - Karnoffsky Score greater than or equal to 80. - Written informed consent. EXCLUSION CRITERIA: - Prior treatment with IL-2 or an IL-2 analogue. - Pregnancy or breastfeeding. - Use of any known immunomodulators, cytokines, growth factors or systemic corticosteroids (e.g. prednisone greater than or equal to 15 mg/day or equivalent) within 4 weeks prior to study enrollment. - History of an AIDS defining illness by the Centers for Disease Control (CDC) definition within 8 weeks prior to study entry. - Acute bacterial or viral infection within 4 weeks prior to enrollment. - Received an immunization within 4 weeks prior to enrollment. - History of autoimmune disease including psoriasis, inflammatory bowel disease. - Medical history of transplantation (solid organ or bone marrow). - Received an investigational drug in the past 30 days other than Food and Drug Administration (FDA) sanctioned treatment IND antiretroviral agents. - Renal insufficiency with a serum creatinine level greater than 1.5 times the upper limit of normal. - Bone marrow suppression as defined by one or more of the following: granulocyte count less than 1,000 cells/µL; hemoglobin less than 9.0g (females) or less than 9.5g (males); or platelet count less than 75,000 cells/µL. - Evidence of hepatic disease indicated by one or more of the following: SGOT (AST) and/or SGPT (ALT) greater than 5 times the upper limit of normal. Bilirubin greater than 2 times the upper limit of normal (except for patients with known Gilbert's syndrome or those receiving indinavir who may be enrolled if the serum bilirubin is less than or equal to 5 times the upper limit of normal). - Active cardiac disease (coronary artery disease, congestive heart failure or cardiomyopathy) requiring treatment with any of the following medications: antiarrhythmic agents including digitalis, anti-anginal drugs including topical or systemic nitrates, calcium channel blockers, and beta blockers, and afterload reducers including ACE inhibitors. Patients requiring any of these medications solely for the treatment of hypertension remain eligible for the study. - Presence of significant cardiac insufficiency (greater than or equal to New York Heart Association Grade 2). - Diagnosis of an active malignancy requiring treatment with systemic cytotoxic chemotherapy. - Active alcohol or substance abuse which, in the opinion of the investigator, will seriously compromise the subject's ability to adhere with the demands of the study. - Any central nervous system (CNS) disease that requires active treatment with anticonvulsants. - Use of an antimetabolite such as hydroxyurea within 4 weeks prior to study entry. - Known co-infection with Hepatitis B or C virus unless serum transaminases are less than or equal to 2 times the upper limit of normal on at least two occasions within 8 weeks prior to study entry. - Known CD4 Nadir less than 50 cells/mm(3).
Total Enrollment: 100
Location and Contact Information:
UC Davis Medical Center ACTU at CARES *Recruiting*
Sacramento, California, 95814
United States
Recruiting Susan Hulse 916-734-6637
National Institutes of Health *Recruiting*
Bethesda, Maryland, 20892-1880
United States
Recruiting Jocelyn Voell 301-435-7913
Northwestern University Medical School / Northwestern Memorial Hospital *Recruiting*
Chicago, Illinois, 60611
United States
Recruiting Patrick Milne 312-695-5045
Chelsea and Westminster Hospital *Recruiting*
London, , SW10 9NH
United Kingdom
Recruiting Chris Higgs
UAB - Medical Center *Recruiting*
Birmingham, Alabama, 35294-2050
United States
Recruiting Kerry Upton 205-975-7925
University Hospitals of Cleveland *Recruiting*
Cleveland, Ohio, 44106
United States
Recruiting Michael Chance 216-844-8051
UCLA Care Center *Recruiting*
Los Angeles, California, 90095
United States
Recruiting Deborah Tolenaar 310-825-1301
Quest Clinical Research *Recruiting*
San Francisco, California, 94115
United States
Recruiting DA Warren 415-353-0800
Veteran Affairs Palo Alto Health Care System *Recruiting*
Palo Alto, California, 94304
United States
Recruiting Don Schmidgall 650-493-5000
Additional Information:
Study ID Numbers: 10630;
Study Start Date: December 2002
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00059462
Other Hiv Infections Studies:
1. Phase I Trial of the Combination of Zidovudine and Recombinant Interleukin-2 in Patients with Persistent Generalized Lymphadenopathy
2. A Comparative Phase I Clinical Study of HIVAC-1e and Smallpox (Vaccinia) Vaccines in Previously (Vaccinia) Vaccinated and Unvaccinated Volunteers
3. Active Immunization of HIV-Infected Pregnant Women: A Phase I Study of Safety and Immunogenicity of a rgp120/HIV-1 Vaccine (NOTE: Some Patients Receive Placebo)
4. The Effects of r-metHuIFN-gamma on the Lungs of Patients with AIDS
5. A Comparison of 141W94 and Indinavir in HIV-Infected Patients
Related Studies:
Other HIV Infections Clinical Trials
Other California Clinical Trials
Other Sacramento Clinical Trials
Safety and efficacy of BAY 50-4798 in patients with HIV infection
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