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Sponsored by: |
Bayer |
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Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00059462 |
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.
Condition | Intervention | Phase |
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HIV Infections |
Drug: Interleukin-2 SA |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control |
Estimated Enrollment: | 100 |
Study Start Date: | December 2002 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
United States, Alabama | |
UAB - Medical Center | |
Birmingham, Alabama, United States, 35294-2050 | |
United States, California | |
Quest Clinical Research | |
San Francisco, California, United States, 94115 | |
Veteran Affairs Palo Alto Health Care System | |
Palo Alto, California, United States, 94304 | |
UCLA Care Center | |
Los Angeles, California, United States, 90095 | |
UC Davis Medical Center ACTU at CARES | |
Sacramento, California, United States, 95814 | |
United States, Illinois | |
Northwestern University Medical School / Northwestern Memorial Hospital | |
Chicago, Illinois, United States, 60611 | |
United States, Maryland | |
National Institutes of Health | |
Bethesda, Maryland, United States, 20892-1880 | |
United States, Ohio | |
University Hospitals of Cleveland | |
Cleveland, Ohio, United States, 44106 | |
United Kingdom | |
Chelsea and Westminster Hospital | |
London, United Kingdom, SW10 9NH |
Study ID Numbers: | 10630 |
Study First Received: | April 25, 2003 |
Last Updated: | October 26, 2006 |
ClinicalTrials.gov Identifier: | NCT00059462 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Treatment experienced |
Virus Diseases Sexually Transmitted Diseases, Viral Aldesleukin Analgesics, Non-Narcotic Interleukin-2 HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Peripheral Nervous System Agents Analgesics Retroviridae Infections Immunologic Deficiency Syndromes |
Communicable Diseases RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Immune System Diseases Antineoplastic Agents Physiological Effects of Drugs Acquired Immunodeficiency Syndrome Infection Pharmacologic Actions Immunologic Deficiency Syndromes Virus Diseases |
Sensory System Agents Analgesics, Non-Narcotic Interleukin-2 HIV Infections Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections Peripheral Nervous System Agents Analgesics Central Nervous System Agents Retroviridae Infections |