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| Sponsored by: |
Bayer |
|---|---|
| Information provided by: | Bayer |
| ClinicalTrials.gov Identifier: | NCT00059462 |
Purpose
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 |
|---|---|---|
|
HIV Infections |
Drug: Interleukin-2 SA Drug: HAART |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Phase I/II Randomized, Double Blind, Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of Subcutaneous Bay 50-4798 Administration in Patients With HIV Infection on Highly Active Antiretroviral Therapy (HAART) Compared to Patients on HAART Alone. |
| Enrollment: | 82 |
| Study Start Date: | December 2002 |
| Study Completion Date: | March 2005 |
| Arms | Assigned Interventions |
|---|---|
| Arm 1: Experimental |
Drug: Interleukin-2 SA
HAART and Bay 50-4798
|
| Arm 2: Active Comparator |
Drug: HAART
HAART alone
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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).
Contacts and Locations| United States, Alabama | |
| Birmingham, Alabama, United States, 35294 | |
| United States, California | |
| Davis, California, United States, 95616 | |
| Los Angeles, California, United States, 90095 | |
| San Francisco, California, United States, 94115 | |
| Palo Alto, California, United States, 94304-1207 | |
| United States, Illinois | |
| Chicago, Illinois, United States, 60611-2908 | |
| Chicago, Illinois, United States, 60612 | |
| United States, Maryland | |
| Bethesda, Maryland, United States, 20892 | |
| United States, Ohio | |
| Cleveland, Ohio, United States, 44106-2602 | |
| France | |
| CRETEIL, France, 94010 | |
| United Kingdom, Greater London | |
| London, Greater London, United Kingdom, SW10 9NH | |
| Study Director: | Bayer Study Director | Bayer |
More Information
| Responsible Party: | Bayer HealthCare AG ( Therapeutic Area Head ) |
| Study ID Numbers: | 10630 |
| Study First Received: | April 25, 2003 |
| Last Updated: | May 20, 2009 |
| ClinicalTrials.gov Identifier: | NCT00059462 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Treatment experienced |
|
Sexually Transmitted Diseases, Viral Anti-HIV Agents Acquired Immunodeficiency Syndrome Antiviral Agents Immunologic Deficiency Syndromes Virus Diseases Aldesleukin Anti-Retroviral Agents |
HIV Infections Interleukin-2 Analgesics, Non-Narcotic Sexually Transmitted Diseases Analgesics Peripheral Nervous System Agents Retroviridae Infections |
|
Anti-Infective Agents Communicable Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Antineoplastic Agents Physiological Effects of Drugs Infection Anti-Retroviral Agents Sensory System Agents Therapeutic Uses Analgesics Retroviridae Infections RNA Virus Infections Anti-HIV Agents |
Immune System Diseases Acquired Immunodeficiency Syndrome Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Virus Diseases Aldesleukin HIV Infections Interleukin-2 Analgesics, Non-Narcotic Sexually Transmitted Diseases Lentivirus Infections Peripheral Nervous System Agents Central Nervous System Agents |