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| Sponsor: | 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:
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 |
|
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 |