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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: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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 |
|---|---|
| Experimental: Arm 1 |
Drug: Interleukin-2 SA
HAART and Bay 50-4798
|
| Active Comparator: Arm 2 |
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 | |
| Palo Alto, California, United States, 94304-1207 | |
| San Francisco, California, United States, 94115 | |
| 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 | |
| London, Greater London, United Kingdom, SW10 9NH | |
| Study Director: | Bayer Study Director | Bayer |
More Information
| Responsible Party: | Therapeutic Area Head, Bayer HealthCare AG |
| ClinicalTrials.gov Identifier: | NCT00059462 History of Changes |
| Obsolete Identifiers: | NCT00048191 |
| Other Study ID Numbers: | 10630 |
| Study First Received: | April 25, 2003 |
| Last Updated: | May 20, 2009 |
| Health Authority: | United States: Food and Drug Administration |
|
Treatment experienced |
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Aldesleukin Interleukin-2 |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |