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Tracking Information | |||||
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First Received Date ICMJE | April 25, 2003 | ||||
Last Updated Date | May 20, 2009 | ||||
Start Date ICMJE | December 2002 | ||||
Current Primary Outcome Measures ICMJE | |||||
Original Primary Outcome Measures ICMJE | |||||
Change History | Complete list of historical versions of study NCT00059462 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE | |||||
Original Secondary Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Safety and Efficacy of BAY 50-4798 in Patients With HIV Infection | ||||
Official Title ICMJE | 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. | ||||
Brief Summary | 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. |
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Detailed Description | |||||
Study Phase | Phase I, Phase II | ||||
Study Type ICMJE | Interventional | ||||
Study Design ICMJE | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study | ||||
Condition ICMJE | HIV Infections | ||||
Intervention ICMJE |
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Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 82 | ||||
Completion Date | March 2005 | ||||
Primary Completion Date | |||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States, France, United Kingdom | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID ICMJE | NCT00059462 | ||||
Responsible Party | Therapeutic Area Head, Bayer HealthCare AG | ||||
Study ID Numbers ICMJE | 10630 | ||||
Study Sponsor ICMJE | Bayer | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Bayer | ||||
Verification Date | May 2009 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |