Non-Interventional Study Of Celsentri® In Treatment Experienced Patients With CCR5-Tropic HIV-Infection
This study has been completed.
Sponsor:
ViiV Healthcare
Collaborator:
Pfizer
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT00850395
First received: February 23, 2009
Last updated: November 5, 2012
Last verified: November 2012
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| Tracking Information | |||||
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| First Received Date ICMJE | February 23, 2009 | ||||
| Last Updated Date | November 5, 2012 | ||||
| Start Date ICMJE | July 2009 | ||||
| Primary Completion Date | October 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00850395 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
Quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Non-Interventional Study Of Celsentri® In Treatment Experienced Patients With CCR5-Tropic HIV-Infection | ||||
| Official Title ICMJE | Non-Interventional Study Of Celsentri® In Treatment Experienced Patients Infected With CCR5 Tropic HIV-1 | ||||
| Brief Summary | Aim of the study is to gain more knowledge about efficacy of CELSENTRI® in daily clinical practice and obtain information about the quality of life of patients using CELSENTRI®. |
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| Detailed Description | Non interventional study, inclusion and exclusion criteria defined by the labelling of Celsentri (Maraviroc). |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Time Perspective: Prospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | HIV-1 infected, therapy-experienced patients, CCR5-tropic virus, |
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| Condition ICMJE | HIV-1 | ||||
| Intervention ICMJE | Drug: maraviroc
No intervention; any procedure at the discretion of the treating physician, in line with the SmPC
Other Name: Selzentry, Celsentri |
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| Study Group/Cohort (s) | 1
Non-Interventional
Intervention: Drug: maraviroc |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 79 | ||||
| Completion Date | October 2011 | ||||
| Primary Completion Date | October 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: HIV-1 infection. CCR-5 tropic virus. Therapy experienced patient, Exclusion Criteria: X4 or D/M tropic virus. Therapy-naive patients. |
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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 | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00850395 | ||||
| Other Study ID Numbers ICMJE | A4001070, CELTROP | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | ViiV Healthcare | ||||
| Study Sponsor ICMJE | ViiV Healthcare | ||||
| Collaborators ICMJE | Pfizer | ||||
| Investigators ICMJE |
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| Information Provided By | ViiV Healthcare | ||||
| Verification Date | November 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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