Non-Interventional Study Of Celsentri® In Treatment Experienced Patients With CCR5-Tropic HIV-Infection
NCT00850395
ABOUT THIS STUDY
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Contact a representative by phone, email, or visiting the study website. Please see the references below:
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1-800-718-1021
HIV-1 infection. CCR-5 tropic virus. Therapy experienced patient,
X4 or D/M tropic virus. Therapy-naive patients.
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Descriptive Information | ||||
---|---|---|---|---|
Brief Title | Non-Interventional Study Of Celsentri® In Treatment Experienced Patients With CCR5-Tropic HIV-Infection | |||
Official Title | 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®. | |||
Detailed Description | Non interventional study, inclusion and exclusion criteria defined by the labelling of Celsentri (Maraviroc). | |||
Study Type | Observational | |||
Study Design | 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, | |||
Condition | HIV-1 | |||
Intervention | Drug: maraviroc
No intervention; any procedure at the discretion of the treating physician, in line with the SmPC Other Name: Selzentry, Celsentri | |||
Study Groups/Cohorts | 1
Non-Interventional Intervention: Drug: maraviroc | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment | 79 | |||
Original Estimated Enrollment | 300 | |||
Actual Study Completion Date | October 2011 | |||
Actual Primary Completion Date | October 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria: HIV-1 infection. CCR-5 tropic virus. Therapy experienced patient, Exclusion Criteria: X4 or D/M tropic virus. Therapy-naive patients. | |||
Sex/Gender |
| |||
Ages | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Not Provided | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT00850395 | |||
Other Study ID Numbers | A4001070 CELTROP | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | ViiV Healthcare | |||
Study Sponsor | ViiV Healthcare | |||
Collaborators | Pfizer | |||
Investigators |
| |||
PRS Account | ViiV Healthcare | |||
Verification Date | November 2012 |