Non-Interventional Study Of Celsentri® In Treatment Experienced Patients With CCR5-Tropic HIV-Infection

NCT00850395

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
HIV-1
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

HIV-1 infection. CCR-5 tropic virus. Therapy experienced patient,

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


X4 or D/M tropic virus. Therapy-naive patients.

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Advanced Information
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
 (submitted: July 5, 2012)
79
Original Estimated Enrollment
 (submitted: February 24, 2009)
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
Sexes Eligible for Study:All
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
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account ViiV Healthcare
Verification Date November 2012