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

November 5, 2012 updated by: ViiV Healthcare

Non-Interventional Study Of Celsentri® In Treatment Experienced Patients Infected With CCR5 Tropic HIV-1

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®.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Non interventional study, inclusion and exclusion criteria defined by the labelling of Celsentri (Maraviroc).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
79

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

HIV-1 infected, therapy-experienced patients, CCR5-tropic virus,

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
1
Non-Interventional
Drug: maraviroc
No intervention; any procedure at the discretion of the treating physician, in line with the SmPC
Other Names:
  • Selzentry, Celsentri

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 3
Time Frame: Baseline, Month 3
Baseline, Month 3
Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 6
Time Frame: Baseline, Month 6
Baseline, Month 6
Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 12
Time Frame: Baseline, Month 12
Baseline, Month 12
Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 3
Time Frame: Baseline, Month 3
Baseline, Month 3
Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 6
Time Frame: Baseline, Month 6
Baseline, Month 6
Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 12
Time Frame: Baseline, Month 12
Baseline, Month 12
Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 3
Time Frame: Month 3
Participants were classified based on the severity as mild (Category A), moderate (Category B), and severe (Category C).
Month 3
Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 6
Time Frame: Month 6
Participants were classified based on the severity as mild (Category A), moderate (Category B), and severe (Category C).
Month 6
Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 12
Time Frame: Month 12
Participants were classified based on the severity as mild (Category A), moderate (Category B), and severe (Category C).
Month 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Acquired Immune Deficiency Syndrome (AIDS) Clinical Trials Group (ACTG) Symptom Distress Module (SDM) Overall Score at Months 6 and 12
Time Frame: Baseline, Months 6, 12
SDM consists of the 20 items questionnaire, each item rated from 0 to 4 where 0 (complete absence of symptom) and 4 (very bothersome symptom). Overall score calculated as the sum of the scores for each of the 20 items of the questionnaire and ranged from 0 (best health) and 80 (worst health). A positive change from baseline indicates a decline in a participant's quality of life over that period.
Baseline, Months 6, 12
Number of Participants With Human Immunodeficiency Virus (HIV) Response
Time Frame: Month 12
Response was defined as a HIV-1 RNA count of less than 50 copies/mL.
Month 12
Physician's Assessment of Efficacy
Time Frame: Month 12
Number of participants with each grade of efficacy as assessed by the physician was reported on the 5 point categorical scale: excellent, very good, good, fair, poor.
Month 12
Number of Participants Taking Concomitant Therapy
Time Frame: Baseline, Month 12
Participants taking HIV/AIDS concomitant medication at Month 12, at Baseline and Month 12 were reported. It included Emtricitabine/tenofovir disoproxil fumarate(FTC/TDF),Raltegravir(RAL), Ritonavir (RTV), Darunavir(DRV), Kaletra, Atazanavir sulfate(ATV), Abacavir sulfate/lamivudine(ABC/LAM), Tenofovir disoproxil fumarate(TDF), Etravirine(ETR), Lamivudine (LAM), Zidovudine W/lamivudine(ZDV W/LAM), Nevirapine(NVP), Saquinavir mesilate(SQV), Trizivir(TZV), Zidovudine(ZDV), Abacavir sulfate(ABC), Emtricitabine(FTC),Entecavir(ETV).
Baseline, Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ViiV Healthcare

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2009

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2011

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 23, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2009

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 25, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 7, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A4001070
  • CELTROP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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