NCT00850395

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®.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2009

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 25, 2009

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
1 year until next milestone

Results Posted

Study results publicly available

October 15, 2012

Completed
Last Updated

November 7, 2012

Status Verified

November 1, 2012

Enrollment Period

2.3 years

First QC Date

February 23, 2009

Results QC Date

September 11, 2012

Last Update Submit

November 5, 2012

Conditions

HIV-1

Keywords

HIV-1non-interventionalCCR-5 tropic virustherapy experienced patients

Outcome Measures

Primary Outcomes (9)

  • Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 3

    Baseline, Month 3

  • Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 6

    Baseline, Month 6

  • Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 12

    Baseline, Month 12

  • Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 3

    Baseline, Month 3

  • Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 6

    Baseline, Month 6

  • Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 12

    Baseline, Month 12

  • Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at 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

    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

    Participants were classified based on the severity as mild (Category A), moderate (Category B), and severe (Category C).

    Month 12

Secondary Outcomes (4)

  • Change From Baseline in Acquired Immune Deficiency Syndrome (AIDS) Clinical Trials Group (ACTG) Symptom Distress Module (SDM) Overall Score at Months 6 and 12

    Baseline, Months 6, 12

  • Number of Participants With Human Immunodeficiency Virus (HIV) Response

    Month 12

  • Physician's Assessment of Efficacy

    Month 12

  • Number of Participants Taking Concomitant Therapy

    Baseline, Month 12

Study Arms (1)

1

Non-Interventional

Drug: maraviroc

Interventions

maravirocDRUG

No intervention; any procedure at the discretion of the treating physician, in line with the SmPC

Also known as: Selzentry, Celsentri
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Interventions

Maraviroc

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Limitations and Caveats

Designation of outcomes as primary and secondary was based on study team input as study did not specify primary or secondary outcome measures.

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2009

First Posted

February 25, 2009

Study Start

July 1, 2009

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

November 7, 2012

Results First Posted

October 15, 2012

Record last verified: 2012-11