NCT00801515

Brief Summary

This is a compassionate study to provide continued access to maraviroc for only those subjects completing study A4001029 who are showing clinical benefit. Assessments of safety and tolerability of maraviroc when added to OBT will be continued.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2009

Geographic Reach
1 country

1 active site

Status
unknown

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

December 2, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 3, 2008

Completed
8 months until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

July 25, 2011

Status Verified

July 1, 2011

Enrollment Period

1.9 years

First QC Date

December 2, 2008

Last Update Submit

July 21, 2011

Conditions

Keywords

CompassionateHIVCCR5

Interventions

150 mg twice per day

Also known as: Celsentri

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients having completed study A4001029 in Canada and still deriving clinical benefit.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Montreal, Quebec, H3G 1A4, Canada

Location

Related Links

MeSH Terms

Interventions

Maraviroc

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
expanded access
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 2, 2008

First Posted

December 3, 2008

Study Start

August 1, 2009

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

July 25, 2011

Record last verified: 2011-07

Locations