EuroSIDA As An External Comparator To MOTIVATE Trials

This study has been completed.

Sponsor:

Collaborators:

Copenhagen HIV Programme

Pfizer

Information provided by:

ViiV Healthcare

ClinicalTrials.gov Identifier:

NCT01329783

First received: March 16, 2011

Last updated: May 13, 2011

Last verified: May 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

March 16, 2011

Last Updated Date

May 13, 2011

Start Date ^ICMJE

April 2007

Primary Completion Date

March 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Malignancy [ Time Frame: Median follow up of 3 years ] [ Designated as safety issue: Yes ]
Opportunistic infection [ Time Frame: Median follow up of 3 years ] [ Designated as safety issue: Yes ]
Myocardial infarction [ Time Frame: Median follow up of 3 years ] [ Designated as safety issue: Yes ]
All cause death [ Time Frame: Median follow up of 3 years ] [ Designated as safety issue: Yes ]
Liver related death [ Time Frame: Median follow up of 3 years ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01329783 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

EuroSIDA As An External Comparator To MOTIVATE Trials

Official Title ^ICMJE

Incidence And Risk Factors For Acquired Immune Deficiency Syndrome (AIDS) Defining And Non-AIDS Defining Malignancies, And Other AIDS Defining Illnesses In The EuroSIDA Study

Brief Summary

Human Immunodeficiency Virus (HIV) infected patients who meet the entry criteria for the maraviroc pivotal trials (Maraviroc versus Optimized Therapy in Viremic Antiretroviral Treatment-Experienced Patients, MOTIVATE) will be identified from the EuroSIDA HIV cohort. The rates of specific clinical adverse events in this identified patient population will be compared with the rates of these events in the participants of the MOTIVATE trials.

Detailed Description

All patients in EuroSIDA cohort that meet the entry criteria of MOTIVATE trials are included without any sampling.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Retrospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Patient aged over 16 at baseline.
Viral Load (VL) > 5000 copies/ml at baseline (and measured in 6 months prior to baseline).
No changes in antiretroviral (ARV) regimens in the month period prior to baseline, or on no ARVs in the month prior to baseline.
> 3 months exposure (sequential or cumulative) to at least 3 of the following;
Any nucleoside or nucleotide reverse transcriptase inhibitor (NRTI)
Non-nucleoside reverse transcriptase inhibitor (NNNRTI)
Protease Inhibitor (PI )
Enfuvirtide

Condition ^ICMJE

HIV
AIDS

Intervention ^ICMJE

Other: maraviroc

No intervention is distributed during this trial.

Other Name: Selzentry, Celsentri

Study Group/Cohort (s)

EuroSIDA sub-cohort

HIV infected patients in the EuroSIDA cohort who meet the entry criteria for maraviroc pivotal clinical trials (MOTIVATE 1 and MOTIVATE 2)

Intervention: Other: 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 ^ICMJE

Completed

Enrollment ^ICMJE

1181

Completion Date

March 2011

Primary Completion Date

March 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patient aged over 16 at baseline.
Viral Load (VL) > 5000 copies/ml at baseline (and measured in 6 months prior to baseline).
No changes in antiretroviral (ARV) regimens in the month period prior to baseline, or on no ARVs in the month prior to baseline.
> 3 months exposure (sequential or cumulative) to at least 3 of the following;
Any nucleoside or nucleotide reverse transcriptase inhibitor (NRTI)
Non-nucleoside reverse transcriptase inhibitor (NNNRTI)
Protease Inhibitor (PI )
Enfuvirtide

Exclusion Criteria:

None

Gender

Both

Ages

16 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT01329783

Other Study ID Numbers ^ICMJE

A4001104

Has Data Monitoring Committee

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer, Inc.

Study Sponsor ^ICMJE

ViiV Healthcare

Collaborators ^ICMJE

Copenhagen HIV Programme
Pfizer

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

ViiV Healthcare

Verification Date

May 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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