EuroSIDA As An External Comparator To MOTIVATE Trials

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1181 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-04-30

Study Completion Date

2011-03-31

Brief Summary

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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.

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Detailed Description

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

Conditions

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HIV AIDS

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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)

maraviroc

Intervention Type OTHER

No intervention is distributed during this trial.

Interventions

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maraviroc

No intervention is distributed during this trial.

Intervention Type OTHER

Other Intervention Names

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Selzentry, Celsentri

Eligibility Criteria

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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