EuroSIDA As An External Comparator To MOTIVATE Trials

Completed

• Conditions: HIV; AIDS
• Interventions: Other: maraviroc

• Registration Number: NCT01329783
• Lead Sponsor: ViiV Healthcare

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 Timeline

• Study Start: 2007-04
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Study First Submitted: 2011-03-16
• Study First Submitted QC: 2011-04-04
• Study First Posted: 2011-04-06
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-13
• Last Update Posted: 2011-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1181

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Malignancy	Median follow up of 3 years
Opportunistic infection	Median follow up of 3 years
Myocardial infarction	Median follow up of 3 years
All cause death	Median follow up of 3 years
Liver related death	Median follow up of 3 years