EuroSIDA As An External Comparator To MOTIVATE Trials

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

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.

Study Overview

• Status: Completed
• Conditions: HIV; AIDS
• Intervention / Treatment: Other: maraviroc

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 1181

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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)	Other: maraviroc; No intervention is distributed during this trial.; Other Names: Selzentry, Celsentri

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: ViiV Healthcare
• Collaborators: Pfizer; Copenhagen HIV Programme

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: April 1, 2007
• Primary Completion (ACTUAL): March 1, 2011
• Study Completion (ACTUAL): March 1, 2011

Study Registration Dates

• First Submitted: March 16, 2011
• First Submitted That Met QC Criteria: April 4, 2011
• First Posted (ESTIMATE): April 6, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): May 16, 2011
• Last Update Submitted That Met QC Criteria: May 13, 2011
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Anti-HIV Agents; Anti-Retroviral Agents; HIV Fusion Inhibitors; Viral Fusion Protein Inhibitors; CCR5 Receptor Antagonists; Maraviroc
• Other Study ID Numbers: A4001104