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
1 other identifier
observational
1,181
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2007
Longer than P75 for all trials
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
Study Start
First participant enrolled
April 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 16, 2011
CompletedFirst Posted
Study publicly available on registry
April 6, 2011
CompletedMay 16, 2011
May 1, 2011
3.9 years
March 16, 2011
May 13, 2011
Conditions
Outcome Measures
Primary Outcomes (5)
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
Study Arms (1)
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)
Interventions
No intervention is distributed during this trial.
Eligibility 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
You may qualify if:
- 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
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ViiV Healthcarelead
- Copenhagen HIV Programmecollaborator
- Pfizercollaborator
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 16, 2011
First Posted
April 6, 2011
Study Start
April 1, 2007
Primary Completion
March 1, 2011
Study Completion
March 1, 2011
Last Updated
May 16, 2011
Record last verified: 2011-05