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EuroSIDA As An External Comparator To MOTIVATE Trials

Sponsor
ViiV Healthcare (Industry)
Overall Status
Completed
CT.gov ID
NCT01329783
Collaborator
Copenhagen HIV Programme (Other), Pfizer (Industry)
1,181
Enrollment
47
Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: maraviroc

Detailed Description

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

Study Design

Study Type:
Observational
Actual Enrollment :
1181 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
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
Study Start Date :
Apr 1, 2007
Actual Primary Completion Date :
Mar 1, 2011
Actual Study Completion Date :
Mar 1, 2011

Arms and Interventions

Arm 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Malignancy [Median follow up of 3 years]

    2. Opportunistic infection [Median follow up of 3 years]

    3. Myocardial infarction [Median follow up of 3 years]

    4. All cause death [Median follow up of 3 years]

    5. Liver related death [Median follow up of 3 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • ViiV Healthcare
    • Copenhagen HIV Programme
    • Pfizer

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01329783
    Other Study ID Numbers:
    • A4001104
    First Posted:
    Apr 6, 2011
    Last Update Posted:
    May 16, 2011
    Last Verified:
    May 1, 2011
    Additional relevant MeSH terms:
    Maraviroc

    Study Results

    No Results Posted as of May 16, 2011