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Completed

NCT Number: NCT01329783

EuroSIDA As An External Comparator To MOTIVATE Trials

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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Key information

Conditions

HIV AIDS Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

maraviroc

Other

No intervention is distributed during this trial.

Other names: Selzentry, Celsentri

Primary outcomes

  1. Malignancy

    Time frame: Median follow up of 3 years

  2. Opportunistic infection

    Time frame: Median follow up of 3 years

  3. Myocardial infarction

    Time frame: Median follow up of 3 years

  4. All cause death

    Time frame: Median follow up of 3 years

  5. Liver related death

    Time frame: Median follow up of 3 years

Sponsors and collaborators

Lead sponsor

ViiV Healthcare

Industry

Collaborators

  • Copenhagen HIV Programme
  • Pfizer

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Apr 6, 2011
Registry last updated
May 16, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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