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EuroSIDA As An External Comparator To MOTIVATE Trials

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ClinicalTrials.gov Identifier: NCT01329783
Recruitment Status : Completed
First Posted : April 6, 2011
Last Update Posted : May 16, 2011
Sponsor:
Collaborators:
Information provided by:

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
HIV AIDS Other: maraviroc Phase 4

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 : April 2007
Primary Completion Date : March 2011
Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Maraviroc
U.S. FDA Resources

Groups and Cohorts

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 Name: Selzentry, Celsentri


Outcome Measures

Primary Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01329783


Sponsors and Collaborators
ViiV Healthcare
Copenhagen HIV Programme
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01329783     History of Changes
Other Study ID Numbers: A4001104
First Posted: April 6, 2011    Key Record Dates
Last Update Posted: May 16, 2011
Last Verified: May 2011

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Maraviroc
CCR5 Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents