EuroSIDA As An External Comparator To MOTIVATE Trials

This study has been completed.
Sponsor:
Collaborators:
Copenhagen HIV Programme
Pfizer
Information provided by:
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT01329783
First received: March 16, 2011
Last updated: May 13, 2011
Last verified: May 2011

March 16, 2011
May 13, 2011
April 2007
March 2011   (final data collection date for primary outcome measure)
  • Malignancy [ Time Frame: Median follow up of 3 years ] [ Designated as safety issue: Yes ]
  • Opportunistic infection [ Time Frame: Median follow up of 3 years ] [ Designated as safety issue: Yes ]
  • Myocardial infarction [ Time Frame: Median follow up of 3 years ] [ Designated as safety issue: Yes ]
  • All cause death [ Time Frame: Median follow up of 3 years ] [ Designated as safety issue: Yes ]
  • Liver related death [ Time Frame: Median follow up of 3 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01329783 on ClinicalTrials.gov Archive Site
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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.

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

Observational
Observational Model: Cohort
Time Perspective: Retrospective
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Non-Probability Sample
  • 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
  • HIV
  • AIDS
Other: maraviroc
No intervention is distributed during this trial.
Other Name: Selzentry, Celsentri
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)
Intervention: Other: maraviroc
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1181
March 2011
March 2011   (final data collection date for primary outcome measure)

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

Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01329783
A4001104
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ViiV Healthcare
  • Copenhagen HIV Programme
  • Pfizer
Study Director: Pfizer CT.gov Call Center Pfizer
ViiV Healthcare
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP