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
  Purpose

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 Intervention Phase
HIV
AIDS
Other: maraviroc
Phase 4

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by ViiV Healthcare:

Primary Outcome Measures:
  • 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 ]

Enrollment: 1181
Study Start Date: April 2007
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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:

None

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01329783

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

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01329783     History of Changes
Other Study ID Numbers: A4001104
Study First Received: March 16, 2011
Last Updated: May 13, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 23, 2014