EuroSIDA As An External Comparator To MOTIVATE Trials

NCT01329783

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
HIV, AIDS
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
16 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


None

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Advanced Information
Descriptive Information
Brief Title EuroSIDA As An External Comparator To MOTIVATE Trials
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
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.
Detailed Description All patients in EuroSIDA cohort that meet the entry criteria of MOTIVATE trials are included without any sampling.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • HIV
  • AIDS
Intervention Other: maraviroc
No intervention is distributed during this trial.
Other Name: Selzentry, Celsentri
Study Groups/Cohorts 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 4, 2011)
1181
Original Actual Enrollment Same as current
Actual Study Completion Date March 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility 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

Sex/Gender
Sexes Eligible for Study:All
Ages 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01329783
Other Study ID Numbers A4001104
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor ViiV Healthcare
Collaborators
  • Copenhagen HIV Programme
  • Pfizer
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account ViiV Healthcare
Verification Date May 2011