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ABOUT THIS 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.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
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
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 |
| |||
| Condition |
| |||
| 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 | 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:
Exclusion Criteria: None | |||
| Sex/Gender |
| |||
| 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 |
| |||
| Investigators |
| |||
| PRS Account | ViiV Healthcare | |||
| Verification Date | May 2011 | |||