HIV Cohort Study At Johns Hopkins University, University of North Carolina at Chapel Hill and Vanderbilt University
NCT01339416
Last updated date
ABOUT THIS STUDY
Human Immunodeficiency Virus (HIV) infected patients in the HIV registries of Johns Hopkins
University, University of North Carolina and Vanderbilt University will be followed in the
routine clinical care to estimate the rates of prespecified clinical events in this
population.
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
0 +
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- HIV infection.
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 | HIV Cohort Study At Johns Hopkins University, University of North Carolina at Chapel Hill and Vanderbilt University | |||
| Official Title | Clinical Adverse Events In HIV-Infected Patients | |||
| Brief Summary | Human Immunodeficiency Virus (HIV) infected patients in the HIV registries of Johns Hopkins University, University of North Carolina and Vanderbilt University will be followed in the routine clinical care to estimate the rates of prespecified clinical events in this population. | |||
| Detailed Description | All patients identified in the HIV registries will be 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 | HIV infected patients seeking treatment at Johns Hopkins University, Vanderbilt University and University of North Carolina at Chapel Hill | |||
| Condition |
| |||
| Intervention | Not Provided | |||
| Study Groups/Cohorts | HIV infected cohort
HIV infected patients in the HIV cohorts at the three participating hospitals | |||
| 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 | 8202 | |||
| Original Estimated Enrollment | 5000 | |||
| Actual Study Completion Date | May 2013 | |||
| Actual Primary Completion Date | May 2013 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender |
| |||
| Ages | 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 | NCT01339416 | |||
| Other Study ID Numbers | A4001106 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| Responsible Party | ViiV Healthcare | |||
| Study Sponsor | ViiV Healthcare | |||
| Collaborators |
| |||
| Investigators |
| |||
| PRS Account | ViiV Healthcare | |||
| Verification Date | March 2014 | |||