HIV Cohort Study At Johns Hopkins University, University of North Carolina at Chapel Hill and Vanderbilt University

This study has been completed.
Sponsor:
Collaborators:
Johns Hopkins University
University of North Carolina, Chapel Hill
Vanderbilt University
Pfizer
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT01339416
First received: March 16, 2011
Last updated: September 30, 2013
Last verified: September 2013

March 16, 2011
September 30, 2013
March 2009
May 2013   (final data collection date for primary outcome measure)
  • Incidence rate of Malignancies [ Time Frame: Median follow up of 3 years ] [ Designated as safety issue: Yes ]
  • Incidence rate of AIDS defining opportunistic infections [ Time Frame: Median follow up of 3 years ] [ Designated as safety issue: Yes ]
  • Incidence rate of Myocardial infarction [ Time Frame: Median follow up of 3 years ] [ Designated as safety issue: Yes ]
  • Incidence rate of Liver failure [ Time Frame: Median follow up of 3 years ] [ Designated as safety issue: Yes ]
  • Incidence rate of Viral encephalitis [ Time Frame: Median follow up of 3 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01339416 on ClinicalTrials.gov Archive Site
  • Incidence rate of Rhabdomyolysis [ Time Frame: Median follow up of 3 years ] [ Designated as safety issue: Yes ]
  • Incidence rate of Death [ Time Frame: Median follow up of 3 years ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
HIV Cohort Study At Johns Hopkins University, University of North Carolina at Chapel Hill and Vanderbilt University
Clinical Adverse Events In HIV-Infected Patients

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.

All patients identified in the HIV registries will be included without any sampling

Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

HIV infected patients seeking treatment at Johns Hopkins University, Vanderbilt University and University of North Carolina at Chapel Hill

  • HIV
  • AIDS
Not Provided
HIV infected cohort
HIV infected patients in the HIV cohorts at the three participating hospitals
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8202
May 2013
May 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • HIV infection.

Exclusion Criteria:

  • None.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01339416
A4001106
No
ViiV Healthcare
ViiV Healthcare
  • Johns Hopkins University
  • University of North Carolina, Chapel Hill
  • Vanderbilt University
  • Pfizer
Study Director: Pfizer CT.gov Call Center Pfizer
ViiV Healthcare
September 2013

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