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

This study is enrolling participants by invitation only.
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: May 28, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Phase
HIV
AIDS
 Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Clinical Adverse Events In HIV-Infected Patients

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by ViiV Healthcare:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 5000
Study Start Date: October 2008
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
HIV infected cohort
HIV infected patients in the HIV cohorts at the three participating hospitals

Detailed Description:

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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

Inclusion Criteria:

  • HIV infection.

Exclusion Criteria:

  • None.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01339416

Sponsors and Collaborators
ViiV Healthcare
Johns Hopkins University
University of North Carolina, Chapel Hill
Vanderbilt University
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT01339416     History of Changes
Other Study ID Numbers: A4001106
Study First Received: March 16, 2011
Last Updated: May 28, 2013
Health Authority: United States: Investigational Review Board

ClinicalTrials.gov processed this record on June 17, 2013