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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01339416
Recruitment Status : Completed
First Posted : April 20, 2011
Results First Posted : April 21, 2014
Last Update Posted : April 21, 2014
Johns Hopkins University
University of North Carolina, Chapel Hill
Vanderbilt University
Information provided by (Responsible Party):
ViiV Healthcare

Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Retrospective
Conditions: HIV

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited and analyzed retrospectively from 3 clinical sites in the United States of America (Johns Hopkins University, University of North Carolina at Chapel Hill and Vanderbilt University).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
All Participants Participants who were diagnosed with Human immunodeficiency virus (HIV) infection and received HIV care during January 1, 2000 through December 31, 2010 (574 weeks) with follow-up extended up to 31st December 2011 (up to 626 weeks).

Participant Flow:   Overall Study
    All Participants
STARTED   8202 

  Baseline Characteristics

  Outcome Measures

1.  Primary:   Incidence Rate of Malignancies   [ Time Frame: Up to Week 626 ]

2.  Primary:   Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections   [ Time Frame: Up to Week 626 ]

3.  Primary:   Incidence Rate of Myocardial Infarction   [ Time Frame: Up to Week 626 ]

4.  Primary:   Incidence Rate of Liver Failure   [ Time Frame: Up to Week 626 ]

5.  Primary:   Incidence Rate of Viral Encephalitis   [ Time Frame: Up to Week 626 ]

6.  Secondary:   Incidence Rate of Rhabdomyolysis   [ Time Frame: Up to Week 626 ]

7.  Secondary:   Incidence Rate of Death   [ Time Frame: Up to Week 626 ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Designation of primary and secondary endpoints was based on study team's inputs, as the endpoints were not prioritized in the study protocol.

  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Pfizer Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021

Responsible Party: ViiV Healthcare Identifier: NCT01339416     History of Changes
Other Study ID Numbers: A4001106
First Submitted: March 16, 2011
First Posted: April 20, 2011
Results First Submitted: March 14, 2014
Results First Posted: April 21, 2014
Last Update Posted: April 21, 2014