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

This study has been completed.
Johns Hopkins University
University of North Carolina, Chapel Hill
Vanderbilt University
Information provided by (Responsible Party):
ViiV Healthcare Identifier:
First received: March 16, 2011
Last updated: March 14, 2014
Last verified: March 2014
Results First Received: March 14, 2014  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Retrospective
Conditions: HIV

  Participant Flow

  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis population included all participants enrolled in the study.

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).

Baseline Measures
    All Participants  
Number of Participants  
[units: participants]
[units: years]
Median (Inter-Quartile Range)
  39   (32 to 46)  
[units: participants]
Female     2348  
Male     5854  

  Outcome Measures
  Show All 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
  Hide 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
  Hide 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
Study First Received: March 16, 2011
Results First Received: March 14, 2014
Last Updated: March 14, 2014
Health Authority: United States: Investigational Review Board