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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: 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
AIDS

  Participant Flow
  Hide 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
  Description
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  
COMPLETED     8202  
NOT COMPLETED     0  



  Baseline Characteristics
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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
  Description
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]
  8202  
Age  
[units: years]
Median ( Inter-Quartile Range )
  39  
  ( 32 to 46 )  
Gender  
[units: participants]
 
Female     2348  
Male     5854  



  Outcome Measures
  Hide All Outcome Measures

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

Measure Type Primary
Measure Title Incidence Rate of Malignancies
Measure Description Incidence rate of malignancies was calculated as the number of events divided by person-time. Only the first diagnosis of each event per participant was included. Person-time was calculated as the sum of all time contributed by each individual from the date of HIV care initiation at that institution or January 1, 2000 if in care prior to this date. Malignancies included acquired immunodeficiency syndrome (AIDS)-defining malignancies and non-AIDS defining malignancies. AIDS-defining malignancies included invasive cervical cancer, non-Hodgkin's lymphoma and kaposis sarcoma; non-AIDS defining malignancies included but not limited to Hodgkin’s disease, lung cancer, liver cancer, anal cancer, melanoma of the skin, leukemia, renal cancer, and prostate cancer. Overall data for non-AIDS defining malignancies and individual data for AIDS-defining malignancies was reported. Incidence rate was computed as the number of events per 100 person-years.
Time Frame Up to Week 626  
Safety Issue Yes  

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. Here, n=participants who were evaluable for this measure at given time points for each group, respectively.

Reporting Groups
  Description
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).

Measured Values
    All Participants  
Number of Participants Analyzed  
[units: participants]
  8202  
Incidence Rate of Malignancies  
[units: malignancies per 100 person-years]
Number ( 95% Confidence Interval )
 
Non-Hodgkin's lymphoma (n= 8202)     0.30  
  ( 0.24 to 0.36 )  
Kaposis sarcoma (n= 8202)     0.27  
  ( 0.22 to 0.34 )  
Invasive cervical cancer (n= 2348)     0.02  
  ( 0.002 to 0.07 )  
Non-AIDS-defining (n= 8202)     0.62  
  ( 0.54 to 0.72 )  

No statistical analysis provided for Incidence Rate of Malignancies



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

Measure Type Primary
Measure Title Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections
Measure Description Incidence rate of AIDS-defining opportunistic infections was calculated as the number of events divided by person-time. Only the first diagnosis of each event per participant was included. Person-time was calculated as the sum of all time contributed by each individual from the date of HIV care initiation at that institution or January 1, 2000 if in care prior to this date. Opportunistic infections were those that occurred on immune-compromised participants. AIDS-defining infections included: esophageal candidiasis; pneumocystes jiroveci; non-tuberculous mycobacterium infection; AIDS dementia complex; disseminated cryptococcosis; cytomegalovirus (all sites); wasting syndrome; toxoplasmosis; cytomegalovirus retinitis; mycobacterium tuberculosis; Progressive (Prog.) multifocal leukoencephalopathy; histoplasmosis; cryptosporidiosis; recurrent pneumonia; herpes simplex infection; extra-pulmonary coccidioidomycosis; salmonella septicemia; isosporiasis.
Time Frame Up to Week 626  
Safety Issue Yes  

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
  Description
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).

Measured Values
    All Participants  
Number of Participants Analyzed  
[units: participants]
  8202  
Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections  
[units: infections per 100 person-years]
Number ( 95% Confidence Interval )
 
Candida esophagitis     2.04  
  ( 1.88 to 2.20 )  
Pneumocystes jiroveci     1.72  
  ( 1.58 to 1.86 )  
Mycobacterium infection     0.77  
  ( 0.68 to 0.88 )  
AIDS dementia complex     0.66  
  ( 0.58 to 0.76 )  
Disseminated cryptococcosis     0.38  
  ( 0.31 to 0.45 )  
Cytomegalovirus     0.37  
  ( 0.31 to 0.44 )  
Wasting syndrome     0.28  
  ( 0.23 to 0.35 )  
Toxoplasmosis     0.25  
  ( 0.20 to 0.31 )  
Cytomegalovirus retinitis     0.22  
  ( 0.17 to 0.28 )  
Mycobacterium tuberculosis     0.20  
  ( 0.16 to 0.26 )  
Prog. multifocal leukoencephalopathy     0.16  
  ( 0.12 to 0.20 )  
Histoplasmosis     0.15  
  ( 0.11 to 0.19 )  
Cryptosporidiosis     0.13  
  ( 0.09 to 0.18 )  
Recurrent pneumonia     0.06  
  ( 0.04 to 0.10 )  
Herpes simplex virus     0.06  
  ( 0.03 to 0.09 )  
Extrapulmonary coccidiodomycosis     0.006  
  ( 0.00 to 0.02 )  
Salmonella septicemia     0  
  ( 0 to 0.01 )  
Isosporiasis     0  
  ( 0 to 0.01 )  

No statistical analysis provided for Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections



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

Measure Type Primary
Measure Title Incidence Rate of Myocardial Infarction
Measure Description Incidence rate of myocardial infarction (MI) was calculated as the number of events divided by person-time. Only first diagnosis of the event per participant was included. Person-time was calculated as the sum of all time contributed by each individual from the date of HIV care initiation at that institution or January 1, 2000 if in care prior to this date.
Time Frame Up to Week 626  
Safety Issue Yes  

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
  Description
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).

Measured Values
    All Participants  
Number of Participants Analyzed  
[units: participants]
  8202  
Incidence Rate of Myocardial Infarction  
[units: MI per 100 person-year]
Number ( 95% Confidence Interval )
  0.27  
  ( 0.21 to 0.33 )  

No statistical analysis provided for Incidence Rate of Myocardial Infarction



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

Measure Type Primary
Measure Title Incidence Rate of Liver Failure
Measure Description Incidence rate of liver failure was calculated as the number of events divided by person-time. Only first diagnosis of the event per participant was included. Person-time was calculated as the sum of all time contributed by each individual from the date of HIV care initiation at that institution or January 1, 2000 if in care prior to this date.
Time Frame Up to Week 626  
Safety Issue Yes  

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
  Description
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).

Measured Values
    All Participants  
Number of Participants Analyzed  
[units: participants]
  8202  
Incidence Rate of Liver Failure  
[units: liver failure per 100 person-years]
Number ( 95% Confidence Interval )
  0.16  
  ( 0.12 to 0.21 )  

No statistical analysis provided for Incidence Rate of Liver Failure



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

Measure Type Primary
Measure Title Incidence Rate of Viral Encephalitis
Measure Description Incidence rate of viral encephalitis was calculated as the number of events divided by person-time. Only first diagnosis of the event per participant was included. Person-time was calculated as the sum of all time contributed by each individual from the date of HIV care initiation at that institution or January 1, 2000 if in care prior to this date. Viral encephalitis was defined as inflammation of the brain due to virus.
Time Frame Up to Week 626  
Safety Issue Yes  

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
  Description
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).

Measured Values
    All Participants  
Number of Participants Analyzed  
[units: participants]
  8202  
Incidence Rate of Viral Encephalitis  
[units: viral encephalitis per 100 person-years]
Number ( 95% Confidence Interval )
  0.003  
  ( 0.00 to 0.02 )  

No statistical analysis provided for Incidence Rate of Viral Encephalitis



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

Measure Type Secondary
Measure Title Incidence Rate of Rhabdomyolysis
Measure Description Incidence rate of rhabdomyolysis was calculated as the number of events divided by person-time. Only first diagnosis of the event per participant was included. Person-time was calculated as the sum of all time contributed by each individual from the date of HIV care initiation at that institution or January 1, 2000 if in care prior to this date. Rhabdomyolysis was a condition of muscle fibers breakdown.
Time Frame Up to Week 626  
Safety Issue Yes  

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
  Description
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).

Measured Values
    All Participants  
Number of Participants Analyzed  
[units: participants]
  8202  
Incidence Rate of Rhabdomyolysis  
[units: rhabdomylosis per 100 person-years]
Number ( 95% Confidence Interval )
  0.10  
  ( 0.07 to 0.14 )  

No statistical analysis provided for Incidence Rate of Rhabdomyolysis



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

Measure Type Secondary
Measure Title Incidence Rate of Death
Measure Description Incidence rate of death was calculated as the number of events divided by person-time. Person-time was calculated as the sum of all time contributed by each individual from the date of HIV care initiation at that institution or January 1, 2000 if in care prior to this date. All-cause mortality was used for the analyses.
Time Frame Up to Week 626  
Safety Issue Yes  

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
  Description
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).

Measured Values
    All Participants  
Number of Participants Analyzed  
[units: participants]
  8202  
Incidence Rate of Death  
[units: death per 100 person-years]
Number ( 95% Confidence Interval )
  3.81  
  ( 3.60 to 4.02 )  

No statistical analysis provided for Incidence Rate of Death




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


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


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
Results First Received: March 14, 2014
Last Updated: March 14, 2014
Health Authority: United States: Investigational Review Board