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

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ClinicalTrials.gov Identifier: NCT01339416
Recruitment Status : Completed
First Posted : April 20, 2011
Results First Posted : April 21, 2014
Last Update Posted : April 21, 2014
Sponsor:
Collaborators:
Johns Hopkins University
University of North Carolina, Chapel Hill
Vanderbilt University
Pfizer
Information provided by (Responsible Party):
ViiV Healthcare

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Retrospective
Conditions HIV
AIDS
Enrollment 8202
Recruitment Details 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  
Arm/Group Title All Participants
Hide Arm/Group Description 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).
Period Title: Overall Study
Started 8202
Completed 8202
Not Completed 0
Arm/Group Title All Participants
Hide Arm/Group Description 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).
Overall Number of Baseline Participants 8202
Hide Baseline Analysis Population Description
Analysis population included all participants enrolled in the study.
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 8202 participants
39
(32 to 46)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8202 participants
Female
2348
  28.6%
Male
5854
  71.4%
1.Primary Outcome
Title Incidence Rate of Malignancies
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title All Participants
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 8202
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: malignancies per 100 person-years
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)
2.Primary Outcome
Title Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants enrolled in the study.
Arm/Group Title All Participants
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 8202
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: infections per 100 person-years
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)
3.Primary Outcome
Title Incidence Rate of Myocardial Infarction
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants enrolled in the study.
Arm/Group Title All Participants
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 8202
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: MI per 100 person-year
0.27
(0.21 to 0.33)
4.Primary Outcome
Title Incidence Rate of Liver Failure
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants enrolled in the study.
Arm/Group Title All Participants
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 8202
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: liver failure per 100 person-years
0.16
(0.12 to 0.21)
5.Primary Outcome
Title Incidence Rate of Viral Encephalitis
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants enrolled in the study.
Arm/Group Title All Participants
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 8202
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: viral encephalitis per 100 person-years
0.003
(0.00 to 0.02)
6.Secondary Outcome
Title Incidence Rate of Rhabdomyolysis
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants enrolled in the study.
Arm/Group Title All Participants
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 8202
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: rhabdomylosis per 100 person-years
0.10
(0.07 to 0.14)
7.Secondary Outcome
Title Incidence Rate of Death
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants enrolled in the study.
Arm/Group Title All Participants
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 8202
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: death per 100 person-years
3.81
(3.60 to 4.02)
Time Frame [Not Specified]
Adverse Event Reporting Description Due to the retrospective observational nature of study individual adverse events (AEs) were not planned to be collected and reported but only the pre-defined AEs which are represented as clinical endpoints reported in the outcome measure section.
 
Arm/Group Title All Participants
Hide Arm/Group Description 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).
All-Cause Mortality
All Participants
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
All Participants
Affected / at Risk (%)
Total   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
All Participants
Affected / at Risk (%)
Total   0/0 
Designation of primary and secondary endpoints was based on study team's inputs, as the endpoints were not prioritized in the study protocol.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT01339416    
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