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Kaiser Permanente HIV Cohort Study

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.
 
ClinicalTrials.gov Identifier: NCT01339403
Recruitment Status : Completed
First Posted : April 20, 2011
Results First Posted : April 3, 2015
Last Update Posted : April 3, 2015
Sponsor:
Collaborators:
Kaiser Permanente
Pfizer
Information provided by (Responsible Party):
ViiV Healthcare

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Conditions HIV
AIDS
Intervention Other: non-interventional trial
Enrollment 282368
Recruitment Details Participants infected and uninfected with Human Immunodeficiency Virus (HIV) were recruited and analyzed retrospectively in the Kaiser Permanente HIV registry.
Pre-assignment Details  
Arm/Group Title Cohort 1: HIV Infected Cohort 2: HIV Uninfected
Hide Arm/Group Description Participants who were diagnosed with HIV infection and received HIV care during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks). Participants who were not diagnosed with HIV infection during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
Period Title: Overall Study
Started 24768 257600
Completed 24768 257600
Not Completed 0 0
Arm/Group Title Cohort 1: HIV Infected Cohort 2: HIV Uninfected Total
Hide Arm/Group Description Participants who were diagnosed with HIV infection and received HIV care during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks). Participants who were not diagnosed with HIV infection during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks). Total of all reporting groups
Overall Number of Baseline Participants 24768 257600 282368
Hide Baseline Analysis Population Description
Analysis population included all participants enrolled in the study.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 24768 participants 257600 participants 282368 participants
Less than (<) 35 years 6883 76826 83709
Between 35 and 39 years 4919 50657 55576
Between 40 and 44 years 4700 47564 52264
Between 45 and 49 years 3701 37184 40885
Between 50 and 54 years 2302 22942 25244
Between 55 and 59 years 1246 12199 13445
Between 60 and 64 years 613 6154 6767
Greater than (>) 65 years 404 4074 4478
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24768 participants 257600 participants 282368 participants
Female
2306
   9.3%
24134
   9.4%
26440
   9.4%
Male
22462
  90.7%
233466
  90.6%
255928
  90.6%
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 who were Kaiser Permanente (KP) member from the date of HIV care initiation at that institution or January 1, 1996 for KP Northern California(KPNC) and January 1, 2000 for KP Southern California(KPSC) 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,invasive non-Hodgkin's lymphoma and kaposi's sarcoma;non-AIDS defining malignancies cancers ascertained from the KP cancer registries.Overall data for non-AIDS and AIDS defining malignancies, along with individual data for AIDS-defining malignancies was reported. Incidence rate was computed as the number of events per 100,000 person-years.
Time Frame Up to Week 835
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants enrolled in the study.
Arm/Group Title Cohort 1: HIV Infected Cohort 2: HIV Uninfected
Hide Arm/Group Description:
Participants who were diagnosed with HIV infection and received HIV care during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
Participants who were not diagnosed with HIV infection during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
Overall Number of Participants Analyzed 24768 257600
Measure Type: Number
Unit of Measure: malignancies per 100,000 person-years
Kaposi's sarcoma 513 3
Invasive non-Hodgkin's lymphoma 238 20
Invasive cervical cancer 25 7
Non-AIDS-defining cancer 633 384
AIDS-defining cancer 740 23
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort 1: HIV Infected, Cohort 2: HIV Uninfected
Comments Kaposi's sarcoma: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Poisson Regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 166.1
Confidence Interval (2-Sided) 95%
123.4 to 223.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cohort 1: HIV Infected, Cohort 2: HIV Uninfected
Comments Invasive non-Hodgkin's lymphoma: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Poisson Regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 12.1
Confidence Interval (2-Sided) 95%
10.3 to 14.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Cohort 1: HIV Infected, Cohort 2: HIV Uninfected
Comments Invasive cervical cancer: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.059
Comments [Not Specified]
Method Poisson Regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 3.4
Confidence Interval (2-Sided) 95%
1.0 to 12.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Cohort 1: HIV Infected, Cohort 2: HIV Uninfected
Comments Non-AIDS-defining cancers: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Poisson Regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 1.7
Confidence Interval (2-Sided) 95%
1.5 to 1.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Cohort 1: HIV Infected, Cohort 2: HIV Uninfected
Comments AIDS-defining cancer: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Poisson Regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 166.1
Confidence Interval (2-Sided) 95%
123.4 to 223.5
Estimation Comments [Not Specified]
2.Primary Outcome
Title Incidence Rate of Myocardial Infarction and Ischemia
Hide Description Incidence rate of cardiovascular (CVS)events including myocardial infarction (MI) and ischemia 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 who were KP member from the date of HIV care initiation at that institution or January 1, 1996 for KPNC and January 1, 2000 for KPSC if in care prior to this date. Incidence rate was computed as the number of events per 100,000 person-years.
Time Frame Up to Week 835
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants enrolled in the study.
Arm/Group Title Cohort 1: HIV Infected Cohort 2: HIV Uninfected
Hide Arm/Group Description:
Participants who were diagnosed with HIV infection and received HIV care during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
Participants who were not diagnosed with HIV infection during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
Overall Number of Participants Analyzed 24768 257600
Measure Type: Number
Unit of Measure: CVS events per 100,000 person-years
435 313
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort 1: HIV Infected, Cohort 2: HIV Uninfected
Comments Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Poisson Regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 1.4
Confidence Interval (2-Sided) 95%
1.3 to 1.5
Estimation Comments [Not Specified]
3.Primary Outcome
Title Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections
Hide Description Incidence rate of AIDS-defining opportunistic infections (OI) 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 who were KP member from the date of HIV care initiation at that institution or January 1,1996 for KPNC and January 1,2000 for KPSC if in care prior to this date.OI were those that occurred on immune-compromised participants.AIDS-defining infections included:wasting syndrome;pneumocystis jirovecii pneumonia;recurrent pneumonia;cytomegalovirus;HIV-related encephalopathy;esophageal candidiasis;mycobacterium avium complex;cryptococcosis;mycobacterium tuberculosis;progressive multifocal leukoencephalopathy;lung candidiasis;toxoplasmosis of brain;coccidiomycosis;histoplasmosis;recurrent salmonella septicemia;chronic isosporiasis;cryptosporidiosis.Incidence rate was computed as the number of events per 100,000 person-years.
Time Frame Up to Week 835
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants enrolled in the study.
Arm/Group Title Cohort 1: HIV Infected Cohort 2: HIV Uninfected
Hide Arm/Group Description:
Participants who were diagnosed with HIV infection and received HIV care during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
Participants who were not diagnosed with HIV infection during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
Overall Number of Participants Analyzed 24768 257600
Measure Type: Number
Unit of Measure: infections per 100,000 person-years
Wasting syndrome 1002 15
Pneumocystis jirovecii pneumonia 760 2
Recurrent pneumonia 640 74
Cytomegalovirus 440 5
HIV-related Encephalopathy 405 NA [1] 
Esophageal Candidiasis 383 6
Mycobacterium avium complex 259 3
Cryptococcosis 187 1
Mycobacterium tuberculosis 157 25
Progressive multifocal leukoencephalopathy 78 0
Lung Candidiasis 63 6
Toxoplasmosis of brain 58 1
Coccidiomycosis 9 1
Histoplasmosis 20 2
Recurrent Salmonella septicemia 2 0
Chronic Isosporiasis 0 0
Cryptosporidiosis 72 0
[1]
No participant in this arm was evaluated for HIV-related encephalopathy, since only HIV infected participants were assessed for this infection.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort 1: HIV Infected, Cohort 2: HIV Uninfected
Comments Wasting syndrome: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Poisson Regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 65.7
Confidence Interval (2-Sided) 95%
57.1 to 75.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cohort 1: HIV Infected, Cohort 2: HIV Uninfected
Comments Pneumocystis jirovecii pneumonia: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Poisson Regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 428.5
Confidence Interval (2-Sided) 95%
292.2 to 628.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Cohort 1: HIV Infected, Cohort 2: HIV Uninfected
Comments Pneumonia, recurrent: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Poisson Regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 8.7
Confidence Interval (2-Sided) 95%
7.9 to 9.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Cohort 1: HIV Infected, Cohort 2: HIV Uninfected
Comments Cytomegalovirus: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Poisson Regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 97.1
Confidence Interval (2-Sided) 95%
75.5 to 124.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Cohort 1: HIV Infected, Cohort 2: HIV Uninfected
Comments Esophageal Candidiasis: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Poisson Regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 60.2
Confidence Interval (2-Sided) 95%
48.3 to 74.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Cohort 1: HIV Infected, Cohort 2: HIV Uninfected
Comments Mycobacterium avium complex: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Poisson Regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 98.4
Confidence Interval (2-Sided) 95%
70.8 to 136.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Cohort 1: HIV Infected, Cohort 2: HIV Uninfected
Comments Cryptococcosis: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Poisson Regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 189.5
Confidence Interval (2-Sided) 95%
112.3 to 319.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Cohort 1: HIV Infected, Cohort 2: HIV Uninfected
Comments Mycobacterium tuberculosis: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Poisson Regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 6.2
Confidence Interval (2-Sided) 95%
5.2 to 7.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Cohort 1: HIV Infected, Cohort 2: HIV Uninfected
Comments Progressive multifocal leukoencephalopathy: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Poisson Regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 594.5
Confidence Interval (2-Sided) 95%
146.5 to 2411.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Cohort 1: HIV Infected, Cohort 2: HIV Uninfected
Comments Lung Candidiasis: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Poisson Regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 10.6
Confidence Interval (2-Sided) 95%
7.8 to 14.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Cohort 1: HIV Infected, Cohort 2: HIV Uninfected
Comments Toxoplasmosis of brain: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Poisson Regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 51.5
Confidence Interval (2-Sided) 95%
30.3 to 87.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Cohort 1: HIV Infected, Cohort 2: HIV Uninfected
Comments Coccidiomycosis: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Poisson Regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 6.2
Confidence Interval (2-Sided) 95%
3.0 to 12.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Cohort 1: HIV Infected, Cohort 2: HIV Uninfected
Comments Histoplasmosis: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Poisson Regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 13.0
Confidence Interval (2-Sided) 95%
7.4 to 23.1
Estimation Comments [Not Specified]
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 the first diagnosis of each event per participant was included. Person-time was calculated as the sum of all time contributed by each individual who were KP member from the date of HIV care initiation at that institution or January 1, 1996 for KPNC and January 1, 2000 for KPSC if in care prior to this date. Incidence rate was computed as the number of events per 100,000 person-years.
Time Frame Up to Week 835
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants enrolled in the study.
Arm/Group Title Cohort 1: HIV Infected Cohort 2: HIV Uninfected
Hide Arm/Group Description:
Participants who were diagnosed with HIV infection and received HIV care during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
Participants who were not diagnosed with HIV infection during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
Overall Number of Participants Analyzed 24768 257600
Measure Type: Number
Unit of Measure: liver failure per 100,000 person-years
492 105
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort 1: HIV Infected, Cohort 2: HIV Uninfected
Comments Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Poisson Regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 4.7
Confidence Interval (2-Sided) 95%
4.3 to 5.1
Estimation Comments [Not Specified]
5.Primary Outcome
Title Incidence Rate of Liver Related Death
Hide Description Incidence rate of liver related death 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 who were KP member from the date of HIV care initiation at that institution or January 1, 1996 for KPNC and January 1, 2000 for KPSC if in care prior to this date. Incidence rate was computed as the number of events per 100,000 person-years.
Time Frame Up to Week 835
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants enrolled in the study.
Arm/Group Title Cohort 1: HIV Infected Cohort 2: HIV Uninfected
Hide Arm/Group Description:
Participants who were diagnosed with HIV infection and received HIV care during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
Participants who were not diagnosed with HIV infection during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
Overall Number of Participants Analyzed 24768 257600
Measure Type: Number
Unit of Measure: death per 100,000 person-years
202 29
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort 1: HIV Infected, Cohort 2: HIV Uninfected
Comments Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Poisson Regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 7.0
Confidence Interval (2-Sided) 95%
6.0 to 8.2
Estimation Comments [Not Specified]
6.Primary Outcome
Title Incidence Rate of Rhabdomyolysis
Hide Description Incidence rate of Rhabdomyolysis 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 who were KP member from the date of HIV care initiation at that institution or January 1, 1996 for KPNC and January 1, 2000 for KPSC if in care prior to this date. Incidence rate was computed as the number of events per 100,000 person-years.
Time Frame Up to Week 835
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants enrolled in the study.
Arm/Group Title Cohort 1: HIV Infected Cohort 2: HIV Uninfected
Hide Arm/Group Description:
Participants who were diagnosed with HIV infection and received HIV care during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
Participants who were not diagnosed with HIV infection during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
Overall Number of Participants Analyzed 24768 257600
Measure Type: Number
Unit of Measure: rhabdomyolysis per 100,000 person-years
235 28
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort 1: HIV Infected, Cohort 2: HIV Uninfected
Comments Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Poisson Regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 8.3
Confidence Interval (2-Sided) 95%
7.1 to 9.6
Estimation Comments [Not Specified]
7.Primary Outcome
Title Incidence Rate of All-Cause Mortality
Hide Description Incidence rate of all-cause mortality 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 who were KP member from the date of HIV care initiation at that institution or January 1, 1996 for KPNC and January 1, 2000 for KPSC if in care prior to this date. Incidence rate was computed as the number of events per 100,000 person-years.
Time Frame Up to Week 835
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants enrolled in the study.
Arm/Group Title Cohort 1: HIV Infected Cohort 2: HIV Uninfected
Hide Arm/Group Description:
Participants who were diagnosed with HIV infection and received HIV care during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
Participants who were not diagnosed with HIV infection during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
Overall Number of Participants Analyzed 24768 257600
Measure Type: Number
Unit of Measure: death per 100,000 person-years
1827 326
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort 1: HIV Infected, Cohort 2: HIV Uninfected
Comments Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Poisson Regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 5.6
Confidence Interval (2-Sided) 95%
5.3 to 5.9
Estimation Comments [Not Specified]
8.Primary Outcome
Title Incidence Rate of Viral Encephalitis
Hide Description Incidence rate of viral encephalitis (VE) 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 who were KP member from the date of HIV care initiation at that institution or January 1, 1996 for KPNC and January 1, 2000 for KPSC if in care prior to this date. Incidence rate was computed as the number of events per 100,000 person-years. The participants with viral encephalitis were followed-up up to 31st December 2009 (730 Weeks).
Time Frame Up to Week 730
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants enrolled in the study.
Arm/Group Title Cohort 1: HIV Infected Cohort 2: HIV Uninfected
Hide Arm/Group Description:
Participants who were diagnosed with HIV infection and received HIV care during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
Participants who were not diagnosed with HIV infection during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
Overall Number of Participants Analyzed 24768 257600
Measure Type: Number
Unit of Measure: VE per 100,000 person-years
30 2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort 1: HIV Infected, Cohort 2: HIV Uninfected
Comments Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Poisson Regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 19.8
Confidence Interval (2-Sided) 95%
11.2 to 35.2
Estimation Comments [Not Specified]
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.
 
Arm/Group Title Cohort 1: HIV Infected Cohort 2: HIV Uninfected
Hide Arm/Group Description Participants who were diagnosed with HIV infection and received HIV care during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks). Participants who were not diagnosed with HIV infection during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
All-Cause Mortality
Cohort 1: HIV Infected Cohort 2: HIV Uninfected
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Cohort 1: HIV Infected Cohort 2: HIV Uninfected
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cohort 1: HIV Infected Cohort 2: HIV Uninfected
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Designation of endpoints was based on study team's inputs, as the endpoints were not prioritized in the study protocol.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
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: NCT01339403    
Other Study ID Numbers: A4001105
First Submitted: March 16, 2011
First Posted: April 20, 2011
Results First Submitted: October 27, 2014
Results First Posted: April 3, 2015
Last Update Posted: April 3, 2015