AIDS, HIV
Conditions
Brief summary
Human Immunodeficiency Virus (HIV) infected patients in the Kaiser Permanente HIV registry wil be followed in the usual clinical care to estimate the rates of specified clinical events. The rates will be stratified by relevant characteristics like age, CD4 counts, HIV Viral Load (VL), HIV medication history. The rates in the HIV infected cohort wil be compared with the rates of these events in patients in the Kaiser Permanente database who are not infected with HIV.
Detailed description
All HIV infected patients in the database will be included without any sampling. A random sample of non-HIV infected patients will be included as comparator.
Interventions
No study specific intervention, non-interventional trial
Sponsors
Kaiser Permanente
Pfizer
ViiV Healthcare
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
HIV infection.
Exclusion criteria
None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence Rate of Malignancies | Up to Week 835 | 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. |
| Incidence Rate of Myocardial Infarction and Ischemia | Up to Week 835 | 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. |
| Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections | Up to Week 835 | 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. |
| Incidence Rate of Liver Failure | Up to Week 835 | 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. |
| Incidence Rate of Liver Related Death | Up to Week 835 | 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. |
| Incidence Rate of Rhabdomyolysis | Up to Week 835 | 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. |
| Incidence Rate of All-Cause Mortality | Up to Week 835 | 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. |
| Incidence Rate of Viral Encephalitis | Up to Week 730 | 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). |
Participant flow
Recruitment details
Participants infected and uninfected with Human Immunodeficiency Virus (HIV) were recruited and analyzed retrospectively in the Kaiser Permanente HIV registry.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1: HIV Infected 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). | 24,768 |
| Cohort 2: HIV Uninfected 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). | 257,600 |
| Total | 282,368 |
Baseline characteristics
| Characteristic | Cohort 1: HIV Infected | Total | Cohort 2: HIV Uninfected |
|---|---|---|---|
| Age, Customized Between 35 and 39 years | 4919 participants | 55576 participants | 50657 participants |
| Age, Customized Between 40 and 44 years | 4700 participants | 52264 participants | 47564 participants |
| Age, Customized Between 45 and 49 years | 3701 participants | 40885 participants | 37184 participants |
| Age, Customized Between 50 and 54 years | 2302 participants | 25244 participants | 22942 participants |
| Age, Customized Between 55 and 59 years | 1246 participants | 13445 participants | 12199 participants |
| Age, Customized Between 60 and 64 years | 613 participants | 6767 participants | 6154 participants |
| Age, Customized Greater than (>) 65 years | 404 participants | 4478 participants | 4074 participants |
| Age, Customized Less than (<) 35 years | 6883 participants | 83709 participants | 76826 participants |
| Sex: Female, Male Female | 2306 Participants | 26440 Participants | 24134 Participants |
| Sex: Female, Male Male | 22462 Participants | 255928 Participants | 233466 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections
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
Population: Analysis population included all participants enrolled in the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1: HIV Infected | Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections | Recurrent pneumonia | 640 infections per 100,000 person-years |
| Cohort 1: HIV Infected | Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections | Progressive multifocal leukoencephalopathy | 78 infections per 100,000 person-years |
| Cohort 1: HIV Infected | Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections | Wasting syndrome | 1002 infections per 100,000 person-years |
| Cohort 1: HIV Infected | Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections | Lung Candidiasis | 63 infections per 100,000 person-years |
| Cohort 1: HIV Infected | Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections | Pneumocystis jirovecii pneumonia | 760 infections per 100,000 person-years |
| Cohort 1: HIV Infected | Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections | Toxoplasmosis of brain | 58 infections per 100,000 person-years |
| Cohort 1: HIV Infected | Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections | HIV-related Encephalopathy | 405 infections per 100,000 person-years |
| Cohort 1: HIV Infected | Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections | Coccidiomycosis | 9 infections per 100,000 person-years |
| Cohort 1: HIV Infected | Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections | Esophageal Candidiasis | 383 infections per 100,000 person-years |
| Cohort 1: HIV Infected | Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections | Histoplasmosis | 20 infections per 100,000 person-years |
| Cohort 1: HIV Infected | Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections | Cytomegalovirus | 440 infections per 100,000 person-years |
| Cohort 1: HIV Infected | Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections | Recurrent Salmonella septicemia | 2 infections per 100,000 person-years |
| Cohort 1: HIV Infected | Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections | Mycobacterium avium complex | 259 infections per 100,000 person-years |
| Cohort 1: HIV Infected | Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections | Chronic Isosporiasis | 0 infections per 100,000 person-years |
| Cohort 1: HIV Infected | Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections | Cryptococcosis | 187 infections per 100,000 person-years |
| Cohort 1: HIV Infected | Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections | Cryptosporidiosis | 72 infections per 100,000 person-years |
| Cohort 1: HIV Infected | Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections | Mycobacterium tuberculosis | 157 infections per 100,000 person-years |
| Cohort 2: HIV Uninfected | Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections | Cryptosporidiosis | 0 infections per 100,000 person-years |
| Cohort 2: HIV Uninfected | Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections | Pneumocystis jirovecii pneumonia | 2 infections per 100,000 person-years |
| Cohort 2: HIV Uninfected | Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections | Cytomegalovirus | 5 infections per 100,000 person-years |
| Cohort 2: HIV Uninfected | Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections | HIV-related Encephalopathy | NA infections per 100,000 person-years |
| Cohort 2: HIV Uninfected | Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections | Cryptococcosis | 1 infections per 100,000 person-years |
| Cohort 2: HIV Uninfected | Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections | Recurrent pneumonia | 74 infections per 100,000 person-years |
| Cohort 2: HIV Uninfected | Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections | Esophageal Candidiasis | 6 infections per 100,000 person-years |
| Cohort 2: HIV Uninfected | Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections | Mycobacterium avium complex | 3 infections per 100,000 person-years |
| Cohort 2: HIV Uninfected | Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections | Mycobacterium tuberculosis | 25 infections per 100,000 person-years |
| Cohort 2: HIV Uninfected | Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections | Progressive multifocal leukoencephalopathy | 0 infections per 100,000 person-years |
| Cohort 2: HIV Uninfected | Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections | Lung Candidiasis | 6 infections per 100,000 person-years |
| Cohort 2: HIV Uninfected | Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections | Toxoplasmosis of brain | 1 infections per 100,000 person-years |
| Cohort 2: HIV Uninfected | Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections | Coccidiomycosis | 1 infections per 100,000 person-years |
| Cohort 2: HIV Uninfected | Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections | Histoplasmosis | 2 infections per 100,000 person-years |
| Cohort 2: HIV Uninfected | Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections | Recurrent Salmonella septicemia | 0 infections per 100,000 person-years |
| Cohort 2: HIV Uninfected | Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections | Chronic Isosporiasis | 0 infections per 100,000 person-years |
| Cohort 2: HIV Uninfected | Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections | Wasting syndrome | 15 infections per 100,000 person-years |
Comparison: 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.p-value: <0.00195% CI: [57.1, 75.7]Poisson Regression
Comparison: 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.p-value: <0.00195% CI: [292.2, 628.5]Poisson Regression
Comparison: 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.p-value: <0.00195% CI: [7.9, 9.5]Poisson Regression
Comparison: 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.p-value: <0.00195% CI: [75.5, 124.8]Poisson Regression
Comparison: 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.p-value: <0.00195% CI: [48.3, 74.9]Poisson Regression
Comparison: 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.p-value: <0.00195% CI: [70.8, 136.8]Poisson Regression
Comparison: 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.p-value: <0.00195% CI: [112.3, 319.5]Poisson Regression
Comparison: 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.p-value: <0.00195% CI: [5.2, 7.4]Poisson Regression
Comparison: 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.p-value: <0.00195% CI: [146.5, 2411.7]Poisson Regression
Comparison: 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.p-value: <0.00195% CI: [7.8, 14.4]Poisson Regression
Comparison: 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.p-value: <0.00195% CI: [30.3, 87.5]Poisson Regression
Comparison: 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.p-value: <0.00195% CI: [3, 12.9]Poisson Regression
Comparison: 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.p-value: <0.000195% CI: [7.4, 23.1]Poisson Regression
Primary
Incidence Rate of All-Cause Mortality
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
Population: Analysis population included all participants enrolled in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: HIV Infected | Incidence Rate of All-Cause Mortality | 1827 death per 100,000 person-years |
| Cohort 2: HIV Uninfected | Incidence Rate of All-Cause Mortality | 326 death per 100,000 person-years |
Comparison: 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.p-value: <0.00195% CI: [5.3, 5.9]Poisson Regression
Primary
Incidence Rate of Liver Failure
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
Population: Analysis population included all participants enrolled in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: HIV Infected | Incidence Rate of Liver Failure | 492 liver failure per 100,000 person-years |
| Cohort 2: HIV Uninfected | Incidence Rate of Liver Failure | 105 liver failure per 100,000 person-years |
Comparison: 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.p-value: <0.00195% CI: [4.3, 5.1]Poisson Regression
Primary
Incidence Rate of Liver Related Death
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
Population: Analysis population included all participants enrolled in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: HIV Infected | Incidence Rate of Liver Related Death | 202 death per 100,000 person-years |
| Cohort 2: HIV Uninfected | Incidence Rate of Liver Related Death | 29 death per 100,000 person-years |
Comparison: 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.p-value: <0.00195% CI: [6, 8.2]Poisson Regression
Primary
Incidence Rate of Malignancies
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
Population: Analysis population included all participants enrolled in the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1: HIV Infected | Incidence Rate of Malignancies | Invasive non-Hodgkin's lymphoma | 238 malignancies per 100,000 person-years |
| Cohort 1: HIV Infected | Incidence Rate of Malignancies | Kaposi's sarcoma | 513 malignancies per 100,000 person-years |
| Cohort 1: HIV Infected | Incidence Rate of Malignancies | Invasive cervical cancer | 25 malignancies per 100,000 person-years |
| Cohort 1: HIV Infected | Incidence Rate of Malignancies | Non-AIDS-defining cancer | 633 malignancies per 100,000 person-years |
| Cohort 1: HIV Infected | Incidence Rate of Malignancies | AIDS-defining cancer | 740 malignancies per 100,000 person-years |
| Cohort 2: HIV Uninfected | Incidence Rate of Malignancies | Kaposi's sarcoma | 3 malignancies per 100,000 person-years |
| Cohort 2: HIV Uninfected | Incidence Rate of Malignancies | Invasive non-Hodgkin's lymphoma | 20 malignancies per 100,000 person-years |
| Cohort 2: HIV Uninfected | Incidence Rate of Malignancies | Invasive cervical cancer | 7 malignancies per 100,000 person-years |
| Cohort 2: HIV Uninfected | Incidence Rate of Malignancies | AIDS-defining cancer | 23 malignancies per 100,000 person-years |
| Cohort 2: HIV Uninfected | Incidence Rate of Malignancies | Non-AIDS-defining cancer | 384 malignancies per 100,000 person-years |
Comparison: 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.p-value: <0.00195% CI: [123.4, 223.5]Poisson Regression
Comparison: 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.p-value: <0.00195% CI: [10.3, 14.2]Poisson Regression
Comparison: 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.p-value: 0.05995% CI: [1, 12.3]Poisson Regression
Comparison: 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.p-value: <0.00195% CI: [1.5, 1.8]Poisson Regression
Comparison: 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.p-value: <0.00195% CI: [123.4, 223.5]Poisson Regression
Primary
Incidence Rate of Myocardial Infarction and Ischemia
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
Population: Analysis population included all participants enrolled in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: HIV Infected | Incidence Rate of Myocardial Infarction and Ischemia | 435 CVS events per 100,000 person-years |
| Cohort 2: HIV Uninfected | Incidence Rate of Myocardial Infarction and Ischemia | 313 CVS events per 100,000 person-years |
Comparison: 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.p-value: <0.00195% CI: [1.3, 1.5]Poisson Regression
Primary
Incidence Rate of Rhabdomyolysis
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
Population: Analysis population included all participants enrolled in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: HIV Infected | Incidence Rate of Rhabdomyolysis | 235 rhabdomyolysis per 100,000 person-years |
| Cohort 2: HIV Uninfected | Incidence Rate of Rhabdomyolysis | 28 rhabdomyolysis per 100,000 person-years |
Comparison: 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.p-value: <0.00195% CI: [7.1, 9.6]Poisson Regression
Primary
Incidence Rate of Viral Encephalitis
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
Population: Analysis population included all participants enrolled in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: HIV Infected | Incidence Rate of Viral Encephalitis | 30 VE per 100,000 person-years |
| Cohort 2: HIV Uninfected | Incidence Rate of Viral Encephalitis | 2 VE per 100,000 person-years |
Comparison: 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.p-value: <0.00195% CI: [11.2, 35.2]Poisson Regression