Kaiser Permanente HIV Cohort Study
Sponsor
ViiV Healthcare (Industry)
Overall Status
Completed
CT.gov ID
NCT01339403
Collaborator
Kaiser Permanente (Other), Pfizer (Industry)
282,368
56
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Study Type:
Observational
Actual Enrollment
:
282368 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Hiv Infection, Antiretroviral Therapy Use And Other Predictors Of Selected Clinical Events In Kaiser Permanente
Study Start Date
:
Feb 1, 2009
Actual Primary Completion Date
:
Oct 1, 2013
Actual Study Completion Date
:
Oct 1, 2013
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| HIV infected No study specific intervention, non-interventional trial |
Other: non-interventional trial
No study specific intervention, non-interventional trial
|
| HIV-uninfected No study specific intervention, non-interventional trial |
Other: non-interventional trial
No study specific intervention, non-interventional trial
|
Outcome Measures
Primary Outcome Measures
- 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).
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
HIV infection.
Exclusion Criteria:
None
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- ViiV Healthcare
- Kaiser Permanente
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT01339403
Other Study ID Numbers:
- A4001105
First Posted:
Apr 20, 2011
Last Update Posted:
Apr 3, 2015
Last Verified:
Apr 1, 2015
Study Results
Participant Flow
| Recruitment Details | Participants infected and uninfected with Human Immunodeficiency Virus (HIV) were recruited and analyzed retrospectively in the Kaiser Permanente HIV registry. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Cohort 1: HIV Infected | Cohort 2: HIV Uninfected |
|---|---|---|
| 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 |
Baseline Characteristics
| Arm/Group Title | Cohort 1: HIV Infected | Cohort 2: HIV Uninfected | Total |
|---|---|---|---|
| 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 Participants | 24768 | 257600 | 282368 |
| Age, Customized (participants) [Number] | |||
| Less than (<) 35 years |
6883
27.8%
|
76826
29.8%
|
83709
29.6%
|
| Between 35 and 39 years |
4919
19.9%
|
50657
19.7%
|
55576
19.7%
|
| Between 40 and 44 years |
4700
19%
|
47564
18.5%
|
52264
18.5%
|
| Between 45 and 49 years |
3701
14.9%
|
37184
14.4%
|
40885
14.5%
|
| Between 50 and 54 years |
2302
9.3%
|
22942
8.9%
|
25244
8.9%
|
| Between 55 and 59 years |
1246
5%
|
12199
4.7%
|
13445
4.8%
|
| Between 60 and 64 years |
613
2.5%
|
6154
2.4%
|
6767
2.4%
|
| Greater than (>) 65 years |
404
1.6%
|
4074
1.6%
|
4478
1.6%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
2306
9.3%
|
24134
9.4%
|
26440
9.4%
|
| Male |
22462
90.7%
|
233466
90.6%
|
255928
90.6%
|
Outcome Measures
| Title | Incidence Rate of Malignancies |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis population included all participants enrolled in the study. |
| Arm/Group Title | Cohort 1: HIV Infected | Cohort 2: HIV Uninfected |
|---|---|---|
| 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). |
| Measure Participants | 24768 | 257600 |
| 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
|
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 | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Poisson Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Rate ratio |
| Estimated Value | 166.1 | |
| Confidence Interval |
(2-Sided) 95% 123.4 to 223.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
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 | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Poisson Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Rate ratio |
| Estimated Value | 12.1 | |
| Confidence Interval |
(2-Sided) 95% 10.3 to 14.2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
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 | ||
| Statistical Test of Hypothesis | p-Value | 0.059 |
| Comments | ||
| Method | Poisson Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Rate ratio |
| Estimated Value | 3.4 | |
| Confidence Interval |
(2-Sided) 95% 1.0 to 12.3 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
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 | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Poisson Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Rate ratio |
| Estimated Value | 1.7 | |
| Confidence Interval |
(2-Sided) 95% 1.5 to 1.8 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
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 | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Poisson Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Rate Ratio |
| Estimated Value | 166.1 | |
| Confidence Interval |
(2-Sided) 95% 123.4 to 223.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Incidence Rate of Myocardial Infarction and Ischemia |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis population included all participants enrolled in the study. |
| Arm/Group Title | Cohort 1: HIV Infected | Cohort 2: HIV Uninfected |
|---|---|---|
| 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). |
| Measure Participants | 24768 | 257600 |
| Number [CVS events per 100,000 person-years] |
435
|
313
|
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 | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Poisson Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Rate ratio |
| Estimated Value | 1.4 | |
| Confidence Interval |
(2-Sided) 95% 1.3 to 1.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis population included all participants enrolled in the study. |
| Arm/Group Title | Cohort 1: HIV Infected | Cohort 2: HIV Uninfected |
|---|---|---|
| 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). |
| Measure Participants | 24768 | 257600 |
| Wasting syndrome |
1002
|
15
|
| Pneumocystis jirovecii pneumonia |
760
|
2
|
| Recurrent pneumonia |
640
|
74
|
| Cytomegalovirus |
440
|
5
|
| HIV-related Encephalopathy |
405
|
NA
|
| 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
|
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 | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Poisson Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Rate ratio |
| Estimated Value | 65.7 | |
| Confidence Interval |
(2-Sided) 95% 57.1 to 75.7 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
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 | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Poisson Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Rate ratio |
| Estimated Value | 428.5 | |
| Confidence Interval |
(2-Sided) 95% 292.2 to 628.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
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 | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Poisson Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Rate ratio |
| Estimated Value | 8.7 | |
| Confidence Interval |
(2-Sided) 95% 7.9 to 9.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
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 | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Poisson Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Rate ratio |
| Estimated Value | 97.1 | |
| Confidence Interval |
(2-Sided) 95% 75.5 to 124.8 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
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 | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Poisson Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Rate ratio |
| Estimated Value | 60.2 | |
| Confidence Interval |
(2-Sided) 95% 48.3 to 74.9 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
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 | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Poisson Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Rate ratio |
| Estimated Value | 98.4 | |
| Confidence Interval |
(2-Sided) 95% 70.8 to 136.8 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
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 | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Poisson Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Rate ratio |
| Estimated Value | 189.5 | |
| Confidence Interval |
(2-Sided) 95% 112.3 to 319.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
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 | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Poisson Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Rate ratio |
| Estimated Value | 6.2 | |
| Confidence Interval |
(2-Sided) 95% 5.2 to 7.4 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
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 | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Poisson Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Rate ratio |
| Estimated Value | 594.5 | |
| Confidence Interval |
(2-Sided) 95% 146.5 to 2411.7 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
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 | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Poisson Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Rate ratio |
| Estimated Value | 10.6 | |
| Confidence Interval |
(2-Sided) 95% 7.8 to 14.4 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
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 | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Poisson Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Rate ratio |
| Estimated Value | 51.5 | |
| Confidence Interval |
(2-Sided) 95% 30.3 to 87.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
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 | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Poisson Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Rate ratio |
| Estimated Value | 6.2 | |
| Confidence Interval |
(2-Sided) 95% 3.0 to 12.9 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
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 | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | Poisson Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Rate ratio |
| Estimated Value | 13.0 | |
| Confidence Interval |
(2-Sided) 95% 7.4 to 23.1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Incidence Rate of Liver Failure |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis population included all participants enrolled in the study. |
| Arm/Group Title | Cohort 1: HIV Infected | Cohort 2: HIV Uninfected |
|---|---|---|
| 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). |
| Measure Participants | 24768 | 257600 |
| Number [liver failure per 100,000 person-years] |
492
|
105
|
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 | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Poisson Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Rate ratio |
| Estimated Value | 4.7 | |
| Confidence Interval |
(2-Sided) 95% 4.3 to 5.1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Incidence Rate of Liver Related Death |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis population included all participants enrolled in the study. |
| Arm/Group Title | Cohort 1: HIV Infected | Cohort 2: HIV Uninfected |
|---|---|---|
| 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). |
| Measure Participants | 24768 | 257600 |
| Number [death per 100,000 person-years] |
202
|
29
|
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 | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Poisson Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Rate ratio |
| Estimated Value | 7.0 | |
| Confidence Interval |
(2-Sided) 95% 6.0 to 8.2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Incidence Rate of Rhabdomyolysis |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis population included all participants enrolled in the study. |
| Arm/Group Title | Cohort 1: HIV Infected | Cohort 2: HIV Uninfected |
|---|---|---|
| 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). |
| Measure Participants | 24768 | 257600 |
| Number [rhabdomyolysis per 100,000 person-years] |
235
|
28
|
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 | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Poisson Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Rate ratio |
| Estimated Value | 8.3 | |
| Confidence Interval |
(2-Sided) 95% 7.1 to 9.6 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Incidence Rate of All-Cause Mortality |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis population included all participants enrolled in the study. |
| Arm/Group Title | Cohort 1: HIV Infected | Cohort 2: HIV Uninfected |
|---|---|---|
| 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). |
| Measure Participants | 24768 | 257600 |
| Number [death per 100,000 person-years] |
1827
|
326
|
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 | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Poisson Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Rate ratio |
| Estimated Value | 5.6 | |
| Confidence Interval |
(2-Sided) 95% 5.3 to 5.9 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Incidence Rate of Viral Encephalitis |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis population included all participants enrolled in the study. |
| Arm/Group Title | Cohort 1: HIV Infected | Cohort 2: HIV Uninfected |
|---|---|---|
| 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). |
| Measure Participants | 24768 | 257600 |
| Number [VE per 100,000 person-years] |
30
|
2
|
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 | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Poisson Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Rate ratio |
| Estimated Value | 19.8 | |
| Confidence Interval |
(2-Sided) 95% 11.2 to 35.2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| 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 | ||
| 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 (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Cohort 1: HIV Infected | Cohort 2: HIV Uninfected | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | 0/0 (NaN) | ||
Other (Not Including Serious) Adverse Events |
||||
| Cohort 1: HIV Infected | Cohort 2: HIV Uninfected | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | 0/0 (NaN) | ||
Limitations/Caveats
Designation of endpoints was based on study team's inputs, as the endpoints were not prioritized in the study protocol.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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
| Name/Title | Pfizer ClinicalTrials.gov Call Center |
|---|---|
| Organization | Pfizer, Inc. |
| Phone | 1-800-718-1021 |
| ClinicalTrials.gov_Inquiries@pfizer.com |
Responsible Party:
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT01339403
Other Study ID Numbers:
- A4001105
First Posted:
Apr 20, 2011
Last Update Posted:
Apr 3, 2015
Last Verified:
Apr 1, 2015