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| Name | Class |
|---|---|
| Kaiser Permanente | OTHER |
| Pfizer | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIV infected | No study specific intervention, non-interventional trial |
| |
| HIV-uninfected | No study specific intervention, non-interventional trial |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| non-interventional trial | Other | No study specific intervention, non-interventional trial |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to Week 835 |
| 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. | Up to Week 835 |
| 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. |
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Inclusion Criteria:
HIV infection.
Exclusion Criteria:
None
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HIV infected patients in the HIV Registry of Kasier Permanente Northern and Southern California and a matched cohort of non-HIV infected patients in Kaiser Permanente
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Participants infected and uninfected with Human Immunodeficiency Virus (HIV) were recruited and analyzed retrospectively in the Kaiser Permanente HIV registry.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Analysis population included all participants enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 | Cohort 2: HIV Uninfected |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Analysis population included all participants enrolled in the study. | Posted | Number | malignancies per 100,000 person-years | Up to Week 835 |
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Due to the retrospective observational nature of study individual adverse events (AEs) were not planned to be collected and reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
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Designation of endpoints was based on study team's inputs, as the endpoints were not prioritized in the study protocol.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| non-interventional trial |
| Other |
No study specific intervention, non-interventional trial |
|
| Up to Week 835 |
| 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. | Up to Week 835 |
| 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. | Up to Week 835 |
| 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. | Up to Week 835 |
| 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. | Up to Week 835 |
| 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). | Up to Week 730 |
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). |
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | 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). |
| OG001 | 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). |
|
|
|
| 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. | Analysis population included all participants enrolled in the study. | Posted | Number | CVS events per 100,000 person-years | Up to Week 835 |
|
|
|
|
| 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. | Analysis population included all participants enrolled in the study. | Posted | Number | infections per 100,000 person-years | Up to Week 835 |
|
|
|
|
| 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. | Analysis population included all participants enrolled in the study. | Posted | Number | liver failure per 100,000 person-years | Up to Week 835 |
|
|
|
|
| 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. | Analysis population included all participants enrolled in the study. | Posted | Number | death per 100,000 person-years | Up to Week 835 |
|
|
|
|
| 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. | Analysis population included all participants enrolled in the study. | Posted | Number | rhabdomyolysis per 100,000 person-years | Up to Week 835 |
|
|
|
|
| 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. | Analysis population included all participants enrolled in the study. | Posted | Number | death per 100,000 person-years | Up to Week 835 |
|
|
|
|
| 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). | Analysis population included all participants enrolled in the study. | Posted | Number | VE per 100,000 person-years | Up to Week 730 |
|
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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). | 0 | 0 | 0 | 0 |
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.
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| 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 |
|
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.
| Poisson Regression |
| <0.001 |
| Rate ratio |
| 428.5 |
| 2-Sided |
| 95 |
| 292.2 |
| 628.5 |
| No |
| Superiority or Other |
| 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. | Poisson Regression | <0.001 | Rate ratio | 8.7 | 2-Sided | 95 | 7.9 | 9.5 | No | Superiority or Other |
| 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. | Poisson Regression | <0.001 | Rate ratio | 97.1 | 2-Sided | 95 | 75.5 | 124.8 | No | Superiority or Other |
| 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. | Poisson Regression | <0.001 | Rate ratio | 60.2 | 2-Sided | 95 | 48.3 | 74.9 | No | Superiority or Other |
| 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. | Poisson Regression | <0.001 | Rate ratio | 98.4 | 2-Sided | 95 | 70.8 | 136.8 | No | Superiority or Other |
| 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. | Poisson Regression | <0.001 | Rate ratio | 189.5 | 2-Sided | 95 | 112.3 | 319.5 | No | Superiority or Other |
| 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. | Poisson Regression | <0.001 | Rate ratio | 6.2 | 2-Sided | 95 | 5.2 | 7.4 | No | Superiority or Other |
| 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. | Poisson Regression | <0.001 | Rate ratio | 594.5 | 2-Sided | 95 | 146.5 | 2411.7 | No | Superiority or Other |
| 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. | Poisson Regression | <0.001 | Rate ratio | 10.6 | 2-Sided | 95 | 7.8 | 14.4 | No | Superiority or Other |
| 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. | Poisson Regression | <0.001 | Rate ratio | 51.5 | 2-Sided | 95 | 30.3 | 87.5 | No | Superiority or Other |
| 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. | Poisson Regression | <0.001 | Rate ratio | 6.2 | 2-Sided | 95 | 3.0 | 12.9 | No | Superiority or Other |
| 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. | Poisson Regression | <0.0001 | Rate ratio | 13.0 | 2-Sided | 95 | 7.4 | 23.1 | No | Superiority or Other |