AIDS, HIV
Conditions
Brief summary
Human Immunodeficiency Virus (HIV) infected patients in the HIV registries of Johns Hopkins University, University of North Carolina and Vanderbilt University will be followed in the routine clinical care to estimate the rates of prespecified clinical events in this population.
Detailed description
All patients identified in the HIV registries will be included without any sampling
Interventions
None listed
Sponsors
Johns Hopkins University
University of North Carolina, Chapel Hill
Vanderbilt University
Pfizer
ViiV Healthcare
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* HIV infection.
Exclusion criteria
* None.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections | Up to Week 626 | Incidence rate of AIDS-defining opportunistic infections was calculated as the number of events divided by person-time. Only the first diagnosis of each event per participant was included. Person-time was calculated as the sum of all time contributed by each individual from the date of HIV care initiation at that institution or January 1, 2000 if in care prior to this date. Opportunistic infections were those that occurred on immune-compromised participants. AIDS-defining infections included: esophageal candidiasis; pneumocystes jiroveci; non-tuberculous mycobacterium infection; AIDS dementia complex; disseminated cryptococcosis; cytomegalovirus (all sites); wasting syndrome; toxoplasmosis; cytomegalovirus retinitis; mycobacterium tuberculosis; Progressive (Prog.) multifocal leukoencephalopathy; histoplasmosis; cryptosporidiosis; recurrent pneumonia; herpes simplex infection; extra-pulmonary coccidioidomycosis; salmonella septicemia; isosporiasis. |
| Incidence Rate of Liver Failure | Up to Week 626 | Incidence rate of liver failure was calculated as the number of events divided by person-time. Only first diagnosis of the event per participant was included. Person-time was calculated as the sum of all time contributed by each individual from the date of HIV care initiation at that institution or January 1, 2000 if in care prior to this date. |
| Incidence Rate of Viral Encephalitis | Up to Week 626 | Incidence rate of viral encephalitis was calculated as the number of events divided by person-time. Only first diagnosis of the event per participant was included. Person-time was calculated as the sum of all time contributed by each individual from the date of HIV care initiation at that institution or January 1, 2000 if in care prior to this date. Viral encephalitis was defined as inflammation of the brain due to virus. |
| Incidence Rate of Malignancies | Up to Week 626 | Incidence rate of malignancies was calculated as the number of events divided by person-time. Only the first diagnosis of each event per participant was included. Person-time was calculated as the sum of all time contributed by each individual from the date of HIV care initiation at that institution or January 1, 2000 if in care prior to this date. Malignancies included acquired immunodeficiency syndrome (AIDS)-defining malignancies and non-AIDS defining malignancies. AIDS-defining malignancies included invasive cervical cancer, non-Hodgkin's lymphoma and kaposis sarcoma; non-AIDS defining malignancies included but not limited to Hodgkin's disease, lung cancer, liver cancer, anal cancer, melanoma of the skin, leukemia, renal cancer, and prostate cancer. Overall data for non-AIDS defining malignancies and individual data for AIDS-defining malignancies was reported. Incidence rate was computed as the number of events per 100 person-years. |
| Incidence Rate of Myocardial Infarction | Up to Week 626 | Incidence rate of myocardial infarction (MI) was calculated as the number of events divided by person-time. Only first diagnosis of the event per participant was included. Person-time was calculated as the sum of all time contributed by each individual from the date of HIV care initiation at that institution or January 1, 2000 if in care prior to this date. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence Rate of Death | Up to Week 626 | Incidence rate of death was calculated as the number of events divided by person-time. Person-time was calculated as the sum of all time contributed by each individual from the date of HIV care initiation at that institution or January 1, 2000 if in care prior to this date. All-cause mortality was used for the analyses. |
| Incidence Rate of Rhabdomyolysis | Up to Week 626 | Incidence rate of rhabdomyolysis was calculated as the number of events divided by person-time. Only first diagnosis of the event per participant was included. Person-time was calculated as the sum of all time contributed by each individual from the date of HIV care initiation at that institution or January 1, 2000 if in care prior to this date. Rhabdomyolysis was a condition of muscle fibers breakdown. |
Participant flow
Recruitment details
Participants were recruited and analyzed retrospectively from 3 clinical sites in the United States of America (Johns Hopkins University, University of North Carolina at Chapel Hill and Vanderbilt University).
Participants by arm
| Arm | Count |
|---|---|
| All Participants Participants who were diagnosed with Human immunodeficiency virus (HIV) infection and received HIV care during January 1, 2000 through December 31, 2010 (574 weeks) with follow-up extended up to 31st December 2011 (up to 626 weeks). | 8,202 |
| Total | 8,202 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 39 years |
| Sex: Female, Male Female | 2348 Participants |
| Sex: Female, Male Male | 5854 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections
Incidence rate of AIDS-defining opportunistic infections was calculated as the number of events divided by person-time. Only the first diagnosis of each event per participant was included. Person-time was calculated as the sum of all time contributed by each individual from the date of HIV care initiation at that institution or January 1, 2000 if in care prior to this date. Opportunistic infections were those that occurred on immune-compromised participants. AIDS-defining infections included: esophageal candidiasis; pneumocystes jiroveci; non-tuberculous mycobacterium infection; AIDS dementia complex; disseminated cryptococcosis; cytomegalovirus (all sites); wasting syndrome; toxoplasmosis; cytomegalovirus retinitis; mycobacterium tuberculosis; Progressive (Prog.) multifocal leukoencephalopathy; histoplasmosis; cryptosporidiosis; recurrent pneumonia; herpes simplex infection; extra-pulmonary coccidioidomycosis; salmonella septicemia; isosporiasis.
Time frame: Up to Week 626
Population: Analysis population included all participants enrolled in the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections | Pneumocystes jiroveci | 1.72 infections per 100 person-years |
| All Participants | Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections | Cytomegalovirus | 0.37 infections per 100 person-years |
| All Participants | Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections | Cryptosporidiosis | 0.13 infections per 100 person-years |
| All Participants | Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections | Candida esophagitis | 2.04 infections per 100 person-years |
| All Participants | Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections | Mycobacterium infection | 0.77 infections per 100 person-years |
| All Participants | Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections | AIDS dementia complex | 0.66 infections per 100 person-years |
| All Participants | Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections | Disseminated cryptococcosis | 0.38 infections per 100 person-years |
| All Participants | Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections | Wasting syndrome | 0.28 infections per 100 person-years |
| All Participants | Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections | Toxoplasmosis | 0.25 infections per 100 person-years |
| All Participants | Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections | Cytomegalovirus retinitis | 0.22 infections per 100 person-years |
| All Participants | Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections | Mycobacterium tuberculosis | 0.20 infections per 100 person-years |
| All Participants | Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections | Prog. multifocal leukoencephalopathy | 0.16 infections per 100 person-years |
| All Participants | Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections | Histoplasmosis | 0.15 infections per 100 person-years |
| All Participants | Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections | Recurrent pneumonia | 0.06 infections per 100 person-years |
| All Participants | Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections | Herpes simplex virus | 0.06 infections per 100 person-years |
| All Participants | Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections | Extrapulmonary coccidiodomycosis | 0.006 infections per 100 person-years |
| All Participants | Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections | Salmonella septicemia | 0 infections per 100 person-years |
| All Participants | Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections | Isosporiasis | 0 infections per 100 person-years |
Primary
Incidence Rate of Liver Failure
Incidence rate of liver failure was calculated as the number of events divided by person-time. Only first diagnosis of the event per participant was included. Person-time was calculated as the sum of all time contributed by each individual from the date of HIV care initiation at that institution or January 1, 2000 if in care prior to this date.
Time frame: Up to Week 626
Population: Analysis population included all participants enrolled in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Incidence Rate of Liver Failure | 0.16 liver failure per 100 person-years |
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 from the date of HIV care initiation at that institution or January 1, 2000 if in care prior to this date. Malignancies included acquired immunodeficiency syndrome (AIDS)-defining malignancies and non-AIDS defining malignancies. AIDS-defining malignancies included invasive cervical cancer, non-Hodgkin's lymphoma and kaposis sarcoma; non-AIDS defining malignancies included but not limited to Hodgkin's disease, lung cancer, liver cancer, anal cancer, melanoma of the skin, leukemia, renal cancer, and prostate cancer. Overall data for non-AIDS defining malignancies and individual data for AIDS-defining malignancies was reported. Incidence rate was computed as the number of events per 100 person-years.
Time frame: Up to Week 626
Population: Analysis population included all participants enrolled in the study. Here, n=participants who were evaluable for this measure at given time points for each group, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Incidence Rate of Malignancies | Kaposis sarcoma (n= 8202) | 0.27 malignancies per 100 person-years |
| All Participants | Incidence Rate of Malignancies | Invasive cervical cancer (n= 2348) | 0.02 malignancies per 100 person-years |
| All Participants | Incidence Rate of Malignancies | Non-Hodgkin's lymphoma (n= 8202) | 0.30 malignancies per 100 person-years |
| All Participants | Incidence Rate of Malignancies | Non-AIDS-defining (n= 8202) | 0.62 malignancies per 100 person-years |
Primary
Incidence Rate of Myocardial Infarction
Incidence rate of myocardial infarction (MI) was calculated as the number of events divided by person-time. Only first diagnosis of the event per participant was included. Person-time was calculated as the sum of all time contributed by each individual from the date of HIV care initiation at that institution or January 1, 2000 if in care prior to this date.
Time frame: Up to Week 626
Population: Analysis population included all participants enrolled in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Incidence Rate of Myocardial Infarction | 0.27 MI per 100 person-year |
Primary
Incidence Rate of Viral Encephalitis
Incidence rate of viral encephalitis was calculated as the number of events divided by person-time. Only first diagnosis of the event per participant was included. Person-time was calculated as the sum of all time contributed by each individual from the date of HIV care initiation at that institution or January 1, 2000 if in care prior to this date. Viral encephalitis was defined as inflammation of the brain due to virus.
Time frame: Up to Week 626
Population: Analysis population included all participants enrolled in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Incidence Rate of Viral Encephalitis | 0.003 viral encephalitis per 100 person-years |
Secondary
Incidence Rate of Death
Incidence rate of death was calculated as the number of events divided by person-time. Person-time was calculated as the sum of all time contributed by each individual from the date of HIV care initiation at that institution or January 1, 2000 if in care prior to this date. All-cause mortality was used for the analyses.
Time frame: Up to Week 626
Population: Analysis population included all participants enrolled in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Incidence Rate of Death | 3.81 death per 100 person-years |
Secondary
Incidence Rate of Rhabdomyolysis
Incidence rate of rhabdomyolysis was calculated as the number of events divided by person-time. Only first diagnosis of the event per participant was included. Person-time was calculated as the sum of all time contributed by each individual from the date of HIV care initiation at that institution or January 1, 2000 if in care prior to this date. Rhabdomyolysis was a condition of muscle fibers breakdown.
Time frame: Up to Week 626
Population: Analysis population included all participants enrolled in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Incidence Rate of Rhabdomyolysis | 0.10 rhabdomylosis per 100 person-years |