Trial Outcomes & Findings for HIV Cohort Study At Johns Hopkins University, University of North Carolina at Chapel Hill and Vanderbilt University (NCT NCT01339416)
NCT ID: NCT01339416
Last Updated: 2014-04-21
Results Overview
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.
COMPLETED
8202 participants
Up to Week 626
2014-04-21
Participant Flow
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).
Participant milestones
| Measure |
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).
|
|---|---|
|
Overall Study
STARTED
|
8202
|
|
Overall Study
COMPLETED
|
8202
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
HIV Cohort Study At Johns Hopkins University, University of North Carolina at Chapel Hill and Vanderbilt University
Baseline characteristics by cohort
| Measure |
All Participants
n=8202 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).
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|---|---|
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Age, Continuous
|
39 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2348 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5854 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Week 626Population: 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.
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.
Outcome measures
| Measure |
All Participants
n=8202 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).
|
|---|---|
|
Incidence Rate of Malignancies
Non-Hodgkin's lymphoma (n= 8202)
|
0.30 malignancies per 100 person-years
Interval 0.24 to 0.36
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Incidence Rate of Malignancies
Kaposis sarcoma (n= 8202)
|
0.27 malignancies per 100 person-years
Interval 0.22 to 0.34
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|
Incidence Rate of Malignancies
Invasive cervical cancer (n= 2348)
|
0.02 malignancies per 100 person-years
Interval 0.002 to 0.07
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|
Incidence Rate of Malignancies
Non-AIDS-defining (n= 8202)
|
0.62 malignancies per 100 person-years
Interval 0.54 to 0.72
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PRIMARY outcome
Timeframe: Up to Week 626Population: Analysis population included all participants enrolled in the study.
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.
Outcome measures
| Measure |
All Participants
n=8202 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).
|
|---|---|
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Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections
Candida esophagitis
|
2.04 infections per 100 person-years
Interval 1.88 to 2.2
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Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections
Pneumocystes jiroveci
|
1.72 infections per 100 person-years
Interval 1.58 to 1.86
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|
Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections
Mycobacterium infection
|
0.77 infections per 100 person-years
Interval 0.68 to 0.88
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|
Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections
AIDS dementia complex
|
0.66 infections per 100 person-years
Interval 0.58 to 0.76
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Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections
Disseminated cryptococcosis
|
0.38 infections per 100 person-years
Interval 0.31 to 0.45
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|
Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections
Cytomegalovirus
|
0.37 infections per 100 person-years
Interval 0.31 to 0.44
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|
Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections
Wasting syndrome
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0.28 infections per 100 person-years
Interval 0.23 to 0.35
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|
Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections
Toxoplasmosis
|
0.25 infections per 100 person-years
Interval 0.2 to 0.31
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|
Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections
Cytomegalovirus retinitis
|
0.22 infections per 100 person-years
Interval 0.17 to 0.28
|
|
Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections
Mycobacterium tuberculosis
|
0.20 infections per 100 person-years
Interval 0.16 to 0.26
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Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections
Prog. multifocal leukoencephalopathy
|
0.16 infections per 100 person-years
Interval 0.12 to 0.2
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Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections
Histoplasmosis
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0.15 infections per 100 person-years
Interval 0.11 to 0.19
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|
Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections
Cryptosporidiosis
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0.13 infections per 100 person-years
Interval 0.09 to 0.18
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|
Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections
Recurrent pneumonia
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0.06 infections per 100 person-years
Interval 0.04 to 0.1
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Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections
Herpes simplex virus
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0.06 infections per 100 person-years
Interval 0.03 to 0.09
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Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections
Extrapulmonary coccidiodomycosis
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0.006 infections per 100 person-years
Interval 0.0 to 0.02
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|
Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections
Salmonella septicemia
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0 infections per 100 person-years
Interval 0.0 to 0.01
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|
Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections
Isosporiasis
|
0 infections per 100 person-years
Interval 0.0 to 0.01
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PRIMARY outcome
Timeframe: Up to Week 626Population: Analysis population included all participants enrolled in the study.
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.
Outcome measures
| Measure |
All Participants
n=8202 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).
|
|---|---|
|
Incidence Rate of Myocardial Infarction
|
0.27 MI per 100 person-year
Interval 0.21 to 0.33
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PRIMARY outcome
Timeframe: Up to Week 626Population: Analysis population included all participants enrolled in the study.
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.
Outcome measures
| Measure |
All Participants
n=8202 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).
|
|---|---|
|
Incidence Rate of Liver Failure
|
0.16 liver failure per 100 person-years
Interval 0.12 to 0.21
|
PRIMARY outcome
Timeframe: Up to Week 626Population: Analysis population included all participants enrolled in the study.
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.
Outcome measures
| Measure |
All Participants
n=8202 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).
|
|---|---|
|
Incidence Rate of Viral Encephalitis
|
0.003 viral encephalitis per 100 person-years
Interval 0.0 to 0.02
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SECONDARY outcome
Timeframe: Up to Week 626Population: Analysis population included all participants enrolled in the study.
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.
Outcome measures
| Measure |
All Participants
n=8202 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).
|
|---|---|
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Incidence Rate of Rhabdomyolysis
|
0.10 rhabdomylosis per 100 person-years
Interval 0.07 to 0.14
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SECONDARY outcome
Timeframe: Up to Week 626Population: Analysis population included all participants enrolled in the study.
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.
Outcome measures
| Measure |
All Participants
n=8202 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).
|
|---|---|
|
Incidence Rate of Death
|
3.81 death per 100 person-years
Interval 3.6 to 4.02
|
Adverse Events
All Participants
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place