HIV Cohort Study At Johns Hopkins University, University of North Carolina at Chapel Hill and Vanderbilt University

• Sponsor: ViiV Healthcare (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01339416
• Collaborator: Johns Hopkins University (Other), University of North Carolina, Chapel Hill (Other), Vanderbilt University (Other), Pfizer (Industry)
• Enrollment: 8,202
• Duration (Months): 50

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV; AIDS

Detailed Description

All patients identified in the HIV registries will be included without any sampling

Study Design

• Study Type: Observational
• Actual Enrollment: 8202 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Clinical Adverse Events In HIV-Infected Patients
• Study Start Date: Mar 1, 2009
• Actual Primary Completion Date: May 1, 2013
• Actual Study Completion Date: May 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
HIV infected cohort HIV infected patients in the HIV cohorts at the three participating hospitals

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

Secondary Outcome Measures

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A 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
• Johns Hopkins University
• University of North Carolina, Chapel Hill
• Vanderbilt University
• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: ViiV Healthcare
• ClinicalTrials.gov Identifier: NCT01339416
• Other Study ID Numbers: A4001106
• First Posted: Apr 20, 2011
• Last Update Posted: Apr 21, 2014
• Last Verified: Mar 1, 2014

Study Results

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).

Arm/Group Title	All Participants
Arm/Group Description	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).
Period Title: Overall Study
STARTED	8202
COMPLETED	8202
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	All Participants
Arm/Group Description	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 Participants	8202
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	39
Sex: Female, Male (Count of Participants)
Female	2348 28.6%
Male	5854 71.4%

Outcome Measures

1. Primary Outcome

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 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

Outcome Measure Data

Analysis Population Description

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/Group Title	All Participants
Arm/Group Description	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).
Measure Participants	8202
Non-Hodgkin's lymphoma (n= 8202)	0.30
Kaposis sarcoma (n= 8202)	0.27
Invasive cervical cancer (n= 2348)	0.02
Non-AIDS-defining (n= 8202)	0.62

2. Primary Outcome

Title	Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections
Description	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

Outcome Measure Data

Analysis Population Description

Analysis population included all participants enrolled in the study.

Arm/Group Title	All Participants
Arm/Group Description	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).
Measure Participants	8202
Candida esophagitis	2.04
Pneumocystes jiroveci	1.72
Mycobacterium infection	0.77
AIDS dementia complex	0.66
Disseminated cryptococcosis	0.38
Cytomegalovirus	0.37
Wasting syndrome	0.28
Toxoplasmosis	0.25
Cytomegalovirus retinitis	0.22
Mycobacterium tuberculosis	0.20
Prog. multifocal leukoencephalopathy	0.16
Histoplasmosis	0.15
Cryptosporidiosis	0.13
Recurrent pneumonia	0.06
Herpes simplex virus	0.06
Extrapulmonary coccidiodomycosis	0.006
Salmonella septicemia	0
Isosporiasis	0

3. Primary Outcome

Title	Incidence Rate of Myocardial Infarction
Description	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

Outcome Measure Data

Analysis Population Description

Analysis population included all participants enrolled in the study.

Arm/Group Title	All Participants
Arm/Group Description	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).
Measure Participants	8202
Number (95% Confidence Interval) [MI per 100 person-year]	0.27

4. Primary Outcome

Title	Incidence Rate of Liver Failure
Description	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

Outcome Measure Data

Analysis Population Description

Analysis population included all participants enrolled in the study.

Arm/Group Title	All Participants
Arm/Group Description	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).
Measure Participants	8202
Number (95% Confidence Interval) [liver failure per 100 person-years]	0.16

5. Primary Outcome

Title	Incidence Rate of Viral Encephalitis
Description	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

Outcome Measure Data

Analysis Population Description

Analysis population included all participants enrolled in the study.

Arm/Group Title	All Participants
Arm/Group Description	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).
Measure Participants	8202
Number (95% Confidence Interval) [viral encephalitis per 100 person-years]	0.003

6. Secondary Outcome

Title	Incidence Rate of Rhabdomyolysis
Description	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

Outcome Measure Data

Analysis Population Description

Analysis population included all participants enrolled in the study.

Arm/Group Title	All Participants
Arm/Group Description	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).
Measure Participants	8202
Number (95% Confidence Interval) [rhabdomylosis per 100 person-years]	0.10

7. Secondary Outcome

Title	Incidence Rate of Death
Description	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

Outcome Measure Data

Analysis Population Description

Analysis population included all participants enrolled in the study.

Arm/Group Title	All Participants
Arm/Group Description	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).
Measure Participants	8202
Number (95% Confidence Interval) [death per 100 person-years]	3.81

Adverse Events

Adverse Event Reporting Description	Due to the retrospective observational nature of study individual adverse events (AEs) were not planned to be collected and reported but only the pre-defined AEs which are represented as clinical endpoints reported in the outcome measure section.
Arm/Group Title	All Participants
Arm/Group Description	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).
All Cause Mortality
	All Participants
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	All Participants
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	All Participants
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

Designation of primary and secondary endpoints was based on study team's inputs, as the endpoints were not prioritized in the study protocol.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.