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

This study has been completed.
Sponsor:
Collaborators:
Johns Hopkins University
University of North Carolina, Chapel Hill
Vanderbilt University
Pfizer
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT01339416
First received: March 16, 2011
Last updated: March 14, 2014
Last verified: March 2014

March 16, 2011
March 14, 2014
March 2009
May 2013   (final data collection date for primary outcome measure)
  • Incidence Rate of Malignancies [ Time Frame: Up to Week 626 ] [ Designated as safety issue: Yes ]
    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 Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections [ Time Frame: Up to Week 626 ] [ Designated as safety issue: Yes ]
    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 Myocardial Infarction [ Time Frame: Up to Week 626 ] [ Designated as safety issue: Yes ]
    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.
  • Incidence Rate of Liver Failure [ Time Frame: Up to Week 626 ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Up to Week 626 ] [ Designated as safety issue: Yes ]
    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 Myocardial infarction [ Time Frame: Median follow up of 3 years ] [ Designated as safety issue: Yes ]
  • Incidence rate of Liver failure [ Time Frame: Median follow up of 3 years ] [ Designated as safety issue: Yes ]
  • Incidence rate of Viral encephalitis [ Time Frame: Median follow up of 3 years ] [ Designated as safety issue: Yes ]
  • Incidence rate of Malignancies [ Time Frame: Median follow up of 3 years ] [ Designated as safety issue: Yes ]
  • Incidence rate of AIDS defining opportunistic infections [ Time Frame: Median follow up of 3 years ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01339416 on ClinicalTrials.gov Archive Site
  • Incidence Rate of Rhabdomyolysis [ Time Frame: Up to Week 626 ] [ Designated as safety issue: Yes ]
    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.
  • Incidence Rate of Death [ Time Frame: Up to Week 626 ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Median follow up of 3 years ] [ Designated as safety issue: Yes ]
  • Incidence rate of Death [ Time Frame: Median follow up of 3 years ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
HIV Cohort Study At Johns Hopkins University, University of North Carolina at Chapel Hill and Vanderbilt University
Clinical Adverse Events In HIV-Infected Patients

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.

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

Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

HIV infected patients seeking treatment at Johns Hopkins University, Vanderbilt University and University of North Carolina at Chapel Hill

  • HIV
  • AIDS
Not Provided
HIV infected cohort
HIV infected patients in the HIV cohorts at the three participating hospitals
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8202
May 2013
May 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • HIV infection.

Exclusion Criteria:

  • None.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01339416
A4001106
No
ViiV Healthcare
ViiV Healthcare
  • Johns Hopkins University
  • University of North Carolina, Chapel Hill
  • Vanderbilt University
  • Pfizer
Study Director: Pfizer CT.gov Call Center Pfizer
ViiV Healthcare
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP