The RESPOND Outcomes study is a research study around use of antiretroviral and other relevant drugs and long-term clinical outcomes in patients living with HIV. Data collected in this study will be used to answer key unanswered questions regarding treatment of people living with HIV.
The specific objectives, falling into three main categories, are as follows: 1. Monitor the uptake of newer antiretroviral treatment (ART) drugs and drugs for treatment of co-infections and co-morbidities; 2. To evaluate the safety profiles of the newer individual ART drugs when used in routine clinical practice as part of either first-line or subsequent treatment regimens. 3. Investigate long term outcomes and clinical disease progression overall and in specific sub-groups The Outcomes study is a collaboration between investigators from clinics and cohorts across Europe, Australia and South America with a willingness to share data and to use a common follow-up schedule and assessment. Participating sites have a commitment to continue to follow this large cohort that is heterogeneous in both its demographic profile and in ART prescribing patterns thus resulting in enough power to answer many key clinical questions. The Outcomes study is a study in the RESPOND International Cohort Consortium of Infectious Diseases. RESPOND is an innovative, flexible and dynamic cohort consortium for the study of infectious diseases, including HIV, built as a generic structure for facilitating multi stakeholder involvement. In RESPOND all collected data is part of a common data repository or 'data lake', which is stored in a database located at CHIP, Rigshospitalet, Copenhagen, Denmark. Data collection in RESPOND is modular with a core data collection module onto which additional modules/studies can be added. Pseudonymised patient data can be entered manually via an online secure platform or be electronically transferred from existing local, regional or national data structures to the data lake. In the Outcomes study data will be collected at enrolment and at annual follow-up (FU) visits. For patients living with HIV-1 enrolled and under FU, demographic, laboratory, therapeutic and clinical data on HIV and viral hepatitis will be collected once a year. Clinical event data (except AIDS other than AIDS defining malignancies) will be collected in real-time on RESPOND event forms.
Study Type
OBSERVATIONAL
Enrollment
37,853
The Australian HIV Observational Database (AHOD)
Sydney, New South Wales, Australia
Proportion of HIV positive persons who initiate treatment with newer antiretroviral drugs
Proportion of HIV positive persons who initiate treatment with newer antiretroviral drugs and to describe changes over time in use of specific antiretroviral drugs in individual countries and diverse demographic groups
Time frame: From date of enrolment until the date of progression, lost to follow-up or death, whichever comes first, assessed up to 6 years
Proportion of HIV positive persons who initiate treatment of co-infections
Proportion of HIV positive persons who initiate treatment of co-infections and to describe changes over time in individual countries and diverse demographic groups
Time frame: From date of enrolment until the date of progression, lost to follow-up or death, whichever comes first, assessed up to 6 years
Proportion of HIV positive persons who initiate treatment of co-morbidities
Proportion of HIV positive persons who initiate treatment of co-morbidities and to describe changes over time in individual countries and diverse demographic groups
Time frame: From date of enrolment until the date of progression, lost to follow-up or death, whichever comes first, assessed up to 6 years
Monitor changes in plasma CD4+ T-lymphocyte counts among persons exposed to newer individual ARVs
Monitor changes in plasma CD4+ T-lymphocyte counts among persons exposed to newer individual ARVs
Time frame: From date of enrolment until the date of progression, lost to follow-up or death, whichever comes first, assessed up to 6 years
Monitor plasma HIV-RNA responses among persons exposed to newer individual ARVs
Monitor plasma HIV-RNA responses among persons exposed to newer individual ARVs
Time frame: From date of enrolment until the date of progression, lost to follow-up or death, whichever comes first, assessed up to 6 years
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Austrian HIV Cohort Study (AHIVCOS), Medizinische Universität Innsbruch
Innsbruck, Austria
RECRUITINGCHU Saint-Pierre Hospital
Brussels, Belgium
RECRUITINGRigshospitalet
Copenhagen, Denmark
RECRUITINGThe EuroSIDA Study, CHIP, Rigshospitalet
Copenhagen, Denmark
RECRUITINGNice HIV Cohort, Centre Hospitalier Universitaire de Nice
Nice, France
RECRUITINGGeorgian National AIDS Health Information System (AIDS HIS), IDACIRC
Tbilisi, Georgia
RECRUITINGUniversity Hospital Bonn
Bonn, Germany
RECRUITINGUniversity Hospital Cologne
Cologne, Germany
RECRUITINGFrankfurt HIV Cohort Study, Goethe-University Frankfurt
Frankfurt, Germany
RECRUITING...and 8 more locations
Evaluate the short- and long-term adverse effects of the newer ARVs when used in routine clinical practice
Evaluate the short- and long-term adverse effects of the newer ARVs when used in routine clinical practice as part of either first-line or subsequent treatment regimens, and whether adverse effects are reversible on discontinuation of the offending ARVs
Time frame: From date of enrolment until the date of progression, lost to follow-up or death, whichever comes first, assessed up to 6 years
Investigate if adverse effects are increased in some patient sub-groups in order to build clinical risk prediction scores to aid effective strategies for risk reduction
Investigate if adverse effects are increased in some patient sub-groups (e.g. those defined by age, gender, ethnicity, HIV-risk group, viral hepatitis- TB and other co-infections, ongoing viremia and across CD4 count strata) in order to build clinical risk prediction scores to aid effective strategies for risk reduction
Time frame: From date of enrolment until the date of progression, lost to follow-up or death, whichever comes first, assessed up to 6 years
Investigate if adverse effects are increased in some patient sub-groups in order to assess the risk and benefit for the individual
Investigate if adverse effects are increased in some patient sub-groups (e.g. those defined by age, gender, ethnicity, HIV-risk group, viral hepatitis- TB and other co-infections, ongoing viremia and across CD4 count strata) in order to assess the risk and benefit for the individual of any antiretroviral or group of antiretrovirals
Time frame: From date of enrolment until the date of progression, lost to follow-up or death, whichever comes first, assessed up to 6 years
Investigate long term clinical outcomes and clinical disease progression overall and in specific sub-groups
Investigate long term clinical outcomes and clinical disease progression overall and in specific sub-groups (e.g. those defined by age, gender, ethnicity, HIV-risk group, viral hepatitis- TB and other co-infections, ongoing viremia and across CD4 count strata)
Time frame: From date of enrolment until the date of progression, lost to follow-up or death, whichever comes first, assessed up to 6 years
Develop predictive risk-scores for the development of clinical outcomes to enable personalized decisions regarding risk and benefit of specific treatments in different demographic groups
After investigating long term clinical outcomes and clinical disease progression overall and in specific sub-groups (e.g. those defined by age, gender, ethnicity, HIV-risk group, viral hepatitis- TB and other co-infections, ongoing viremia and across CD4 count strata): to develop predictive risk-scores for the development and outcomes to enable personalized decisions regarding risk and benefit of specific treatments in different demographic groups
Time frame: From date of enrolment until the date of progression, lost to follow-up or death, whichever comes first, assessed up to 6 years