The RESPOND Outcomes Study

Study Overview
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Brief Summary
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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.

Detailed Description
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The specific objectives, falling into three main categories, are as follows: Monitor the uptake of newer antiretroviral treatment (ART) drugs and drugs for treatment of co-infections and co-morbidities; 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. 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.

Official Title
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The RESPOND Outcomes Study - A Study in the RESPOND Consortium (RESPOND: International Cohort Consortium of Infectious Diseases)

Conditions
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HIV

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed Informed consent for the Outcomes study, if required by local/national legislation Signed informed consent for the RESPOND consortium and data repository, if required by local/national legislation Age ≥ 18 years of age Confirmed HIV-1 infection Persons receiving integrase inhibitor (INSTI) based antiretroviral therapy if have started after the later of 1/1/2012 and local cohort enrolment (i.e., during prospective follow-up in the cohort and after 1/1/2012) and have a CD4 and HIV viral load in the 12 months prior to starting INSTI or within 3 months after starting INSTI. ART experienced and ART naïve persons not receiving INSTI if have a CD4 and HIV viral load in the 12 months prior to baseline or within 3 months after baseline (here, the latest of 1/1/2012 or cohort enrolment). Persons lost to follow-up or who died before RESPOND enrolment should therefore still be included in the Outcomes study, provided they satisfy the other inclusion criteria. Exclusion Criteria: Persons receiving INSTI before 1/1/2012 are excluded from the Outcome study Persons aged < 18 at baseline are excluded from the Outcome study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Austrian HIV Cohort Study (AHIVCOS)<br> | |
| The Australian HIV Observational Database (AHOD)<br> | |
| CHU Saint-Pierre<br> | |
| University Hospital Cologne<br> | |
| The EuroSIDA cohort<br> | |
| Frankfurt HIV Cohort Study<br> | |
| Georgian National AIDS Health Information System (AIDS HIS)<br> | |
| Modena HIV Cohort<br> | |
| San Raffaele Scientific Institute<br> | |
| Swiss HIV Cohort Study (SHCS)<br> | |
| Royal Free HIV Cohort Study<br> | |
| The ATHENA national observational HIV cohort<br>ATHENA: AIDS Therapy Evaluation in the Netherlands | |
| Nice HIV Cohort<br> | |
| Italian Cohort Naive Antiretrovirals (ICONA)<br> | |
| PISCIS Cohort Study<br> | |
| Swedish InfCare HIV Cohort<br> | |
| Bonn University Hospital<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 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 | From date of enrolment until the date of progression, lost to follow-up or death, whichever comes first, assessed up to 6 years | 
| 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 | 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 | 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 | 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) | 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 | From date of enrolment until the date of progression, lost to follow-up or death, whichever comes first, assessed up to 6 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Prospective, Cohort, HCV