The RESPOND Outcomes Study

April 10, 2024 updated by: Jens D Lundgren, MD, Rigshospitalet, Denmark

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

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

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 (Estimated)

37853

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2052
        • Recruiting
        • The Australian HIV Observational Database (AHOD)
        • Contact:
        • Principal Investigator:
          • Matthew Law, Professor
  • Austria
      • Innsbruck, Austria, 6020
        • Recruiting
        • Austrian HIV Cohort Study (AHIVCOS), Medizinische Universität Innsbruch
        • Contact:
        • Principal Investigator:
          • Robert Zangerle, MD
  • Belgium
  • Denmark
      • Copenhagen, Denmark, 2100
        • Recruiting
        • Rigshospitalet
        • Contact:
          • Lars Peters, MD
      • Copenhagen, Denmark, 2100
        • Recruiting
        • The EuroSIDA Study, CHIP, Rigshospitalet
        • Contact:
        • Principal Investigator:
          • Gilles Wandeler, MD
  • France
      • Nice, France
        • Recruiting
        • Nice HIV Cohort, Centre Hospitalier Universitaire de Nice
        • Contact:
        • Principal Investigator:
          • Christian Pradier, Prof
  • Georgia
      • Tbilisi, Georgia
        • Recruiting
        • Georgian National AIDS Health Information System (AIDS HIS), IDACIRC
        • Contact:
        • Principal Investigator:
          • Nikoloz Chkhartishvili, MD
  • Germany
      • Bonn, Germany, 53105
        • Recruiting
        • University Hospital Bonn
        • Contact:
          • Jan-Christian Wasmuth, MD
        • Principal Investigator:
          • Jan-Christian Wasmuth, MD
      • Cologne, Germany, 5093
        • Recruiting
        • University Hospital Cologne
        • Contact:
        • Principal Investigator:
          • Jörg Janne Vehreschild, Prog
      • Frankfurt, Germany, 60323
        • Recruiting
        • Frankfurt HIV Cohort Study, Goethe-University Frankfurt
        • Contact:
        • Principal Investigator:
          • Christoph Stephan
  • Italy
      • Milan, Italy
        • Recruiting
        • San Raffaele Scientific Institute, Ospedale San Raffaele
        • Contact:
        • Principal Investigator:
          • Adriano Lazzarin, Prof
        • Principal Investigator:
          • Antonella Castagna, Prof
      • Milano, Italy, 20124
        • Recruiting
        • Italian Cohort Naive Antiretrovirals (ICONA)
        • Principal Investigator:
          • Antonella d'Arminio Monforte, Prof
        • Contact:
      • Modena, Italy, 44100
        • Recruiting
        • Modena HIV Cohort, Università degli Studi di Modena
        • Contact:
          • Cristina Mussini, MD
        • Contact:
          • crimuss@unimore.it
        • Principal Investigator:
          • Cristina Mussini, MD
  • Netherlands
      • Amsterdam, Netherlands, 1105
        • Recruiting
        • The ATHENA (AIDS Therapy Evaluation in the Netherlands) national observational HIV cohort, Stichting HIV Monitorin, AMC, University of Amsterdam
        • Contact:
        • Principal Investigator:
          • Ferdinand Wit, MD
  • Spain
      • Badalona, Spain, 08916
        • Recruiting
        • PISCIS Cohort Study, Germans Trias i Pujol University Hospital
        • Contact:
        • Principal Investigator:
          • Jordi Casabona, MD
        • Principal Investigator:
          • Josep Miró, Prof
  • Sweden
      • Stockholm, Sweden, 171 76
        • Recruiting
        • Swedish InfCare HIV Cohort, Karolinska University Hospital
        • Contact:
        • Principal Investigator:
          • ANDERS Sönnerborg, Prof
  • Switzerland
      • Zurich, Switzerland, 8091
        • Recruiting
        • Swiss HIV Cohort Study (SHCS), University Hospital Zurich
        • Contact:
        • Principal Investigator:
          • Huldrych Günthard, MD
  • United Kingdom
      • London, United Kingdom, NW3 2 PF
        • Recruiting
        • Royal Free HIV Cohort Study, Royal Free Hospital
        • Contact:
        • Principal Investigator:
          • Colette Smith, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participating clinics will enrol eligible persons living with HIV. Some clinics will enrol all their eligible persons living with HIV, and others will enrol a random sample.

Description

Inclusion Criteria:

  1. Signed Informed consent for the Outcomes study, if required by local/national legislation
  2. Signed informed consent for the RESPOND consortium and data repository, if required by local/national legislation
  3. Age ≥ 18 years of age
  4. Confirmed HIV-1 infection
  5. 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.
  6. 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).
  7. 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:

  1. Persons receiving INSTI before 1/1/2012 are excluded from the Outcome study
  2. Persons aged < 18 at baseline are excluded from the Outcome study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of HIV positive persons who initiate treatment with newer antiretroviral drugs
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 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
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 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
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 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
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
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
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
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
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
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
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 (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
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 (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
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 (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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Collaborators

Gilead Sciences
ViiV Healthcare

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

August 30, 2019

First Submitted That Met QC Criteria

September 11, 2019

First Posted (Actual)

September 16, 2019

Study Record Updates

Last Update Posted (Actual)

April 12, 2024

Last Update Submitted That Met QC Criteria

April 10, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • The RESPOND Outcomes Study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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