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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04090151
Registration number
NCT04090151
Ethics application status
Date submitted
30/08/2019
Date registered
16/09/2019
Date last updated
12/04/2024
Titles & IDs
Public title
The RESPOND Outcomes Study
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Scientific title
The RESPOND Outcomes Study - A Study in the RESPOND Consortium (RESPOND: International Cohort Consortium of Infectious Diseases)
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Secondary ID [1]
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The RESPOND Outcomes Study
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
HIV
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Condition category
Condition code
Intervention/exposure
Study type
Observational [Patient Registry]
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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 -
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Proportion of HIV positive persons who initiate treatment with newer antiretroviral drugs
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Assessment method [1]
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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
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Timepoint [1]
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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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Primary outcome [2]
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Proportion of HIV positive persons who initiate treatment of co-infections
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Assessment method [2]
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Proportion of HIV positive persons who initiate treatment of co-infections and to describe changes over time in individual countries and diverse demographic groups
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Timepoint [2]
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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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Primary outcome [3]
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Proportion of HIV positive persons who initiate treatment of co-morbidities
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Assessment method [3]
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Proportion of HIV positive persons who initiate treatment of co-morbidities and to describe changes over time in individual countries and diverse demographic groups
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Timepoint [3]
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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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Primary outcome [4]
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Monitor changes in plasma CD4+ T-lymphocyte counts among persons exposed to newer individual ARVs
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Assessment method [4]
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Monitor changes in plasma CD4+ T-lymphocyte counts among persons exposed to newer individual ARVs
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Timepoint [4]
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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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Primary outcome [5]
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Monitor plasma HIV-RNA responses among persons exposed to newer individual ARVs
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Assessment method [5]
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Monitor plasma HIV-RNA responses among persons exposed to newer individual ARVs
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Timepoint [5]
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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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Primary outcome [6]
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Evaluate the short- and long-term adverse effects of the newer ARVs when used in routine clinical practice
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Assessment method [6]
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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
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Timepoint [6]
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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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Primary outcome [7]
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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
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Assessment method [7]
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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
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Timepoint [7]
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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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Primary outcome [8]
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Investigate if adverse effects are increased in some patient sub-groups in order to assess the risk and benefit for the individual
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Assessment method [8]
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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
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Timepoint [8]
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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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Primary outcome [9]
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Investigate long term clinical outcomes and clinical disease progression overall and in specific sub-groups
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Assessment method [9]
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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)
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Timepoint [9]
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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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Primary outcome [10]
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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
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Assessment method [10]
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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
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Timepoint [10]
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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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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2025
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Actual
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Sample size
Target
37853
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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The Australian HIV Observational Database (AHOD) - Sydney
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Recruitment postcode(s) [1]
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2052 - Sydney
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Recruitment outside Australia
Country [1]
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Austria
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State/province [1]
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Innsbruck
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Country [2]
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Belgium
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State/province [2]
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Brussels
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Country [3]
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Denmark
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State/province [3]
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Copenhagen
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Country [4]
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France
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State/province [4]
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Nice
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Country [5]
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Georgia
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State/province [5]
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Tbilisi
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Country [6]
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Germany
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State/province [6]
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Bonn
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Country [7]
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Germany
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State/province [7]
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Cologne
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Country [8]
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Germany
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State/province [8]
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Frankfurt
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Country [9]
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Italy
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State/province [9]
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Milano
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Country [10]
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Italy
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State/province [10]
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Milan
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Country [11]
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Italy
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State/province [11]
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Modena
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Country [12]
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Netherlands
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State/province [12]
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Amsterdam
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Country [13]
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Spain
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State/province [13]
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Badalona
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Country [14]
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Sweden
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State/province [14]
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Stockholm
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Country [15]
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Switzerland
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State/province [15]
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Zurich
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Country [16]
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United Kingdom
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State/province [16]
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London
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Funding & Sponsors
Primary sponsor type
Other
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Name
Rigshospitalet, Denmark
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Address
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Gilead Sciences
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Address [1]
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Country [1]
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Other collaborator category [2]
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Commercial sector/Industry
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Name [2]
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ViiV Healthcare
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04090151
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Lars Peters, MD
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Address
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Country
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Phone
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+45 35 45 57 64
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04090151
Download to PDF