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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04090151




Registration number
NCT04090151
Ethics application status
Date submitted
30/08/2019
Date registered
16/09/2019
Date last updated
19/09/2019

Titles & IDs
Public title
The RESPOND Outcomes Study
Scientific title
The RESPOND Outcomes Study - A Study in the RESPOND Consortium (RESPOND: International Cohort Consortium of Infectious Diseases)
Secondary ID [1] 0 0
The RESPOND Outcomes Study
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
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 -

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
From date of enrolment until the date of progression, lost to follow-up or death, whichever comes first, assessed up to 6 years
Primary outcome [2] 0 0
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
Timepoint [2] 0 0
From date of enrolment until the date of progression, lost to follow-up or death, whichever comes first, assessed up to 6 years
Primary outcome [3] 0 0
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
Timepoint [3] 0 0
From date of enrolment until the date of progression, lost to follow-up or death, whichever comes first, assessed up to 6 years
Primary outcome [4] 0 0
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
Timepoint [4] 0 0
From date of enrolment until the date of progression, lost to follow-up or death, whichever comes first, assessed up to 6 years
Primary outcome [5] 0 0
Monitor plasma HIV-RNA responses among persons exposed to newer individual ARVs - Monitor plasma HIV-RNA responses among persons exposed to newer individual ARVs
Timepoint [5] 0 0
From date of enrolment until the date of progression, lost to follow-up or death, whichever comes first, assessed up to 6 years
Primary outcome [6] 0 0
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
Timepoint [6] 0 0
From date of enrolment until the date of progression, lost to follow-up or death, whichever comes first, assessed up to 6 years
Primary outcome [7] 0 0
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
Timepoint [7] 0 0
From date of enrolment until the date of progression, lost to follow-up or death, whichever comes first, assessed up to 6 years
Primary outcome [8] 0 0
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
Timepoint [8] 0 0
From date of enrolment until the date of progression, lost to follow-up or death, whichever comes first, assessed up to 6 years
Primary outcome [9] 0 0
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)
Timepoint [9] 0 0
From date of enrolment until the date of progression, lost to follow-up or death, whichever comes first, assessed up to 6 years
Primary outcome [10] 0 0
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
Timepoint [10] 0 0
From date of enrolment until the date of progression, lost to follow-up or death, whichever comes first, assessed up to 6 years

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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
The Australian HIV Observational Database (AHOD) - Sydney
Recruitment postcode(s) [1] 0 0
2052 - Sydney
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Innsbruck
Country [2] 0 0
Belgium
State/province [2] 0 0
Brussels
Country [3] 0 0
Denmark
State/province [3] 0 0
Copenhagen
Country [4] 0 0
France
State/province [4] 0 0
Nice
Country [5] 0 0
Georgia
State/province [5] 0 0
Tbilisi
Country [6] 0 0
Germany
State/province [6] 0 0
Bonn
Country [7] 0 0
Germany
State/province [7] 0 0
Cologne
Country [8] 0 0
Germany
State/province [8] 0 0
Frankfurt
Country [9] 0 0
Italy
State/province [9] 0 0
Milano
Country [10] 0 0
Italy
State/province [10] 0 0
Milan
Country [11] 0 0
Italy
State/province [11] 0 0
Modena
Country [12] 0 0
Netherlands
State/province [12] 0 0
Amsterdam
Country [13] 0 0
Spain
State/province [13] 0 0
Badalona
Country [14] 0 0
Sweden
State/province [14] 0 0
Stockholm
Country [15] 0 0
Switzerland
State/province [15] 0 0
Zurich
Country [16] 0 0
United Kingdom
State/province [16] 0 0
London

Funding & Sponsors
Primary sponsor type
Other
Name
Rigshospitalet, Denmark
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Gilead Sciences
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
ViiV Healthcare
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT04090151
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Lars Peters, MD
Address 0 0
Country 0 0
Phone 0 0
+45 35 45 57 64
Fax 0 0
Email 0 0
lars.peters@regionh.dk
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04090151