Status:
RECRUITING
The RESPOND Outcomes Study
Lead Sponsor:
Rigshospitalet, Denmark
Collaborating Sponsors:
Gilead Sciences
ViiV Healthcare
Conditions:
HIV
Eligibility:
All Genders
18+ years
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 u...
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-morbid...
Eligibility Criteria
Inclusion
- 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
- Persons receiving INSTI before 1/1/2012 are excluded from the Outcome study
- Persons aged \< 18 at baseline are excluded from the Outcome study
Key Trial Info
Start Date :
January 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
37853 Patients enrolled
Trial Details
Trial ID
NCT04090151
Start Date
January 1 2017
End Date
December 1 2025
Last Update
April 12 2024
Active Locations (18)
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1
The Australian HIV Observational Database (AHOD)
Sydney, New South Wales, Australia, 2052
2
Austrian HIV Cohort Study (AHIVCOS), Medizinische Universität Innsbruch
Innsbruck, Austria, 6020
3
CHU Saint-Pierre Hospital
Brussels, Belgium, 1000
4
Rigshospitalet
Copenhagen, Denmark, 2100