RecruitingNCT04090151

The RESPOND Outcomes Study

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

Sponsor

Rigshospitalet, Denmark

Enrollment

37,853 participants

Start Date

Jan 1, 2017

Study Type

OBSERVATIONAL

Conditions

HIV

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria6

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).

Exclusion Criteria2

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

Locations(18)

The Australian HIV Observational Database (AHOD)

Sydney, New South Wales, Australia

Austrian HIV Cohort Study (AHIVCOS), Medizinische Universität Innsbruch

Innsbruck, Austria

CHU Saint-Pierre Hospital

Brussels, Belgium

Rigshospitalet

Copenhagen, Denmark

The EuroSIDA Study, CHIP, Rigshospitalet

Copenhagen, Denmark

Nice HIV Cohort, Centre Hospitalier Universitaire de Nice

Nice, France

Georgian National AIDS Health Information System (AIDS HIS), IDACIRC

Tbilisi, Georgia

University Hospital Bonn

Bonn, Germany

University Hospital Cologne

Cologne, Germany

Frankfurt HIV Cohort Study, Goethe-University Frankfurt

Frankfurt, Germany

San Raffaele Scientific Institute, Ospedale San Raffaele

Milan, Italy

Italian Cohort Naive Antiretrovirals (ICONA)

Milan, Italy

Modena HIV Cohort, Università degli Studi di Modena

Modena, Italy

The ATHENA (AIDS Therapy Evaluation in the Netherlands) national observational HIV cohort, Stichting HIV Monitorin, AMC, University of Amsterdam

Amsterdam, Netherlands

PISCIS Cohort Study, Germans Trias i Pujol University Hospital

Badalona, Spain

Swedish InfCare HIV Cohort, Karolinska University Hospital

Stockholm, Sweden

Swiss HIV Cohort Study (SHCS), University Hospital Zurich

Zurich, Switzerland

Royal Free HIV Cohort Study, Royal Free Hospital

London, United Kingdom

View Full Details on ClinicalTrials.gov

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