The RESPOND Outcomes Study

NCT04090151 | Recruiting

• 1 other identifier: The RESPOND Outcomes Study
• Study Type: observational
• Target: 37,853
• Locations: 12 countries
• Sites: 17

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.

Conditions

HIV

Keywords

HIV; Prospective; Cohort; HCV

Outcome Measures

Primary Outcomes (10)

• 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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

Study Arms (17)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Gilead Sciences: collaborator
• ViiV Healthcare: collaborator

Study Sites (18)

The Australian HIV Observational Database (AHOD)

Sydney, New South Wales, 2052, Australia

RECRUITING

Austrian HIV Cohort Study (AHIVCOS), Medizinische Universität Innsbruch

Innsbruck, 6020, Austria

RECRUITING

CHU Saint-Pierre Hospital

Brussels, 1000, Belgium

RECRUITING

Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

The EuroSIDA Study, CHIP, Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

Nice HIV Cohort, Centre Hospitalier Universitaire de Nice

Nice, France

RECRUITING

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

Tbilisi, Georgia

RECRUITING

University Hospital Bonn

Bonn, 53105, Germany

RECRUITING

University Hospital Cologne

Cologne, 5093, Germany

RECRUITING

Frankfurt HIV Cohort Study, Goethe-University Frankfurt

Frankfurt, 60323, Germany

RECRUITING

San Raffaele Scientific Institute, Ospedale San Raffaele

Milan, Italy

RECRUITING

Italian Cohort Naive Antiretrovirals (ICONA)

Milan, 20124, Italy

RECRUITING

Modena HIV Cohort, Università degli Studi di Modena

Modena, 44100, Italy

RECRUITING

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

Amsterdam, 1105, Netherlands

RECRUITING

PISCIS Cohort Study, Germans Trias i Pujol University Hospital

Badalona, 08916, Spain

RECRUITING

Swedish InfCare HIV Cohort, Karolinska University Hospital

Stockholm, 171 76, Sweden

RECRUITING

Swiss HIV Cohort Study (SHCS), University Hospital Zurich

Zurich, 8091, Switzerland

RECRUITING

Royal Free HIV Cohort Study, Royal Free Hospital

London, NW3 2 PF, United Kingdom

RECRUITING

Related Publications (12)

• Obel N, Omland LH, Kronborg G, Larsen CS, Pedersen C, Pedersen G, Sorensen HT, Gerstoft J. Impact of non-HIV and HIV risk factors on survival in HIV-infected patients on HAART: a population-based nationwide cohort study. PLoS One. 2011;6(7):e22698. doi: 10.1371/journal.pone.0022698. Epub 2011 Jul 25.

  PMID: 21799935 RESULT

• Smith CJ, Ryom L, Weber R, Morlat P, Pradier C, Reiss P, Kowalska JD, de Wit S, Law M, el Sadr W, Kirk O, Friis-Moller N, Monforte Ad, Phillips AN, Sabin CA, Lundgren JD; D:A:D Study Group. Trends in underlying causes of death in people with HIV from 1999 to 2011 (D:A:D): a multicohort collaboration. Lancet. 2014 Jul 19;384(9939):241-8. doi: 10.1016/S0140-6736(14)60604-8.

  PMID: 25042234 RESULT

• Schouten J, Wit FW, Stolte IG, Kootstra NA, van der Valk M, Geerlings SE, Prins M, Reiss P; AGEhIV Cohort Study Group. Cross-sectional comparison of the prevalence of age-associated comorbidities and their risk factors between HIV-infected and uninfected individuals: the AGEhIV cohort study. Clin Infect Dis. 2014 Dec 15;59(12):1787-97. doi: 10.1093/cid/ciu701. Epub 2014 Sep 2.

  PMID: 25182245 RESULT

• Chary A, Nguyen NN, Maiton K, Holodniy M. A review of drug-drug interactions in older HIV-infected patients. Expert Rev Clin Pharmacol. 2017 Dec;10(12):1329-1352. doi: 10.1080/17512433.2017.1377610. Epub 2017 Sep 19.

  PMID: 28922979 RESULT

• Weber R, Sabin CA, Friis-Moller N, Reiss P, El-Sadr WM, Kirk O, Dabis F, Law MG, Pradier C, De Wit S, Akerlund B, Calvo G, Monforte Ad, Rickenbach M, Ledergerber B, Phillips AN, Lundgren JD. Liver-related deaths in persons infected with the human immunodeficiency virus: the D:A:D study. Arch Intern Med. 2006 Aug 14-28;166(15):1632-41. doi: 10.1001/archinte.166.15.1632.

  PMID: 16908797 RESULT

• Kattakuzhy S, Gross C, Emmanuel B, Teferi G, Jenkins V, Silk R, Akoth E, Thomas A, Ahmed C, Espinosa M, Price A, Rosenthal E, Tang L, Wilson E, Bentzen S, Masur H, Kottilil S; ASCEND Providers. Expansion of Treatment for Hepatitis C Virus Infection by Task Shifting to Community-Based Nonspecialist Providers: A Nonrandomized Clinical Trial. Ann Intern Med. 2017 Sep 5;167(5):311-318. doi: 10.7326/M17-0118. Epub 2017 Aug 8.

  PMID: 28785771 RESULT

• Falade-Nwulia O, Suarez-Cuervo C, Nelson DR, Fried MW, Segal JB, Sulkowski MS. Oral Direct-Acting Agent Therapy for Hepatitis C Virus Infection: A Systematic Review. Ann Intern Med. 2017 May 2;166(9):637-648. doi: 10.7326/M16-2575. Epub 2017 Mar 21.

  PMID: 28319996 RESULT

• van der Meer AJ, Veldt BJ, Feld JJ, Wedemeyer H, Dufour JF, Lammert F, Duarte-Rojo A, Heathcote EJ, Manns MP, Kuske L, Zeuzem S, Hofmann WP, de Knegt RJ, Hansen BE, Janssen HL. Association between sustained virological response and all-cause mortality among patients with chronic hepatitis C and advanced hepatic fibrosis. JAMA. 2012 Dec 26;308(24):2584-93. doi: 10.1001/jama.2012.144878.

  PMID: 23268517 RESULT

• Friis-Moller N, Ryom L, Smith C, Weber R, Reiss P, Dabis F, De Wit S, Monforte AD, Kirk O, Fontas E, Sabin C, Phillips A, Lundgren J, Law M; D:A:D study group. An updated prediction model of the global risk of cardiovascular disease in HIV-positive persons: The Data-collection on Adverse Effects of Anti-HIV Drugs (D:A:D) study. Eur J Prev Cardiol. 2016 Jan;23(2):214-23. doi: 10.1177/2047487315579291. Epub 2015 Apr 16.

  PMID: 25882821 RESULT

• Mocroft A, Lundgren JD, Ross M, Fux CA, Reiss P, Moranne O, Morlat P, Monforte Ad, Kirk O, Ryom L; Data Collection on Adverse events of Anti-HIV Drugs (D:A:D) Study. Cumulative and current exposure to potentially nephrotoxic antiretrovirals and development of chronic kidney disease in HIV-positive individuals with a normal baseline estimated glomerular filtration rate: a prospective international cohort study. Lancet HIV. 2016 Jan;3(1):e23-32. doi: 10.1016/S2352-3018(15)00211-8. Epub 2015 Nov 17.

  PMID: 26762990 RESULT

• Bruyand M, Ryom L, Shepherd L, Fatkenheuer G, Grulich A, Reiss P, de Wit S, D Arminio Monforte A, Furrer H, Pradier C, Lundgren J, Sabin C; D:A:D study group. Cancer risk and use of protease inhibitor or nonnucleoside reverse transcriptase inhibitor-based combination antiretroviral therapy: the D: A: D study. J Acquir Immune Defic Syndr. 2015 Apr 15;68(5):568-77. doi: 10.1097/QAI.0000000000000523.

  PMID: 25763785 RESULT

• Neesgaard B, Greenberg L, Miro JM, Grabmeier-Pfistershammer K, Wandeler G, Smith C, De Wit S, Wit F, Pelchen-Matthews A, Mussini C, Castagna A, Pradier C, d'Arminio Monforte A, Vehreschild JJ, Sonnerborg A, Anne AV, Carr A, Bansi-Matharu L, Lundgren JD, Garges H, Rogatto F, Zangerle R, Gunthard HF, Rasmussen LD, Necsoi C, van der Valk M, Menozzi M, Muccini C, Peters L, Mocroft A, Ryom L. Associations between integrase strand-transfer inhibitors and cardiovascular disease in people living with HIV: a multicentre prospective study from the RESPOND cohort consortium. Lancet HIV. 2022 Jul;9(7):e474-e485. doi: 10.1016/S2352-3018(22)00094-7. Epub 2022 Jun 7.

  PMID: 35688166 DERIVED

Related Links

• The RESPOND Study

Central Study Contacts

Lars Peters, MD

CONTACT

+45 35 45 57 64; lars.peters@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 8 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, DMSc Professor, Rigshospitalet & University of Copenhagen, Director, CHIP - Centre of Excellence for Health, Immunity and Infections

Study Record Dates

• First Submitted: August 30, 2019
• First Posted: September 16, 2019
• Study Start: January 1, 2017
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 12, 2024

Record last verified: 2024-04

Locations

BE (1); CH (1); DE (3); GB (1); IT (3); SE (1); FR (1); AU (1); DK (2); NL (1); GE (1); ES (1)