The RESPOND Outcomes Study

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04090151
• Other study ID #: The RESPOND Outcomes Study
• Status: Recruiting
• Start date: January 1, 2017
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: Rigshospitalet, Denmark
• Contact: Lars Peters, MD
• Phone: +45 35 45 57 64
• Email: lars.peters[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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-morbidities;

2. To evaluate the safety profiles of the newer individual ART drugs when used in routine clinical practice as part of either first-line or subsequent treatment regimens.

3. Investigate long term outcomes and clinical disease progression overall and in specific sub-groups

The Outcomes study is a collaboration between investigators from clinics and cohorts across Europe, Australia and South America with a willingness to share data and to use a common follow-up schedule and assessment. Participating sites have a commitment to continue to follow this large cohort that is heterogeneous in both its demographic profile and in ART prescribing patterns thus resulting in enough power to answer many key clinical questions.

The Outcomes study is a study in the RESPOND International Cohort Consortium of Infectious Diseases. RESPOND is an innovative, flexible and dynamic cohort consortium for the study of infectious diseases, including HIV, built as a generic structure for facilitating multi stakeholder involvement. In RESPOND all collected data is part of a common data repository or 'data lake', which is stored in a database located at CHIP, Rigshospitalet, Copenhagen, Denmark. Data collection in RESPOND is modular with a core data collection module onto which additional modules/studies can be added. Pseudonymised patient data can be entered manually via an online secure platform or be electronically transferred from existing local, regional or national data structures to the data lake.

In the Outcomes study data will be collected at enrolment and at annual follow-up (FU) visits. For patients living with HIV-1 enrolled and under FU, demographic, laboratory, therapeutic and clinical data on HIV and viral hepatitis will be collected once a year. Clinical event data (except AIDS other than AIDS defining malignancies) will be collected in real-time on RESPOND event forms.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 37853
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

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

Related Conditions & MeSH terms

• HIV

Locations

Country	Name	City	State
Australia	The Australian HIV Observational Database (AHOD)	Sydney	New South Wales
Austria	Austrian HIV Cohort Study (AHIVCOS), Medizinische Universität Innsbruch	Innsbruck
Belgium	CHU Saint-Pierre Hospital	Brussels
Denmark	Rigshospitalet	Copenhagen
Denmark	The EuroSIDA Study, CHIP, Rigshospitalet	Copenhagen
France	Nice HIV Cohort, Centre Hospitalier Universitaire de Nice	Nice
Georgia	Georgian National AIDS Health Information System (AIDS HIS), IDACIRC	Tbilisi
Germany	University Hospital Bonn	Bonn
Germany	University Hospital Cologne	Cologne
Germany	Frankfurt HIV Cohort Study, Goethe-University Frankfurt	Frankfurt
Italy	San Raffaele Scientific Institute, Ospedale San Raffaele	Milan
Italy	Italian Cohort Naive Antiretrovirals (ICONA)	Milano
Italy	Modena HIV Cohort, Università degli Studi di Modena	Modena
Netherlands	The ATHENA (AIDS Therapy Evaluation in the Netherlands) national observational HIV cohort, Stichting HIV Monitorin, AMC, University of Amsterdam	Amsterdam
Spain	PISCIS Cohort Study, Germans Trias i Pujol University Hospital	Badalona
Sweden	Swedish InfCare HIV Cohort, Karolinska University Hospital	Stockholm
Switzerland	Swiss HIV Cohort Study (SHCS), University Hospital Zurich	Zurich
United Kingdom	Royal Free HIV Cohort Study, Royal Free Hospital	London

Sponsors (3)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Gilead Sciences, ViiV Healthcare

Countries where clinical trial is conducted

Australia,  Austria,  Belgium,  Denmark,  France,  Georgia,  Germany,  Italy,  Netherlands,  Spain,  Sweden,  Switzerland,  United Kingdom, 

References & Publications (11)

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 — View Citation

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. — View Citation

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. — View Citation

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 person — View Citation

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 Tas — View Citation

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 developmen — View Citation

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: 1 — View Citation

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 — View Citation

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 — View Citation

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 amo — View Citation

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 immunode — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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

External Links

•   The RESPOND Study