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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04090151
Ethics application status
Date submitted
30/08/2019
Date registered
16/09/2019
Date last updated
12/04/2024

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
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
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
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
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
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
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
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
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
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
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
Sex
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
1/01/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
37853
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/study/NCT04090151
Trial related presentations / publications
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
[email protected]
Contact person for scientific queries



Summary Results

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