Primary and Secondary Drug Resistance Mutations (DRMs) in HIV As a Risk Factor of Failure of ART, Including Two Drugs Based Regimens.

NCT06661317 | Not Yet Recruiting

• 1 other identifier: Primary and secondary HIV DRMs
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The presence of drug resistance mutations (DRMs) in HIV plays an important role in ART effectiveness. Despite very good results of ART, there is constant concern about the emergence of HIV strains with DRMs, what may lead to virological suppression failure. The concerns grow especially among patients treated with two drugs based regimens, including long acting therapies in injections (LAI ART) or regimens used in preexposure prophylaxis (PreP).

Conditions

HIV-1-infection; DRM; DRM Gene Mutation; ART

Keywords

HIV; drug resistance mutations; DRM; LAI; ART; integrase inhibitors

Outcome Measures

Primary Outcomes (1)

• frequency of DRMs

  frequency of DRMs in all included patients

  2 years

Secondary Outcomes (1)

• frequency of primary and secondary DRMs

  2 years

Study Arms (2)

primary DRMs

patients with the presence of primary DRMs

Other: no intervention

secondary DRMs

patients with the presence of secondary DRMs

Other: no intervention

Interventions

no intervention OTHER

no intervention

primary DRMs; secondary DRMs

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

HIV- 1 diagnosed patient recruited in three clinical centers in Poland (two in Warsaw, one in Ostróda)

You may not qualify if:

• Lack of HIV genotyping before ART treatment or change of ART

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Department of Infectious Diseases, Tropical Diseases and Hepatology, Medical University of Warsaw

Warsaw, Mazowia, 01-201, Poland

Location

Related Publications (12)

• Rhee SY, Kassaye SG, Barrow G, Sundaramurthi JC, Jordan MR, Shafer RW. HIV-1 transmitted drug resistance surveillance: shifting trends in study design and prevalence estimates. J Int AIDS Soc. 2020 Sep;23(9):e25611. doi: 10.1002/jia2.25611.

  PMID: 32936523 BACKGROUND

• Wensing AM, Calvez V, Ceccherini-Silberstein F, Charpentier C, Gunthard HF, Paredes R, Shafer RW, Richman DD. 2022 update of the drug resistance mutations in HIV-1. Top Antivir Med. 2022 Oct;30(4):559-574.

  PMID: 36375130 BACKGROUND

• Mazzuti L, Melengu T, Falasca F, Calabretto M, Cella E, Ciccozzi M, Mezzaroma I, Iaiani G, Spaziante M, d'Ettorre G, Fimiani C, Vullo V, Antonelli G, Turriziani O. Transmitted drug resistance mutations and trends of HIV-1 subtypes in treatment-naive patients: A single-centre experience. J Glob Antimicrob Resist. 2020 Mar;20:298-303. doi: 10.1016/j.jgar.2019.08.024. Epub 2019 Sep 10.

  PMID: 31518723 BACKGROUND

• Swindells S, Lutz T, Van Zyl L, Porteiro N, Stoll M, Mitha E, Shon A, Benn P, Huang JO, Harrington CM, Hove K, Ford SL, Talarico CL, Chounta V, Crauwels H, Van Solingen-Ristea R, Vanveggel S, Margolis DA, Smith KY, Vandermeulen K, Spreen WR. Week 96 extension results of a Phase 3 study evaluating long-acting cabotegravir with rilpivirine for HIV-1 treatment. AIDS. 2022 Feb 1;36(2):185-194. doi: 10.1097/QAD.0000000000003025.

  PMID: 34261093 BACKGROUND

• Landovitz RJ, Donnell D, Clement ME, Hanscom B, Cottle L, Coelho L, Cabello R, Chariyalertsak S, Dunne EF, Frank I, Gallardo-Cartagena JA, Gaur AH, Gonzales P, Tran HV, Hinojosa JC, Kallas EG, Kelley CF, Losso MH, Madruga JV, Middelkoop K, Phanuphak N, Santos B, Sued O, Valencia Huamani J, Overton ET, Swaminathan S, Del Rio C, Gulick RM, Richardson P, Sullivan P, Piwowar-Manning E, Marzinke M, Hendrix C, Li M, Wang Z, Marrazzo J, Daar E, Asmelash A, Brown TT, Anderson P, Eshleman SH, Bryan M, Blanchette C, Lucas J, Psaros C, Safren S, Sugarman J, Scott H, Eron JJ, Fields SD, Sista ND, Gomez-Feliciano K, Jennings A, Kofron RM, Holtz TH, Shin K, Rooney JF, Smith KY, Spreen W, Margolis D, Rinehart A, Adeyeye A, Cohen MS, McCauley M, Grinsztejn B; HPTN 083 Study Team. Cabotegravir for HIV Prevention in Cisgender Men and Transgender Women. N Engl J Med. 2021 Aug 12;385(7):595-608. doi: 10.1056/NEJMoa2101016.

  PMID: 34379922 BACKGROUND

• Bokharaei-Salim F, Esghaei M, Khanaliha K, Kalantari S, Marjani A, Fakhim A, Keyvani H. HIV-1 reverse transcriptase and protease mutations for drug-resistance detection among treatment-experienced and naive HIV-infected individuals. PLoS One. 2020 Mar 2;15(3):e0229275. doi: 10.1371/journal.pone.0229275. eCollection 2020.

  PMID: 32119691 BACKGROUND

• Richardson D, Fitzpatrick C, Parkes L, Roberts J, Mulka L. HIV-1 transmitted drug resistance in Brighton, UK, from 2014 to 2020. Int J STD AIDS. 2021 Feb;32(2):199-201. doi: 10.1177/0956462420953043. Epub 2020 Dec 16.

  PMID: 33327896 BACKGROUND

• Branda F, Giovanetti M, Sernicola L, Farcomeni S, Ciccozzi M, Borsetti A. Comprehensive Analysis of HIV-1 Integrase Resistance-Related Mutations in African Countries. Pathogens. 2024 Jan 24;13(2):102. doi: 10.3390/pathogens13020102.

  PMID: 38392840 BACKGROUND

• Scherrer AU, von Wyl V, Yang WL, Kouyos RD, Boni J, Yerly S, Klimkait T, Aubert V, Cavassini M, Battegay M, Furrer H, Calmy A, Vernazza P, Bernasconi E, Gunthard HF; Swiss HIV Cohort Study; Aubert V, Battegay M, Bernasconi E, Boni J, Braun DL, Bucher HC, Burton-Jeangros C, Calmy A, Cavassini M, Dollenmaier G, Egger M, Elzi L, Fehr J, Fellay J, Furrer H, Fux CA, Gorgievski M, Gunthard H, Haerry D, Hasse B, Hirsch HH, Hoffmann M, Hosli I, Kahlert C, Kaiser L, Keiser O, Klimkait T, Kouyos R, Kovari H, Ledergerber B, Martinetti G, Martinez de Tejada B, Marzolini C, Metzner K, Muller N, Nadal D, Nicca D, Pantaleo G, Rauch A, Regenass S, Rudin C, Schoni-Affolter F, Schmid P, Speck R, Stockle M, Tarr P, Trkola A, Vernazza P, Weber R, Yerly S. Emergence of Acquired HIV-1 Drug Resistance Almost Stopped in Switzerland: A 15-Year Prospective Cohort Analysis. Clin Infect Dis. 2016 May 15;62(10):1310-1317. doi: 10.1093/cid/ciw128. Epub 2016 Mar 8.

  PMID: 26962075 BACKGROUND

• Rossetti B, Di Giambenedetto S, Torti C, Postorino MC, Punzi G, Saladini F, Gennari W, Borghi V, Monno L, Pignataro AR, Polilli E, Colafigli M, Poggi A, Tini S, Zazzi M, De Luca A; Antiviral Response Cohort Analysis (ARCA) Collaborative Group. Evolution of transmitted HIV-1 drug resistance and viral subtypes circulation in Italy from 2006 to 2016. HIV Med. 2018 Oct;19(9):619-628. doi: 10.1111/hiv.12640. Epub 2018 Jun 22.

  PMID: 29932313 BACKGROUND

• Pingarilho M, Pimentel V, Diogo I, Fernandes S, Miranda M, Pineda-Pena A, Libin P, Theys K, Martins MRO, Vandamme AM, Camacho R, Gomes P, Abecasis A. Increasing Prevalence of HIV-1 Transmitted Drug Resistance in Portugal: Implications for First Line Treatment Recommendations. Viruses. 2020 Oct 30;12(11):1238. doi: 10.3390/v12111238.

  PMID: 33143301 BACKGROUND

• Nijhuis M, Schuurman R, de Jong D, Erickson J, Gustchina E, Albert J, Schipper P, Gulnik S, Boucher CA. Increased fitness of drug resistant HIV-1 protease as a result of acquisition of compensatory mutations during suboptimal therapy. AIDS. 1999 Dec 3;13(17):2349-59. doi: 10.1097/00002030-199912030-00006.

  PMID: 10597776 BACKGROUND

Study Officials

• Andrzej Załęski, PhD

  Medical University of Warsaw

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrzej Załęski, PhD

CONTACT

600982185; andrzejzaleski84@wp.pl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: October 28, 2024
• Study Start: November 1, 2024
• Primary Completion: November 30, 2024
• Study Completion: December 30, 2024
• Last Updated: October 28, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)