HIV-1-infectionNCT06661317
Primary and Secondary Drug Resistance Mutations (DRMs) in HIV As a Risk Factor of Failure of ART, Including Two Drugs Based Regimens.
An observational study of HIV-1-infection and DRM, run by Medical University of Warsaw at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- HIV-1-infection, DRM, DRM Gene Mutation
- How many people
- 200 participants
- Where
- 1 sitePoland
- Study dates
- 1 Nov 2024to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HIV- 1 diagnosed patient recruited in three clinical centers in Poland (two in Warsaw, one in Ostróda)
Who may be able to join
- Inclusion criteria were: diagnosis with HIV-1 infection, age 18 years or older.
Who cannot join
- Lack of HIV genotyping before ART treatment or change of ART
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Infectious Diseases, Tropical Diseases and Hepatology, Medical University of Warsaw
Warsaw, Mazowia, 01-201
Andrzej Załęski, PhD, 600982185, andrzejzaleski84@wp.pl
About this study
Official title: Presence of HIV-1 DRMs As a Risk Factor of Failure of Two Drugs Based ART Regimens, Including LAI ART, in Cohorts of Primary and Secondary DRMs.
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).
Read the detailed description
Introduction 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. Primary HIV DRMs occur in PLWH who have not previously been treated with ART. These people start treatment with a lower genetic barrier, a higher risk of virological failure and a higher risk of developing resistance to other drugs, which may lead to progression to AIDS. 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). The prevalence of major HIV-1 DRMs reported worldwide ranges from 5 to 25%, while in case of accessory (polymorphic) DRMs even up to 50%. It has been reported that in high-income countries the prevalence of sequences with acquired DRMs is decreasing, but the fraction of transmitted resistance is clearly increasing compared to the fraction of acquired DRMs, reaching even 70% of all cases of DRMs.
Aim of the study The choice of ART is based on epidemiological data regarding the presence of drug resistance mutations in HIV, as well on the basis of the HIV genotyping test results assessed before the start or change of the treatment. The presence of DRMs before ART initiation may be a risk factor for insufficient virological suppression, as the population of HIV is still evolving (changing due to mistakes during replication process). As well, inadequate antiretroviral therapy may drive the viral population first through a lower fitness level and then to a higher fitness level. Due to the constant changes in the pattern of HIV drug resistance (emergence of new mutations) and the introduction of new drugs into the treatment, including two drugs based regimens as LAI ART, we decided to conduct a study which determine the type and frequency of DRMs (including NRTI and NNRTI - RPV, 3TC and InSTI - CAB, DTG), in the population of previously untreated patients, as well as among patients with ART virological failure. The results may help in assessing the risk of ART failure, including LAI, and in determining ART regimens.
Methodology We aim to conduct multi-center, observational, cross sectional study. The patients' data will be extracted from the 2 year period (2023 - 2024). The site of the recruitment will be three clinical centers in Poland (two in Warsaw, one in Ostróda). Inclusion criteria are: diagnosis with HIV-1 infection, age 18 years or older. We will collect epidemiological data such as: age, gender, BMI, route of transmission also clinical and laboratory findings: HIV viral load, lymphocyte CD4 count and CD4:CD8 ratio (at the time of diagnosis/ change of therapy), presence of AIDS-defining diseases, implemented ART regimen. In all patients, before starting ART, the presence of HIV-1 DRMs to nucleoside reverse transcriptase inhibitors (NRTI), non-nucleoside reverse transcriptase inhibitors (NNRTI) protease inhibitors (PI) and integrase inhibitors (InSTI) will be evaluated, as a part of routine care.
The drug resistance genotyping of HIV-1 protease (PR) and reverse transcriptase (RT) coding region will be performed based on a Sanger sequencing method with use of commercially available ViroSeq HIV-1 Genotyping System (Abbott Molecular, Des Plains, IL, USA). The analysis procedure will be performed according to the manufacturer's instructions. HIV-1 RNA will be extracted manually from 0,5 mL of collected plasma samples by precipitation and centrifugation steps, followed by reverse transcription with MuLV reverse transcriptase. DNA products corresponding to the 1.8 kb pol region fragment will be generated in PCR with AmpliTaq Gold DNA Polymerase, after pre-incubation with Uracil-N-Glycosylase (UNG) enzyme. Where HIV-1 integrase coding region will be sequenced the ViroSeq HIV-1 Integrase Genotyping System (Celera Diagnostics, Alameda, CA, USA) will be applied with one step RT-PCR amplification reaction. Obtained PCR products will be purified enzymatically by incubation with Exo-SAP mix (Exonuclease I + Shrimp Alkaline Phosphatase), diluted if necessary, fluorescently labelled in reaction with appropriate terminators and sequenced by ABI Prism 3130 Genetic Analyzer using Data Collection Software (Applied Biosystems). The resulting sequence chromatograms will be assembled and analyzed using ViroSeq Genotyping System Software (Abbott Molecular). Drug resistance-associated mutations in protease, integrase and reverse transcriptase will be identified. The valid, quality checked pol sequences will be submitted to the Stanford University HIV Drug Resistance Database (http://hivdb.stanford.edu) in order to comparison of potential differences in the interpretation of the significance of genetic variants detected. For HIV-1 subtype and circular recombinant forms (CRFs) determination of partial pol submitted sequences REGA HIV-1 Subtyping Tool Version 3.0 will be used.
Statistical evaluation of the collected data will be performed in subgroups of PLWH with the presence of primary and secondary HIV DRMs. The analysis will also be performed in the subgroups of patients with different subtype HIV-1 infection. The Shapiro-Wilk test will be performed for the verification of the normality of the distributions in the analyzed variables. Student's t-test or Mann-Whitney U test will be used to evaluate the difference in mean value in continuous variables and χ 2 or Fisher exact tests will be performed for categorical variables. A p value of <0.05 will be considered statistically significant. Statistical analyses will be performed using Python 3.7 software and Statistica 13.1 program (StatSoft Poland, Kraków, Poland).
The clinical trial has received a positive opinion from the Bioethics Committee at the Medical University of Warsaw (number of consent: AKBE/72/2023). All analyzed patients' data will be fully anonymized. The study follows the principles of the Declaration of Helsinki.
- Conditions
- HIV-1-infection, DRM, DRM Gene Mutation, ART
- Being tested
- no intervention
- Keywords
- HIV, drug resistance mutations, DRM, LAI, ART, integrase inhibitors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| primary DRMs | patients with the presence of primary DRMs Receives: Other: no intervention | |
| secondary DRMs | patients with the presence of secondary DRMs Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency of DRMs
frequency of DRMs in all included patients
Measured: 2 years
Secondary outcomes (1)
frequency of primary and secondary DRMs
frequency of primary and secondary DRMs, including resistance to InSTI
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start1 Nov 2024 (estimated)
- Primary completion30 Nov 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrzej Załęski, PhD, Principal investigator, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06661317
- Sponsor's protocol ID
- Primary and secondary HIV DRMs
- Status last verified
- Jun 2024
- First submitted
- 24 Oct 2024
- Last updated
- 28 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data extracted from medical records
Publications
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.
PubMed 32936523Wensing 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.
PubMed 36375130Mazzuti 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.
PubMed 31518723Swindells 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.
PubMed 34261093Landovitz 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.
PubMed 34379922Bokharaei-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.
PubMed 32119691Richardson 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.
PubMed 33327896Branda 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.
PubMed 38392840Scherrer 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.
PubMed 26962075Rossetti 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.
PubMed 29932313Pingarilho 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.
PubMed 33143301Nijhuis 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.
PubMed 10597776Zaleski A, Lembas A, Osinska J, Dyda T, Suchacz M, Stempkowska-Rejek J, Orzechowska J, Wiercinska-Drapalo A. The Epidemiology of HIV-1 Resistance to Two-Drug Regimens in Multicenter Cohort From Poland-A Cross-Sectional Study. Health Sci Rep. 2026 Mar 19;9(3):e71997. doi: 10.1002/hsr2.71997. eCollection 2026 Mar.
PubMed 42022637
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Presence of HIV-1 DRMs As a Risk Factor of Failure of Two Drugs Based ART Regimens, Including LAI ART, in Cohorts of Primary and Secondary DRMs.
- ClinicalTrials.gov ID
- NCT06661317
- Acronym / sponsor ID
- Primary and secondary HIV DRMs
- Conditions
- HIV-1-infection, DRM, DRM Gene Mutation, ART
- Keywords
- HIV, drug resistance mutations, DRM, LAI, ART, integrase inhibitors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 28 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Introduction 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. Primary HIV DRMs occur in PLWH who have not previously been treated with ART. These people start treatment with a lower genetic barrier, a higher risk of virological failure and a higher risk of developing resistance to other drugs, which may lead to progression to AIDS. 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). The prevalence of major HIV-1 DRMs reported worldwide ranges from 5 to 25%, while in case of accessory (polymorphic) DRMs even up to 50%. It has been reported that in high-income countries the prevalence of sequences with acquired DRMs is decreasing, but the fraction of transmitted resistance is clearly increasing compared to the fraction of acquired DRMs, reaching even 70% of all cases of DRMs.
Aim of the study The choice of ART is based on epidemiological data regarding the presence of drug resistance mutations in HIV, as well on the basis of the HIV genotyping test results assessed before the start or change of the treatment. The presence of DRMs before ART initiation may be a risk factor for insufficient virological suppression, as the population of HIV is still evolving (changing due to mistakes during replication process). As well, inadequate antiretroviral therapy may drive the viral population first through a lower fitness level and then to a higher fitness level. Due to the constant changes in the pattern of HIV drug resistance (emergence of new mutations) and the introduction of new drugs into the treatment, including two drugs based regimens as LAI ART, we decided to conduct a study which determine the type and frequency of DRMs (including NRTI and NNRTI - RPV, 3TC and InSTI - CAB, DTG), in the population of previously untreated patients, as well as among patients with ART virological failure. The results may help in assessing the risk of ART failure, including LAI, and in determining ART regimens.
Methodology We aim to conduct multi-center, observational, cross sectional study. The patients' data will be extracted from the 2 year period (2023 - 2024). The site of the recruitment will be three clinical centers in Poland (two in Warsaw, one in Ostróda). Inclusion criteria are: diagnosis with HIV-1 infection, age 18 years or older. We will collect epidemiological data such as: age, gender, BMI, route of transmission also clinical and laboratory findings: HIV viral load, lymphocyte CD4 count and CD4:CD8 ratio (at the time of diagnosis/ change of therapy), presence of AIDS-defining diseases, implemented ART regimen. In all patients, before starting ART, the presence of HIV-1 DRMs to nucleoside reverse transcriptase inhibitors (NRTI), non-nucleoside reverse transcriptase inhibitors (NNRTI) protease inhibitors (PI) and integrase inhibitors (InSTI) will be evaluated, as a part of routine care.
The drug resistance genotyping of HIV-1 protease (PR) and reverse transcriptase (RT) coding region will be performed based on a Sanger sequencing method with use of commercially available ViroSeq HIV-1 Genotyping System (Abbott Molecular, Des Plains, IL, USA). The analysis procedure will be performed according to the manufacturer's instructions. HIV-1 RNA will be extracted manually from 0,5 mL of collected plasma samples by precipitation and centrifugation steps, followed by reverse transcription with MuLV reverse transcriptase. DNA products corresponding to the 1.8 kb pol region fragment will be generated in PCR with AmpliTaq Gold DNA Polymerase, after pre-incubation with Uracil-N-Glycosylase (UNG) enzyme. Where HIV-1 integrase coding region will be sequenced the ViroSeq HIV-1 Integrase Genotyping System (Celera Diagnostics, Alameda, CA, USA) will be applied with one step RT-PCR amplification reaction. Obtained PCR products will be purified enzymatically by incubation with Exo-SAP mix (Exonuclease I + Shrimp Alkaline Phosphatase), diluted if necessary, fluorescently labelled in reaction with appropriate terminators and sequenced by ABI Prism 3130 Genetic Analyzer using Data Collection Software (Applied Biosystems). The resulting sequence chromatograms will be assembled and analyzed using ViroSeq Genotyping System Software (Abbott Molecular). Drug resistance-associated mutations in protease, integrase and reverse transcriptase will be identified. The valid, quality checked pol sequences will be submitted to the Stanford University HIV Drug Resistance Database (http://hivdb.stanford.edu) in order to comparison of potential differences in the interpretation of the significance of genetic variants detected. For HIV-1 subtype and circular recombinant forms (CRFs) determination of partial pol submitted sequences REGA HIV-1 Subtyping Tool Version 3.0 will be used.
Statistical evaluation of the collected data will be performed in subgroups of PLWH with the presence of primary and secondary HIV DRMs. The analysis will also be performed in the subgroups of patients with different subtype HIV-1 infection. The Shapiro-Wilk test will be performed for the verification of the normality of the distributions in the analyzed variables. Student's t-test or Mann-Whitney U test will be used to evaluate the difference in mean value in continuous variables and χ 2 or Fisher exact tests will be performed for categorical variables. A p value of <0.05 will be considered statistically significant. Statistical analyses will be performed using Python 3.7 software and Statistica 13.1 program (StatSoft Poland, Kraków, Poland).
The clinical trial has received a positive opinion from the Bioethics Committee at the Medical University of Warsaw (number of consent: AKBE/72/2023). All analyzed patients' data will be fully anonymized. The study follows the principles of the Declaration of Helsinki.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| primary DRMs | – | Other: no interventionpatients with the presence of primary DRMs |
| secondary DRMs | – | Other: no interventionpatients with the presence of secondary DRMs |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV- 1 diagnosed patient recruited in three clinical centers in Poland (two in Warsaw, one in Ostróda)
Key inclusion criteria (1 listed)
- Inclusion criteria were: diagnosis with HIV-1 infection, age 18 years or older.
Key exclusion criteria (1 listed)
- Lack of HIV genotyping before ART treatment or change of ART
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionno intervention | Other | primary DRMs, secondary DRMs |
Primary outcome
frequency of DRMs
Time frame: 2 years
frequency of DRMs in all included patients
1 secondary outcome
frequency of primary and secondary DRMs
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
- Background: PubMed 32936523Rhee 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.
- Background: PubMed 36375130Wensing 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.
- Background: PubMed 31518723Mazzuti 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.
- Background: PubMed 34261093Swindells 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.
- Background: PubMed 34379922Landovitz 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.
- Background: PubMed 32119691Bokharaei-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.
- Background: PubMed 33327896Richardson 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.
- Background: PubMed 38392840Branda 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.
- Background: PubMed 26962075Scherrer 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.
- Background: PubMed 29932313Rossetti 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.
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- Individual participant dataSharing planned: No. data extracted from medical records
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrzej Załęski, PhD principal investigator
Medical University of Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV-1-infection and DRM, run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrzej Załęski, PhD (600982185, andrzejzaleski84@wp.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
frequency of DRMs (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06661317, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2024.