HIV-1-infectionV106IFCNCT04894357
Impact of V106I on Resistance to Doravirine
An observational study of HIV-1-infection, run by Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental.
Trial summary
Objective. To study the impact of V106I mutation in the reverse transcriptase of HIV-1 on the activity of Doravirine. Clinical hypotheses. Doravirine shows a unique resistance pattern with a higher genetic barrier to resistance than other NNRTIs. Read more about this study
- Who is it for?
- Ages 13 to 75 years
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- Phenotypic resistance measure
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2021to 1 May 2022
- 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 13 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: HIV positive patients, newly diagnosed and naive to antiretroviral treatment
Who may be able to join
- Antiretroviral-naïve subjects over 13 years of age, including both seroprevalent and seroconverter patients
Who cannot join
- Patients with prior antiretroviral exposure
- -
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Phenotypic and Site Directed Mutagenesis Analysis on the Impact of V106I in HIV-1 Reverse Transcriptase on Resistance to Doravirine
Objective. To study the impact of V106I mutation in the reverse transcriptase of HIV-1 on the activity of Doravirine.
Clinical hypotheses.
Doravirine shows a unique resistance pattern with a higher genetic barrier to resistance than other NNRTIs. In contrast to K103N or E138A, the prevalence of single mutations and/or combination of mutations against Doravirine is low. However, in a recent survey conducted in Spain the study investigators have found a V106Iprevalence similar to K103N and E138A. There is a clear need to understand the real impact of this mutation on Doravirine resistance.
Read the detailed description
Testing for transmitted drug resistance (TDR) in the reverse transcriptase and protease in newly diagnosed patients with HIV is recommended by treatment guidelines. Currently clinical practice for first line treatment is moving to a test and treat approach. In this setting, Spanish GESIDA guidelines indicate that a first line protease (PI) or integrase (INI) inhibitor-based regimen may be started even if results from baseline resistance are yet not available. This indication is based on the very low prevalence of INI or PI TDR.
In Europe, TDR to NNRTIs has stabilized between 4-5%. Doravirine has a unique mutational pattern and its activity is affected by mutations that are usually not found at baseline as TDR (V106A/M, V108I, Y188L, G190S, F227 C/L/V, M230I/L, L234I, P236L Y318F and K103N/Y181C), as a recent European survey has already shown. In addition, these findings have been confirmed in a survey the study investigators have conducted in Spain. However, in this study the Stanford algorithm was used to evaluate clinical resistance to NNRTIs and, surprisingly found an unexpected high prevalence of resistance to Doravirine (as high as for first generation NNRTIs). Study investigators detected that resistance to Doravirine was mainly driven by V106I mutation, which Stanford scores as "low-level resistance".
MeditRes is a consortium of HIV clinical virologists from France (leader Anne-Genevieve Marcellin, Paris), Italy (leader Francesca Ceccerini-Silbesrtein, Rome, Spain (leader Federico García, Granada), Greece (leader Dimitrios Paraskevis, Athens) and Portugal (leader Perpetua Gomes, Lisbon). Each of these team leaders has access/coordinate local or national cohorts in their countries.
This study aims to investigate the prevalence of V106I TDR in patients joining the MEDITRES consortium during years 2018 and 2019. In patients carrying V106I in the background of a wild-type virus phenotypic resistance to Doravirine will be evaluated the Fold-Change (FC) will be calculated. In addition, Site Directed Mutagenesis (SDM) will be used to evaluate FC to Doravirine in the background of B and CRF02-AG subtypes. Patient recruitment will follow general recruitment procedures to be incorporated into each running cohorts currently contributing to MEDITRES (multicentre, prospective cohort of HIV-positive, antiretroviral-naïve subjects over 18 years of age, including both seroprevalent and seroconverter patients).
- Conditions
- HIV-1-infection
- Being tested
- Phenotypic resistance measure
- Keywords
- doravirine, resistance, V106I
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phenotypic resistance measureOther
SDM experiments: Reverse transcriptase mutants of HIV-1 will be obtained by site-directed mutagenesis using specific primers introducing the expected mutations into plasmids pNL4.3 and CRF02_AG. HIV-1 stocks will be obtained by transfecting 293-T cells with the various HIV-1 molecular clones. 48 hours after transfection, the viral supernatants will be recovered, quantified for HIV-1p24gag antigen (Vidas BioMérieux) and frozen at -80°C.The single-cycle virus titers will be determined on HeLa-P4 cells in which the expression of b-galactosidase is inducible by the HIV Tat protein. Phenotypic analysis: creation of replication competent chimeric viruses through homologous recombination between patient or laboratory virus-derived PCR fragments and the corresponding NL4-3 vector where the whole Gag-PR, RT-RNaseH or IN coding regions have been deleted through inverse PCR. The susceptibility to Doravirine will be calculated through a single round infection assay in TZM-bl cells.
What is being measured
The primary outcome is the main question the study is designed to answer.
Fold Change in resistance to Doravirine
Change in EC50 for resistance to Doravirine in the presence of V106I
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start1 Sep 2021 (estimated)
- Primary completion1 Oct 2021 (estimated)
- Study completion1 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Federico García, Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04894357
- Sponsor's protocol ID
- HUCSC-V106I
- Acronym
- V106IFC
- Status last verified
- Aug 2021
- First submitted
- 9 May 2021
- Last updated
- 18 Aug 2021
- Results posted
- No
Publications
Panel de expertos de GeSIDA y Plan Nacional sobre el Sida. [GESIDA/National AIDS Plan: Consensus document on antiretroviral therapy in adults infected by the human immunodeficiency virus (Updated January 2015)]. Enferm Infecc Microbiol Clin. 2015 Oct;33(8):543.e1-43. doi: 10.1016/j.eimc.2015.03.016. Epub 2015 May 7. Spanish.
PubMed 25959461Hofstra LM, Sauvageot N, Albert J, Alexiev I, Garcia F, Struck D, Van de Vijver DAMC, Asjo B, Beshkov D, Coughlan S, Descamps D, Griskevicius A, Hamouda O, Horban A, Van Kasteren M, Kolupajeva T, Kostrikis LG, Liitsola K, Linka M, Mor O, Nielsen C, Otelea D, Paraskevis D, Paredes R, Poljak M, Puchhammer-Stockl E, Sonnerborg A, Stanekova D, Stanojevic M, Van Laethem K, Zazzi M, Zidovec Lepej S, Boucher CAB, Schmit JC, Wensing AMJ; SPREAD Program; Puchhammer-Stockl E, Sarcletti M, Schmied B, Geit M, Balluch G, Vandamme AM, Vercauteren J, Derdelinckx I, Sasse A, Bogaert M, Ceunen H, De Roo A, De Wit S, Echahidi F, Fransen K, Goffard JC, Goubau P, Goudeseune E, Yombi JC, Lacor P, Liesnard C, Moutschen M, Pierard D, Rens R, Schrooten Y, Vaira D, Vandekerckhove LPR, Van den Heuvel A, Van Der Gucht B, Van Ranst M, Van Wijngaerden E, Vandercam B, Vekemans M, Verhofstede C, Clumeck N, Van Laethem K, Beshkov D, Alexiev I, Lepej SZ, Begovac J, Kostrikis L, Demetriades I, Kousiappa I, Demetriou V, Hezka J, Linka M, Maly M, Machala L, Nielsen C, Jorgensen LB, Gerstoft J, Mathiesen L, Pedersen C, Nielsen H, Laursen A, Kvinesdal B, Liitsola K, Ristola M, Suni J, Sutinen J, Descamps D, Assoumou L, Castor G, Grude M, Flandre P, Storto A, Hamouda O, Kucherer C, Berg T, Braun P, Poggensee G, Daumer M, Eberle J, Heiken H, Kaiser R, Knechten H, Korn K, Muller H, Neifer S, Schmidt B, Walter H, Gunsenheimer-Bartmeyer B, Harrer T, Paraskevis D, Hatzakis A, Zavitsanou A, Vassilakis A, Lazanas M, Chini M, Lioni A, Sakka V, Kourkounti S, Paparizos V, Antoniadou A, Papadopoulos A, Poulakou G, Katsarolis I, Protopapas K, Chryssos G, Drimis S, Gargalianos P, Xylomenos G, Lourida G, Psichogiou M, Daikos GL, Sipsas NV, Kontos A, Gamaletsou MN, Koratzanis G, Sambatakou H, Mariolis H, Skoutelis A, Papastamopoulos V, Georgiou O, Panagopoulos P, Maltezos E, Coughlan S, De Gascun C, Byrne C, Duffy M, Bergin C, Reidy D, Farrell G, Lambert J, O'Connor E, Rochford A, Low J, Coakely P, O'Dea S, Hall W, Mor O, Levi I, Chemtob D, Grossman Z, Zazzi M, de Luca A, Balotta C, Riva C, Mussini C, Caramma I, Capetti A, Colombo MC, Rossi C, Prati F, Tramuto F, Vitale F, Ciccozzi M, Angarano G, Rezza G, Kolupajeva T, Vasins O, Griskevicius A, Lipnickiene V, Schmit JC, Struck D, Sauvageot N, Hemmer R, Arendt V, Michaux C, Staub T, Sequin-Devaux C, Wensing AMJ, Boucher CAB, van de Vijver DAMC, van Kessel A, van Bentum PHM, Brinkman K, Connell BJ, van der Ende ME, Hoepelman IM, van Kasteren M, Kuipers M, Langebeek N, Richter C, Santegoets RMWJ, Schrijnders-Gudde L, Schuurman R, van de Ven BJM, Asjo B, Kran AB, Ormaasen V, Aavitsland P, Horban A, Stanczak JJ, Stanczak GP, Firlag-Burkacka E, Wiercinska-Drapalo A, Jablonowska E, Maolepsza E, Leszczyszyn-Pynka M, Szata W, Camacho R, Palma C, Borges F, Paixao T, Duque V, Araujo F, Otelea D, Paraschiv S, Tudor AM, Cernat R, Chiriac C, Dumitrescu F, Prisecariu LJ, Stanojevic M, Jevtovic D, Salemovic D, Stanekova D, Habekova M, Chabadova Z, Drobkova T, Bukovinova P, Shunnar A, Truska P, Poljak M, Lunar M, Babic D, Tomazic J, Vidmar L, Vovko T, Karner P, Garcia F, Paredes R, Monge S, Moreno S, Del Amo J, Asensi V, Sirvent JL, de Mendoza C, Delgado R, Gutierrez F, Berenguer J, Garcia-Bujalance S, Stella N, de Los Santos I, Blanco JR, Dalmau D, Rivero M, Segura F, Elias MJP, Alvarez M, Chueca N, Rodriguez-Martin C, Vidal C, Palomares JC, Viciana I, Viciana P, Cordoba J, Aguilera A, Domingo P, Galindo MJ, Miralles C, Del Pozo MA, Ribera E, Iribarren JA, Ruiz L, de la Torre J, Vidal F, Clotet B, Albert J, Heidarian A, Aperia-Peipke K, Axelsson M, Mild M, Karlsson A, Sonnerborg A, Thalme A, Naver L, Bratt G, Karlsson A, Blaxhult A, Gisslen M, Svennerholm B, Bergbrant I, Bjorkman P, Sall C, Mellgren A, Lindholm A, Kuylenstierna N, Montelius R, Azimi F, Johansson B, Carlsson M, Johansson E, Ljungberg B, Ekvall H, Strand A, Makitalo S, Oberg S, Holmblad P, Hofer M, Holmberg H, Josefson P, Ryding U. Transmission of HIV Drug Resistance and the Predicted Effect on Current First-line Regimens in Europe. Clin Infect Dis. 2016 Mar 1;62(5):655-663. doi: 10.1093/cid/civ963. Epub 2015 Nov 29.
PubMed 26620652Soulie C, Santoro MM, Charpentier C, Storto A, Paraskevis D, Di Carlo D, Gennari W, Sterrantino G, Zazzi M, Perno CF, Calvez V, Descamps D, Ceccherini-Silberstein F, Marcelin AG. Rare occurrence of doravirine resistance-associated mutations in HIV-1-infected treatment-naive patients. J Antimicrob Chemother. 2019 Mar 1;74(3):614-617. doi: 10.1093/jac/dky464.
PubMed 30476106Guerrero-Beltran C, Martinez-Sanz J, Alvarez M, Olalla J, Garcia-Alvarez M, Iribarren JA, Masia M, Montero M, Garcia-Bujalance S, Blanco JR, Rivero M, Garcia-Fraile LJ, Espinosa N, Rodriguez C, Aguilera A, Vidal-Ampurdanes MC, Martinez M, Iborra A, Imaz A, Gomez-Sirvent JL, Peraire J, Portilla J, Caballero E, Alejos B, Garcia F, Moreno S; CoRIS. The algorithm used for the interpretation of doravirine transmitted drug resistance strongly influences clinical practice and guideline recommendations. J Antimicrob Chemother. 2020 May 1;75(5):1294-1300. doi: 10.1093/jac/dkaa009.
PubMed 32030406Giammarino F, de Salazar A, Malet I, Vinuela L, Fuentes A, Saladini F, Bartolini N, Charpentier C, Lambert-Niclot S, Sterrantino G, Colao MG, Micheli V, Bertoli A, Fabeni L, Teyssou E, Delgado R, Falces-Romero I, Aguilera A, Gomes P, Paraskevis D, Santoro MM, Ceccherini-Silberstein F, Marcelin AG, Moreno C, Zazzi M, Garcia F. Prevalence and Phenotypic Susceptibility to Doravirine of the HIV-1 Reverse Transcriptase V106I Polymorphism in B and Non-B Subtypes. J Infect Dis. 2024 Jun 14;229(6):1796-1802. doi: 10.1093/infdis/jiae010.
PubMed 38206187
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenotypic and Site Directed Mutagenesis Analysis on the Impact of V106I in HIV-1 Reverse Transcriptase on Resistance to Doravirine
- ClinicalTrials.gov ID
- NCT04894357
- Acronym / sponsor ID
- V106IFC / HUCSC-V106I
- Conditions
- HIV-1-infection
- Keywords
- doravirine, resistance, V106I
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fundación Pública Andaluza para la Investigación Biomédica Andalucía OrientalUniversity, hospital or other
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 20 May 2021 (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.
Objective. To study the impact of V106I mutation in the reverse transcriptase of HIV-1 on the activity of Doravirine.
Clinical hypotheses.
Doravirine shows a unique resistance pattern with a higher genetic barrier to resistance than other NNRTIs. In contrast to K103N or E138A, the prevalence of single mutations and/or combination of mutations against Doravirine is low. However, in a recent survey conducted in Spain the study investigators have found a V106Iprevalence similar to K103N and E138A. There is a clear need to understand the real impact of this mutation on Doravirine resistance.
Detailed description
Testing for transmitted drug resistance (TDR) in the reverse transcriptase and protease in newly diagnosed patients with HIV is recommended by treatment guidelines. Currently clinical practice for first line treatment is moving to a test and treat approach. In this setting, Spanish GESIDA guidelines indicate that a first line protease (PI) or integrase (INI) inhibitor-based regimen may be started even if results from baseline resistance are yet not available. This indication is based on the very low prevalence of INI or PI TDR.
In Europe, TDR to NNRTIs has stabilized between 4-5%. Doravirine has a unique mutational pattern and its activity is affected by mutations that are usually not found at baseline as TDR (V106A/M, V108I, Y188L, G190S, F227 C/L/V, M230I/L, L234I, P236L Y318F and K103N/Y181C), as a recent European survey has already shown. In addition, these findings have been confirmed in a survey the study investigators have conducted in Spain. However, in this study the Stanford algorithm was used to evaluate clinical resistance to NNRTIs and, surprisingly found an unexpected high prevalence of resistance to Doravirine (as high as for first generation NNRTIs). Study investigators detected that resistance to Doravirine was mainly driven by V106I mutation, which Stanford scores as "low-level resistance".
MeditRes is a consortium of HIV clinical virologists from France (leader Anne-Genevieve Marcellin, Paris), Italy (leader Francesca Ceccerini-Silbesrtein, Rome, Spain (leader Federico García, Granada), Greece (leader Dimitrios Paraskevis, Athens) and Portugal (leader Perpetua Gomes, Lisbon). Each of these team leaders has access/coordinate local or national cohorts in their countries.
This study aims to investigate the prevalence of V106I TDR in patients joining the MEDITRES consortium during years 2018 and 2019. In patients carrying V106I in the background of a wild-type virus phenotypic resistance to Doravirine will be evaluated the Fold-Change (FC) will be calculated. In addition, Site Directed Mutagenesis (SDM) will be used to evaluate FC to Doravirine in the background of B and CRF02-AG subtypes. Patient recruitment will follow general recruitment procedures to be incorporated into each running cohorts currently contributing to MEDITRES (multicentre, prospective cohort of HIV-positive, antiretroviral-naïve subjects over 18 years of age, including both seroprevalent and seroconverter patients).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 13 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- HIV positive patients, newly diagnosed and naive to antiretroviral treatment
Key inclusion criteria (1 listed)
- Antiretroviral-naïve subjects over 13 years of age, including both seroprevalent and seroconverter patients
Key exclusion criteria (2 listed)
- Patients with prior antiretroviral exposure
- -
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 |
|---|---|---|
| Phenotypic resistance measureSDM experiments: Reverse transcriptase mutants of HIV-1 will be obtained by site-directed mutagenesis using specific primers introducing the expected mutations into plasmids pNL4.3 and CRF02_AG. HIV-1 stocks will be obtained by transfecting 293-T cells with the various HIV-1 molecular clones. 48 hours after transfection, the viral supernatants will be recovered, quantified for HIV-1p24gag antigen (Vidas BioMérieux) and frozen at -80°C.The single-cycle virus titers will be determined on HeLa-P4 cells in which the expression of b-galactosidase is inducible by the HIV Tat protein. Phenotypic analysis: creation of replication competent chimeric viruses through homologous recombination between patient or laboratory virus-derived PCR fragments and the corresponding NL4-3 vector where the whole Gag-PR, RT-RNaseH or IN coding regions have been deleted through inverse PCR. The susceptibility to Doravirine will be calculated through a single round infection assay in TZM-bl cells. | Other | – |
Primary outcome
Fold Change in resistance to Doravirine
Time frame: Day 0
Change in EC50 for resistance to Doravirine in the presence of V106I
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2021.
- Background: PubMed 25959461Panel de expertos de GeSIDA y Plan Nacional sobre el Sida. [GESIDA/National AIDS Plan: Consensus document on antiretroviral therapy in adults infected by the human immunodeficiency virus (Updated January 2015)]. Enferm Infecc Microbiol Clin. 2015 Oct;33(8):543.e1-43. doi: 10.1016/j.eimc.2015.03.016. Epub 2015 May 7. Spanish.
- Background: PubMed 26620652Hofstra LM, Sauvageot N, Albert J, Alexiev I, Garcia F, Struck D, Van de Vijver DAMC, Asjo B, Beshkov D, Coughlan S, Descamps D, Griskevicius A, Hamouda O, Horban A, Van Kasteren M, Kolupajeva T, Kostrikis LG, Liitsola K, Linka M, Mor O, Nielsen C, Otelea D, Paraskevis D, Paredes R, Poljak M, Puchhammer-Stockl E, Sonnerborg A, Stanekova D, Stanojevic M, Van Laethem K, Zazzi M, Zidovec Lepej S, Boucher CAB, Schmit JC, Wensing AMJ; SPREAD Program; Puchhammer-Stockl E, Sarcletti M, Schmied B, Geit M, Balluch G, Vandamme AM, Vercauteren J, Derdelinckx I, Sasse A, Bogaert M, Ceunen H, De Roo A, De Wit S, Echahidi F, Fransen K, Goffard JC, Goubau P, Goudeseune E, Yombi JC, Lacor P, Liesnard C, Moutschen M, Pierard D, Rens R, Schrooten Y, Vaira D, Vandekerckhove LPR, Van den Heuvel A, Van Der Gucht B, Van Ranst M, Van Wijngaerden E, Vandercam B, Vekemans M, Verhofstede C, Clumeck N, Van Laethem K, Beshkov D, Alexiev I, Lepej SZ, Begovac J, Kostrikis L, Demetriades I, Kousiappa I, Demetriou V, Hezka J, Linka M, Maly M, Machala L, Nielsen C, Jorgensen LB, Gerstoft J, Mathiesen L, Pedersen C, Nielsen H, Laursen A, Kvinesdal B, Liitsola K, Ristola M, Suni J, Sutinen J, Descamps D, Assoumou L, Castor G, Grude M, Flandre P, Storto A, Hamouda O, Kucherer C, Berg T, Braun P, Poggensee G, Daumer M, Eberle J, Heiken H, Kaiser R, Knechten H, Korn K, Muller H, Neifer S, Schmidt B, Walter H, Gunsenheimer-Bartmeyer B, Harrer T, Paraskevis D, Hatzakis A, Zavitsanou A, Vassilakis A, Lazanas M, Chini M, Lioni A, Sakka V, Kourkounti S, Paparizos V, Antoniadou A, Papadopoulos A, Poulakou G, Katsarolis I, Protopapas K, Chryssos G, Drimis S, Gargalianos P, Xylomenos G, Lourida G, Psichogiou M, Daikos GL, Sipsas NV, Kontos A, Gamaletsou MN, Koratzanis G, Sambatakou H, Mariolis H, Skoutelis A, Papastamopoulos V, Georgiou O, Panagopoulos P, Maltezos E, Coughlan S, De Gascun C, Byrne C, Duffy M, Bergin C, Reidy D, Farrell G, Lambert J, O'Connor E, Rochford A, Low J, Coakely P, O'Dea S, Hall W, Mor O, Levi I, Chemtob D, Grossman Z, Zazzi M, de Luca A, Balotta C, Riva C, Mussini C, Caramma I, Capetti A, Colombo MC, Rossi C, Prati F, Tramuto F, Vitale F, Ciccozzi M, Angarano G, Rezza G, Kolupajeva T, Vasins O, Griskevicius A, Lipnickiene V, Schmit JC, Struck D, Sauvageot N, Hemmer R, Arendt V, Michaux C, Staub T, Sequin-Devaux C, Wensing AMJ, Boucher CAB, van de Vijver DAMC, van Kessel A, van Bentum PHM, Brinkman K, Connell BJ, van der Ende ME, Hoepelman IM, van Kasteren M, Kuipers M, Langebeek N, Richter C, Santegoets RMWJ, Schrijnders-Gudde L, Schuurman R, van de Ven BJM, Asjo B, Kran AB, Ormaasen V, Aavitsland P, Horban A, Stanczak JJ, Stanczak GP, Firlag-Burkacka E, Wiercinska-Drapalo A, Jablonowska E, Maolepsza E, Leszczyszyn-Pynka M, Szata W, Camacho R, Palma C, Borges F, Paixao T, Duque V, Araujo F, Otelea D, Paraschiv S, Tudor AM, Cernat R, Chiriac C, Dumitrescu F, Prisecariu LJ, Stanojevic M, Jevtovic D, Salemovic D, Stanekova D, Habekova M, Chabadova Z, Drobkova T, Bukovinova P, Shunnar A, Truska P, Poljak M, Lunar M, Babic D, Tomazic J, Vidmar L, Vovko T, Karner P, Garcia F, Paredes R, Monge S, Moreno S, Del Amo J, Asensi V, Sirvent JL, de Mendoza C, Delgado R, Gutierrez F, Berenguer J, Garcia-Bujalance S, Stella N, de Los Santos I, Blanco JR, Dalmau D, Rivero M, Segura F, Elias MJP, Alvarez M, Chueca N, Rodriguez-Martin C, Vidal C, Palomares JC, Viciana I, Viciana P, Cordoba J, Aguilera A, Domingo P, Galindo MJ, Miralles C, Del Pozo MA, Ribera E, Iribarren JA, Ruiz L, de la Torre J, Vidal F, Clotet B, Albert J, Heidarian A, Aperia-Peipke K, Axelsson M, Mild M, Karlsson A, Sonnerborg A, Thalme A, Naver L, Bratt G, Karlsson A, Blaxhult A, Gisslen M, Svennerholm B, Bergbrant I, Bjorkman P, Sall C, Mellgren A, Lindholm A, Kuylenstierna N, Montelius R, Azimi F, Johansson B, Carlsson M, Johansson E, Ljungberg B, Ekvall H, Strand A, Makitalo S, Oberg S, Holmblad P, Hofer M, Holmberg H, Josefson P, Ryding U. Transmission of HIV Drug Resistance and the Predicted Effect on Current First-line Regimens in Europe. Clin Infect Dis. 2016 Mar 1;62(5):655-663. doi: 10.1093/cid/civ963. Epub 2015 Nov 29.
- Background: PubMed 30476106Soulie C, Santoro MM, Charpentier C, Storto A, Paraskevis D, Di Carlo D, Gennari W, Sterrantino G, Zazzi M, Perno CF, Calvez V, Descamps D, Ceccherini-Silberstein F, Marcelin AG. Rare occurrence of doravirine resistance-associated mutations in HIV-1-infected treatment-naive patients. J Antimicrob Chemother. 2019 Mar 1;74(3):614-617. doi: 10.1093/jac/dky464.
- Background: PubMed 32030406Guerrero-Beltran C, Martinez-Sanz J, Alvarez M, Olalla J, Garcia-Alvarez M, Iribarren JA, Masia M, Montero M, Garcia-Bujalance S, Blanco JR, Rivero M, Garcia-Fraile LJ, Espinosa N, Rodriguez C, Aguilera A, Vidal-Ampurdanes MC, Martinez M, Iborra A, Imaz A, Gomez-Sirvent JL, Peraire J, Portilla J, Caballero E, Alejos B, Garcia F, Moreno S; CoRIS. The algorithm used for the interpretation of doravirine transmitted drug resistance strongly influences clinical practice and guideline recommendations. J Antimicrob Chemother. 2020 May 1;75(5):1294-1300. doi: 10.1093/jac/dkaa009.
- Derived from this study: PubMed 38206187Giammarino F, de Salazar A, Malet I, Vinuela L, Fuentes A, Saladini F, Bartolini N, Charpentier C, Lambert-Niclot S, Sterrantino G, Colao MG, Micheli V, Bertoli A, Fabeni L, Teyssou E, Delgado R, Falces-Romero I, Aguilera A, Gomes P, Paraskevis D, Santoro MM, Ceccherini-Silberstein F, Marcelin AG, Moreno C, Zazzi M, Garcia F. Prevalence and Phenotypic Susceptibility to Doravirine of the HIV-1 Reverse Transcriptase V106I Polymorphism in B and Non-B Subtypes. J Infect Dis. 2024 Jun 14;229(6):1796-1802. doi: 10.1093/infdis/jiae010.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV-1-infection, run by Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental.
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 2 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 18 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Federico Garcia, PhD (+34649894291, fegarcia@ugr.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fold Change in resistance to Doravirine (time frame: Day 0). 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 NCT04894357, which also lists 5 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 18 Aug 2021.