HIV-DNA Dynamics in HIV Monoinfected or HIV/HCV Coinfected Patients (ViDyMoCo)
23. juli 2019 opdateret af: Simona Di Giambenedetto, Catholic University of the Sacred Heart
Dynamics of Viral Reservoir in HIV-positive Patients With or Without HCV Coinfection in the Era of Direct-acting Antiviral and Antiretroviral Drugs
New markers of viral activity are now under investigation.
Aim of the study is to investigate the efficacy of new antiretroviral drugs by monitoring HIV-DNA dynamics in HIV-positive population.
In HIV/HCV coinfected population, the study of HIV reservoir dynamics and the analysis of the prevalence of HCV resistance-associated mutations will help clinicians to improve the management of coinfected patients.
Studieoversigt
Detaljeret beskrivelse
New markers of viral activity are now under investigation. Besides HIV-RNA and CD4 cells count, HIV-DNA is an emerging marker of viral reservoir, that seems to be associated with the risk of HIV-related diseases, especially in HCV coinfected patients. New antiretroviral drugs, particularly integrase inhibitors, are expected to decrease residual viremia and, consequently, viral reservoir. Monitoring of HIV-DNA dynamics during antiretroviral treatment could lead to a better management of HIV infected population.
Also, the role of HCV in influencing HIV natural history requires careful monitoring. In particular, with a broader use of direct acting antiretroviral, the analysis of prevalence of HCV resistance associated mutation will be more and more important to manage patients with treatment failure.
Undersøgelsestype
Observationel
Tilmelding (Forventet)
600
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Simona Di Giambenedetto, Researcher
- Telefonnummer: 0630155366
- E-mail: simona.digiambenedetto@unicatt.it
Studiesteder
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Rome, Italien, 00168
- Rekruttering
- Catholic University Of Sacred Heart
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Kontakt:
- Simona Di Giambenedetto, Researcher
- Telefonnummer: 00390630155366
- E-mail: simona.digiambenedetto@unicatt.it
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
HIV-infected patients
Beskrivelse
Inclusion Criteria:
- Persons ≥ 18 years-old;
- Signing an informed consent to study participation and data treatment;
- HIV-positive patients, beginning a new antiretroviral treatment patients or with clinically relevant events;
- HCV-positive patients beginning an antiviral treatment with DAA.
Exclusion Criteria:
- Patient's deny
- Clinical contraindications to blood sample withdrawal
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Økologisk eller fællesskab
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
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Naive patients
Patients who begin their first antiretroviral regimen.
Blood sample withdrawal
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Blood withdrawal for HIV-DNA or HCV resistance test
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Experienced patients
Patients with a history of antiretroviral treatment, switching to a new regimen. Blood sample withdrawal |
Blood withdrawal for HIV-DNA or HCV resistance test
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Percentage of HIV-positive patients with a significant HIV-DNA decay after 3 years from a new antiretroviral regimen start
Tidsramme: up to 144 weeks
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up to 144 weeks
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Percentage of HIV/HCV coinfected patients with a significant HIV-DNA decay after 3 years from the enrollment
Tidsramme: up to 144 weeks
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up to 144 weeks
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Measurement of HIV-DNA level during HCV antiviral therapy with DAA in HIV/HCV coinfected patients
Tidsramme: up to 24 weeks
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up to 24 weeks
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Prevalence of HCV resistance-associated variants and their relation with HIV-DNA levels in HIV/HCV coinfected patients, treated or not treated for HCV.
Tidsramme: up to 144 weeks
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up to 144 weeks
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Comparison of the prevalence of HCV resistance-associated variants in HIV/HCV coinfected population versus HCV monoinfected population
Tidsramme: up to 144 weeks
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up to 144 weeks
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Simona Di Giambenedetto, Researcher, Catholic University Of Sacred Heart
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Kostrikis LG, Touloumi G, Karanicolas R, Pantazis N, Anastassopoulou C, Karafoulidou A, Goedert JJ, Hatzakis A; Multicenter Hemophilia Cohort Study Group. Quantitation of human immunodeficiency virus type 1 DNA forms with the second template switch in peripheral blood cells predicts disease progression independently of plasma RNA load. J Virol. 2002 Oct;76(20):10099-108. doi: 10.1128/jvi.76.20.10099-10108.2002.
- Shiramizu B, Paul R, Williams A, Shikuma C, Watters M, Grove J, Valcour V. HIV proviral DNA associated with decreased neuropsychological function. J Neuropsychiatry Clin Neurosci. 2007 Spring;19(2):157-63. doi: 10.1176/jnp.2007.19.2.157.
- Asselah T, Boyer N, Saadoun D, Martinot-Peignoux M, Marcellin P. Direct-acting antivirals for the treatment of hepatitis C virus infection: optimizing current IFN-free treatment and future perspectives. Liver Int. 2016 Jan;36 Suppl 1:47-57. doi: 10.1111/liv.13027.
- Bagaglio S, Uberti-Foppa C, Messina E, Merli M, Hasson H, Andolina A, Galli A, Lazzarin A, Morsica G. Distribution of natural resistance to NS3 protease inhibitors in hepatitis C genotype 1a separated into clades 1 and 2 and in genotype 1b of HIV-infected patients. Clin Microbiol Infect. 2016 Apr;22(4):386.e1-386.e3. doi: 10.1016/j.cmi.2015.12.007. Epub 2015 Dec 17.
- Di Maio VC, Cento V, Di Paolo D, Aragri M, De Leonardis F, Tontodonati M, Micheli V, Bellocchi MC, Antonucci FP, Bertoli A, Lenci I, Milana M, Gianserra L, Melis M, Di Biagio A, Sarrecchia C, Sarmati L, Landonio S, Francioso S, Lambiase L, Nicolini LA, Marenco S, Nosotti L, Giannelli V, Siciliano M, Romagnoli D, Pellicelli A, Vecchiet J, Magni CF, Babudieri S, Mura MS, Taliani G, Mastroianni C, Vespasiani-Gentilucci U, Romano M, Morisco F, Gasbarrini A, Vullo V, Bruno S, Baiguera C, Pasquazzi C, Tisone G, Picciotto A, Andreoni M, Parruti G, Rizzardini G, Angelico M, Perno CF, Ceccherini-Silberstein F; HCV Italian Resistance Network Study Group. HCV NS3 sequencing as a reliable and clinically useful tool for the assessment of genotype and resistance mutations for clinical samples with different HCV-RNA levels. J Antimicrob Chemother. 2016 Mar;71(3):739-50. doi: 10.1093/jac/dkv403. Epub 2015 Dec 17.
- AASLD/IDSA/IAS-USA RETREATMENT OF PERSONS IN WHOM PRIOR THERAPY HAS FAILED. Recommendations for testing, managing, and treating hepatitis C. date accessed 5.01. 2015.
- Fourati S, Pawlotsky JM. Virologic Tools for HCV Drug Resistance Testing. Viruses. 2015 Dec 4;7(12):6346-59. doi: 10.3390/v7122941.
- Perales C, Quer J, Gregori J, Esteban JI, Domingo E. Resistance of Hepatitis C Virus to Inhibitors: Complexity and Clinical Implications. Viruses. 2015 Nov 6;7(11):5746-66. doi: 10.3390/v7112902.
- Lombardi F, Belmonti S, Borghetti A, Fabbiani M, Marchetti S, Tamburrini E, Cauda R, di Giambenedetto S. Evolution of cellular HIV DNA levels in virologically suppressed patients switching to dolutegravir/lamivudine versus maintaining a triple regimen: a prospective, longitudinal, matched, controlled study. J Antimicrob Chemother. 2020 Jun 1;75(6):1599-1603. doi: 10.1093/jac/dkaa058.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. april 2016
Primær færdiggørelse (Forventet)
1. april 2020
Studieafslutning (Forventet)
1. april 2025
Datoer for studieregistrering
Først indsendt
5. maj 2016
Først indsendt, der opfyldte QC-kriterier
14. juli 2016
Først opslået (Skøn)
19. juli 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
24. juli 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. juli 2019
Sidst verificeret
1. juli 2019
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- Prot.7768/16 ID 1086
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Uafklaret
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