Combating Related Epidemics in HCV (CREST)
30 april 2026 bijgewerkt door: Duke University
Combating Related Epidemics in HCV Through Simplified Testing and Treatment. A Cluster Randomized Trial of Point-of-care Hepatitis C Testing and Treatment Among Key Populations
This is a two-arm cluster randomized control trial to evaluate the effectiveness of a single-visit point-of-care (POC) test and treat bundle (intervention arm) compared to the current standard-of-care (SOC, control arm).
1:1 randomization occurs at the site level.
Studie Overzicht
Toestand
Nog niet aan het werven
Studietype
Ingrijpend
Inschrijving (Geschat)
1280
Fase
- Fase 4
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
Inclusion Criteria:
- Can provide written informed consent or assent
- Minimum of 16 years of age
- Willing to undergo HIV, HCV, HBV testing
- Willing to undergo treatment for HCV and complete study activities
Exclusion Criteria:
- History of HCV treatment for current infection
- Known preexisting (evidence or history of) decompensated liver disease based on: medical diagnosis through medical record, reporting by the participant, or clinical evidence per the site PI
- Contraindication for treatment with sofosbuvir/velpatasvir due to allergy or drug-drug interaction including use of any prohibited concomitant medications within 28 days prior to study entry.
- History of clinically significant illness or any other major medical disorder that may interfere with participant treatment, assessment, or compliance with study requirements as determined by the site PI
- Ongoing need for use of daily proton pump inhibitor (PPI) at doses ≥40 mg of omeprazole (or equivalent). NOTE: PPI can be discontinued or dose reduced to 20 mg/day of omeprazole (or equivalent) at time of study entry.
Retreatment Inclusion Criteria:
- Completion of sofosbuvir/velpatasvir treatment regimen as enrolled participant in CREST and willingness to receive retreatment. FIB-4 & CTP score available within 90-days of retreatment initiation.
- Meeting any of the below criteria during post-cessation treatment follow-up. Relapse, defined as HCV RNA <LLOQ/D (TD or TND) during and/or at end of treatment followed by HCV RNA >LLOQ/D or target detected based on qualitative POC test at any time point from end of treatment to 12 weeks after end of treatment OR Re-infection, defined as meeting the primary outcome criteria for SVR4+ followed by HCV RNA >LLOQ/D or target detected based on qualitative POC test at any time point beyond meeting SVR4+ OR Post-treatment virologic failure, defined as HCV RNA >LLOQ/D at any point after end of treatment (after week 24 visit) or during follow-up, not otherwise meeting definition of relapse or re-infection
Retreatment Exclusion Criteria:
- Known preexisting (evidence or history of) decompensated liver disease based on: medical diagnosis through medical record, reporting by the participant, clinical evidence per the site PI, or by CTP score ≥7.
- Pregnant or breast feeding at time of retreatment with sofosbuvir/velpatasvir/voxilaprevir.
- Contraindication for treatment with sofosbuvir/velpatasvir (reinfection) or sofosbuvir/velpatasvir/voxilaprevir (relapse or virologic failure) due to FDA package insert, allergy, or drug-drug interaction including use of any prohibited concomitant medications within 28 days prior to study entry.
- History of clinically significant illness or any other major medical disorder that may interfere with participant treatment, assessment, or compliance with study requirements as determined by the site PI
- Ongoing need for use of daily proton pump inhibitor (PPI) at doses ≥40 mg of omeprazole (or equivalent.). NOTE: PPI can be discontinued or dose reduced to 20 mg/day of omeprazole (or equivalent) at time of study entry.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Diagnostisch
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Actieve vergelijker: Standard of Care (control arm)
Participants will complete standard local clinical practice for HCV, HIV, and HBV testing and for initiation of treatment of HCV.
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Participants with detectable HCV RNA on Xpert test will receive sofosbuvir/velpatasvir at the same visit as the POC test in the intervention arm.
Participants in the SOC arm will receive sofosbuvir/velpatasvir after standard of care testing and treatment assessment has been completed.
Andere namen:
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Experimenteel: Single-visit POC test & treat (intervention arm)
Sites randomized to the single-visit point-of-care test (POC) & treat arm will undergo fingerstick POC HCV RNA, HIV antibody/antigen, and HBsAg and for those with detectable HCV RNA, HCV treatment will be initiated.
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Participants with detectable HCV RNA on Xpert test will receive sofosbuvir/velpatasvir at the same visit as the POC test in the intervention arm.
Participants in the SOC arm will receive sofosbuvir/velpatasvir after standard of care testing and treatment assessment has been completed.
Andere namen:
Cepheid Xpert HCV Test, performed on the GeneXpert Xpress system, in an automated in vitro reverse transcription polymerase chain reaction (RT-PCR) test for the qualitative detection of Hep C (HCV) RNA in human fingerstick.
Abbott Determine HIV - 1/2 Ag/Ab combo is an in vitro, visually read, qualitative immunoassay for the simultaneous detection of Human Immunodeficiency Virus type-1 (HIV-1) p24 antigen (Ag) and antibodies (Ab) to HIV type-1 and type-2 in fingerstick.
Intended use is point-of-care test to aid in the diagnosis of infection.
Determine HBsAg 2 is an in vitro, visually read, qualitative immunoassay for detection of Hepatitis B Surface Antigen (HBsAg) in human fingerstick.
The test is intended as an aid to detect HBAg from infected individuals.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Proportion of participants who complete the Hepatitis C Virus (HCV) care cascade within 24 weeks of study entry in intervention versus Standard of Care (SOC) arm.
Tijdsspanne: 24 weeks from study enrollment
|
Proportion of participants in the primary analysis population (as defined as detectable HCV RNA on dried blood spot testing at screening) who complete the HCV care cascade within 24 weeks of study entry in intervention versus SOC arm.
Completion of the care cascade will be defined as HCV RNA<lower limit of quantification/detection (LLOQ/D) at a minimum of 4 weeks post-cessation of direct-acting antiviral (DAA) therapy sustained virologic response (SVR4+).
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24 weeks from study enrollment
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Time from enrollment to treatment initiation
Tijdsspanne: up to 24 weeks
|
HCV related [all outcomes are assessed in the primary analysis population (as defined by dried blood spot testing at screening) and compared between intervention and SOC arms].
|
up to 24 weeks
|
|
Proportion of participants with HCV RNA not detected based on dried blood spot at week 24 and week 60
Tijdsspanne: Week 24 and 60
|
HCV related [all outcomes are assessed in the primary analysis population (as defined by dried blood spot testing at screening) and compared between intervention and SOC arms].
|
Week 24 and 60
|
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Proportion of participants who have received any HIV test result within 24 weeks of entry
Tijdsspanne: 24 weeks of entry
|
HIV related outcomes are assessed in the primary analysis population (as defined by entry dried blood spot testing at screening) and compared between intervention and SOC arms.
|
24 weeks of entry
|
|
Proportion of participants who initiate PrEP within 24 weeks of entry
Tijdsspanne: 24 weeks of entry
|
HIV related outcomes are assessed in the primary analysis population (as defined by entry dried blood spot testing at screening) and compared between intervention and SOC arms.
|
24 weeks of entry
|
|
Time from enrollment to PrEP initiation
Tijdsspanne: up to 60 weeks
|
HIV related [all outcomes are assessed in the primary analysis population (as defined by dried blood spot testing at screening) and compared between intervention and SOC arms].
|
up to 60 weeks
|
|
All cause and liver specific hospitalizations through week 60
Tijdsspanne: 60 weeks
|
Safety [all outcomes are assessed in the primary analysis population (as defined by dried blood spot testing at screening) and compared between intervention and SOC arms].
|
60 weeks
|
|
All cause and liver specific mortality through week 60
Tijdsspanne: Week 60
|
Safety [all outcomes are assessed in the primary analysis population (as defined by dried blood spot testing at screening) and compared between intervention and SOC arms].
|
Week 60
|
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Adverse device effects related to study devices
Tijdsspanne: up to 60 weeks
|
Safety [all outcomes are assessed in the primary analysis population (as defined by dried blood spot testing at screening) and compared between intervention and SOC arms].
|
up to 60 weeks
|
|
Proportion of participants initiating same-visit direct-acting antiviral (DAA) treatment following enrollment (intervention arm only)
Tijdsspanne: Day 1
|
Proportion of participants initiating same-visit DAA treatment following enrollment (intervention arm only)
|
Day 1
|
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Proportion of participants initiating direct-acting antiviral (DAA) therapy within 12 weeks of entry
Tijdsspanne: 12 weeks
|
HCV related outcomes are assessed in the primary analysis population (as defined by entry dried blood spot testing at screening) and compared between intervention and SOC arms.
|
12 weeks
|
|
Proportion of participants initiating direct-acting antiviral (DAA) therapy within 24 weeks of entry
Tijdsspanne: 24
|
HCV related [all outcomes are assessed in the primary analysis population (as defined by dried blood spot testing at screening) and compared between intervention and SOC arms].
|
24
|
|
Proportion of participants completing direct-acting antiviral (DAA) therapy within 24 weeks of entry
Tijdsspanne: 24 weeks
|
HCV related outcomes are assessed in the primary analysis population (as defined by entry dried blood spot testing at screening) and compared between intervention and SOC arms.
|
24 weeks
|
|
Proportion of participants achieving sustained virologic response (SVR4+) within 60 weeks of entry
Tijdsspanne: 60 weeks
|
HCV related outcomes are assessed in the primary analysis population (as defined by entry dried blood spot testing at screening) and compared between intervention and SOC arms.
|
60 weeks
|
|
Cumulative incidence of HCV reinfection following sustained virologic response (SVR4+) within 60 weeks of entry
Tijdsspanne: within 60 weeks
|
HCV related outcomes are assessed in the primary analysis population (as defined by entry dried blood spot testing at screening) and compared between intervention and SOC arms.
|
within 60 weeks
|
|
Cumulative retreatment following sustained virologic response (SVR4+) or relapse within 60 weeks of entry
Tijdsspanne: within 60 weeks
|
HCV related [all outcomes are assessed in the primary analysis population (as defined by dried blood spot testing at screening) and compared between intervention and SOC arms].
This analysis for retreatment is limited to participants 18 years old and older.
|
within 60 weeks
|
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Proportion of participants with HIV who commence direct-acting antiviral (DAA) therapy within 24 weeks of entry
Tijdsspanne: 24 weeks of entry
|
HIV related outcomes are assessed in the primary analysis population (as defined by entry dried blood spot testing at screening) and compared between intervention and SOC arms.
|
24 weeks of entry
|
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Proportion of participants with HIV not on antiretroviral therapy (ART) at screening who commence ART within 24 weeks of entry
Tijdsspanne: 24 weeks of entry
|
HIV related outcomes are assessed in the primary analysis population (as defined by entry dried blood spot testing at screening) and compared between intervention and SOC arms.
|
24 weeks of entry
|
|
Proportion of participants with HIV on antiretroviral therapy (ART) at screening who remain on ART at week 24 and week 60
Tijdsspanne: Week 24 and 60
|
HIV related [all outcomes are assessed in the primary analysis population (as defined by dried blood spot testing at screening) and compared between intervention and SOC arms].
|
Week 24 and 60
|
|
On direct-acting antiviral (DAA) treatment serious suspected adverse events leading to discontinuation of sofosbuvir/velpatasvir
Tijdsspanne: 60 weeks
|
Safety [all outcomes are assessed in the primary analysis population (as defined by dried blood spot testing at screening) and compared between intervention and SOC arms].
|
60 weeks
|
|
Adverse maternal and fetal outcomes for those on direct-acting antiviral (DAA) at any time during pregnancy
Tijdsspanne: up to 60 weeks
|
Safety [all outcomes are assessed in the primary analysis population (as defined by dried blood spot testing at screening) and compared between intervention and SOC arms].
|
up to 60 weeks
|
Andere uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Health-related quality of life (EQ5D) and social functioning through week 60
Tijdsspanne: Week 60
|
Week 60
|
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Changes in health-related quality of life (EQ5D) from baseline to week 24 and week 60
Tijdsspanne: from baseline to Week 24 and 60
|
from baseline to Week 24 and 60
|
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Among participants pregnant at time of enrollment: Proportion of participants completing DAA therapy within 24 weeks of entry and achieving SVR4+ within 60 weeks of entry
Tijdsspanne: Week 24 and 60
|
Week 24 and 60
|
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Adherence to direct-acting antiviral (DAA) therapy as measured by participant self-report
Tijdsspanne: 12 and 24 weeks
|
12 and 24 weeks
|
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Among participants pregnant at time of enrollment: Proportion of participants initiating direct-acting antiviral (DAA) therapy within 12 and 24 weeks of entry
Tijdsspanne: Weeks 12 and 24
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Weeks 12 and 24
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Susanna Naggie, MD, MHS, Duke University
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- Shrestha R, Karki P, Altice FL, Huedo-Medina TB, Meyer JP, Madden L, Copenhaver M. Correlates of willingness to initiate pre-exposure prophylaxis and anticipation of practicing safer drug- and sex-related behaviors among high-risk drug users on methadone treatment. Drug Alcohol Depend. 2017 Apr 1;173:107-116. doi: 10.1016/j.drugalcdep.2016.12.023. Epub 2017 Feb 2.
- Eckhardt B, Mateu-Gelabert P, Aponte-Melendez Y, Fong C, Kapadia S, Smith M, Edlin BR, Marks KM. Accessible Hepatitis C Care for People Who Inject Drugs: A Randomized Clinical Trial. JAMA Intern Med. 2022 May 1;182(5):494-502. doi: 10.1001/jamainternmed.2022.0170.
- Skarbinski J, Rosenberg E, Paz-Bailey G, Hall HI, Rose CE, Viall AH, Fagan JL, Lansky A, Mermin JH. Human immunodeficiency virus transmission at each step of the care continuum in the United States. JAMA Intern Med. 2015 Apr;175(4):588-96. doi: 10.1001/jamainternmed.2014.8180.
- Sherman SG, Schneider KE, Park JN, Allen ST, Hunt D, Chaulk CP, Weir BW. PrEP awareness, eligibility, and interest among people who inject drugs in Baltimore, Maryland. Drug Alcohol Depend. 2019 Feb 1;195:148-155. doi: 10.1016/j.drugalcdep.2018.08.014. Epub 2018 Oct 22.
- McFarland W, Lin J, Santos GM, Arayasirikul S, Raymond HF, Wilson E. Low PrEP Awareness and Use Among People Who Inject Drugs, San Francisco, 2018. AIDS Behav. 2020 May;24(5):1290-1293. doi: 10.1007/s10461-019-02682-7.
- Solomon SS, Wagner-Cardoso S, Smeaton L, Sowah LA, Wimbish C, Robbins G, Brates I, Scello C, Son A, Avihingsanon A, Linas B, Anthony D, Nunes EP, Kliemann DA, Supparatpinyo K, Kityo C, Tebas P, Bennet JA, Santana-Bagur J, Benson CA, Van Schalkwyk M, Cheinquer N, Naggie S, Wyles D, Sulkowski M. A minimal monitoring approach for the treatment of hepatitis C virus infection (ACTG A5360 [MINMON]): a phase 4, open-label, single-arm trial. Lancet Gastroenterol Hepatol. 2022 Apr;7(4):307-317. doi: 10.1016/S2468-1253(21)00397-6. Epub 2022 Jan 10.
- Sheehan Y, Cunningham EB, Cochrane A, Byrne M, Brown T, McGrath C, Lafferty L, Tedla N, Dore GJ, Lloyd AR, Grebely J. A 'one-stop-shop' point-of-care hepatitis C RNA testing intervention to enhance treatment uptake in a reception prison: The PIVOT study. J Hepatol. 2023 Sep;79(3):635-644. doi: 10.1016/j.jhep.2023.04.019. Epub 2023 Apr 26.
- Coyle C, Moorman AC, Bartholomew T, Klein G, Kwakwa H, Mehta SH, Holtzman D. The Hepatitis C Virus Care Continuum: Linkage to Hepatitis C Virus Care and Treatment Among Patients at an Urban Health Network, Philadelphia, PA. Hepatology. 2019 Aug;70(2):476-486. doi: 10.1002/hep.30501. Epub 2019 Mar 26.
- Mahase E. Hepatitis C: Egypt makes "unprecedented progress" towards elimination. BMJ. 2023 Oct 10;383:2353. doi: 10.1136/bmj.p2353. No abstract available.
- Dore GJ. Elimination of hepatitis C in Australia by 2030: a decade and counting. Aust Prescr. 2021 Apr;44(2):36-37. doi: 10.18773/austprescr.2021.003. Epub 2021 Apr 1. No abstract available.
- Eckhardt B, Kapadia SN, Mateu-Gelabert P, Pai M, Fong C, Aponte-Melendez Y, Marks KM. Rapid Treatment Initiation for Hepatitis C in Young People Who Inject Drugs: The Seek, Test, and Rapid Treatment Randomized Trial. Open Forum Infect Dis. 2022 May 7;9(7):ofac225. doi: 10.1093/ofid/ofac225. eCollection 2022 Jul.
- Brooks R, Wegener M, Freeman B, Fowles C, Madden LM, Tetrault JM, Nichols L, Altice FL, Villanueva M. Improving HIV and HCV Testing in Substance Use Disorder Programs (SUDs) That Provide Medications for Opiate Use Disorder (MOUD): Role of Addressing Barriers and Implementing Universal and Site-Specific Approaches. Health Promot Pract. 2023 Sep;24(5):1018-1028. doi: 10.1177/15248399231169791. Epub 2023 Jul 13.
- Sivakumar A, Madden L, DiDomizio E, Eller A, Villanueva M, Altice FL. Treatment of Hepatitis C virus among people who inject drugs at a syringe service program during the COVID-19 response: The potential role of telehealth, medications for opioid use disorder and minimal demands on patients. Int J Drug Policy. 2022 Mar;101:103570. doi: 10.1016/j.drugpo.2021.103570. Epub 2021 Dec 20.
- Westgard LK, Sato T, Bradford WS, Eaton EF, Pilcher F, Hale AJ, Singh D, Martin M, Appa AA, Meyer JP, Weimer MB, Barakat LA, Felsen UR, Akiyama MJ, Ridgway JP, Grussing ED, Thakarar K, White A, Mutelayi J, Krsak M, Montague BT, Nijhawan A, Balakrishnan H, Marks LR, Wurcel AG. National HIV and HCV Screening Rates for Hospitalized People who Use Drugs Are Suboptimal and Heterogeneous Across 11 US Hospitals. Open Forum Infect Dis. 2024 Apr 16;11(5):ofae204. doi: 10.1093/ofid/ofae204. eCollection 2024 May.
- Di Martino V, Rufat P, Boyer N, Renard P, Degos F, Martinot-Peignoux M, Matheron S, Le Moing V, Vachon F, Degott C, Valla D, Marcellin P. The influence of human immunodeficiency virus coinfection on chronic hepatitis C in injection drug users: a long-term retrospective cohort study. Hepatology. 2001 Dec;34(6):1193-9. doi: 10.1053/jhep.2001.29201.
- Escudero DJ, Lurie MN, Mayer KH, King M, Galea S, Friedman SR, Marshall BDL. The risk of HIV transmission at each step of the HIV care continuum among people who inject drugs: a modeling study. BMC Public Health. 2017 Jul 25;17(1):614. doi: 10.1186/s12889-017-4528-9.
- Trickey A, Fajardo E, Alemu D, Artenie AA, Easterbrook P. Impact of hepatitis C virus point-of-care RNA viral load testing compared with laboratory-based testing on uptake of RNA testing and treatment, and turnaround times: a systematic review and meta-analysis. Lancet Gastroenterol Hepatol. 2023 Mar;8(3):253-270. doi: 10.1016/S2468-1253(22)00346-6. Epub 2023 Jan 24.
- Batchelder AW, Heo M, Foley JD, Sullivan MC, Lum P, Pericot Valverde I, Taylor LE, Mehta SH, Kim AY, Norton B, Tsui JI, Feinberg J, Page K, Litwin AH; HERO Study Group. Shame and stigma in association with the HCV cascade to cure among people who inject drugs. Drug Alcohol Depend. 2023 Dec 1;253:111013. doi: 10.1016/j.drugalcdep.2023.111013. Epub 2023 Oct 31.
- Fleurence RL, Collins FS. A National Hepatitis C Elimination Program in the United States: A Historic Opportunity. JAMA. 2023 Apr 18;329(15):1251-1252. doi: 10.1001/jama.2023.3692.
- Hernandez-Con P, Wilson DL, Tang H, Unigwe I, Riaz M, Ourhaan N, Jiang X, Song HJ, Joseph A, Henry L, Cook R, Jayaweera D, Park H. Hepatitis C Cascade of Care in the Direct-Acting Antivirals Era: A Meta-Analysis. Am J Prev Med. 2023 Dec;65(6):1153-1162. doi: 10.1016/j.amepre.2023.06.016. Epub 2023 Jun 26.
- Bunting SR, Vidyasagar N, Wilson AP, Hazra A. Preexposure Prophylaxis (PrEP) for HIV Prevention at Outpatient Substance Use Treatment Facilities, United States, 2021. Am J Public Health. 2024 Aug;114(8):833-837. doi: 10.2105/AJPH.2024.307699. Epub 2024 May 30.
- Rosengren AL, Lelutiu-Weinberger C, Woodhouse EW, Sandanapitchai P, Hightow-Weidman LB. A Scoping Review of HIV Pre-exposure Prophylaxis Stigma and Implications for Stigma-Reduction Interventions for Men and Transwomen Who Have Sex with Men. AIDS Behav. 2021 Jul;25(7):2054-2070. doi: 10.1007/s10461-020-03135-2. Epub 2021 Jan 2.
- Falade-Nwulia O, Gicquelais RE, Astemborski J, McCormick SD, Kirk G, Sulkowski M, Thomas DL, Mehta SH. Hepatitis C treatment uptake among people who inject drugs in the oral direct-acting antiviral era. Liver Int. 2020 Oct;40(10):2407-2416. doi: 10.1111/liv.14634.
- Hall EW, Bradley H, Barker LK, Lewis KC, Shealey J, Valverde E, Sullivan P, Gupta N, Hofmeister MG. Estimating hepatitis C prevalence in the United States, 2017-2020. Hepatology. 2025 Feb 1;81(2):625-636. doi: 10.1097/HEP.0000000000000927. Epub 2024 May 13.
- Hagan H, Thiede H, Des Jarlais DC. Hepatitis C virus infection among injection drug users: survival analysis of time to seroconversion. Epidemiology. 2004 Sep;15(5):543-9. doi: 10.1097/01.ede.0000135170.54913.9d.
- Bromberg DJ, Mayer KH, Altice FL. Identifying and managing infectious disease syndemics in patients with HIV. Curr Opin HIV AIDS. 2020 Jul;15(4):232-242. doi: 10.1097/COH.0000000000000631.
- Bhandari R. HIV Preexposure Prophylaxis Among People With Substance Use Disorder-The Road Less Traveled. JAMA Netw Open. 2022 Jul 1;5(7):e2221352. doi: 10.1001/jamanetworkopen.2022.21352. No abstract available.
- Hodder SL, Feinberg J, Strathdee SA, Shoptaw S, Altice FL, Ortenzio L, Beyrer C. The opioid crisis and HIV in the USA: deadly synergies. Lancet. 2021 Mar 20;397(10279):1139-1150. doi: 10.1016/S0140-6736(21)00391-3. Epub 2021 Feb 19.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
1 augustus 2026
Primaire voltooiing (Geschat)
30 november 2030
Studie voltooiing (Geschat)
30 december 2030
Studieregistratiedata
Eerst ingediend
2 april 2026
Eerst ingediend dat voldeed aan de QC-criteria
23 april 2026
Eerst geplaatst (Werkelijk)
30 april 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
5 mei 2026
Laatste update ingediend die voldeed aan QC-criteria
30 april 2026
Laatst geverifieerd
1 april 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Door bloed overgedragen infecties
- Urogenitale ziekten
- Genitale ziekten
- Ziekten van het immuunsysteem
- Infecties
- RNA-virusinfecties
- Virusziekten
- Ziekten van het spijsverteringsstelsel
- Lever Ziekten
- Hepatitis, viraal, menselijk
- Overdraagbare ziekten
- Seksueel overdraagbare aandoeningen, viraal
- Seksueel overdraagbare aandoeningen
- Lentivirus-infecties
- Retroviridae-infecties
- Immunologische deficiëntie syndromen
- DNA-virusinfecties
- Langzame virusziekten
- Flaviviridae-infecties
- Hepadnaviridae-infecties
- Hepatitis
- HIV-infecties
- Verworven Immunodeficiëntie Syndroom
- Hepatitis B
- Hepatitis C
- Heterocyclische verbindingen, 1-ring
- Heterocyclische verbindingen
- Nucleïnezuren, nucleotiden en nucleosiden
- Pyrimidines
- Ribonucleotiden
- Nucleotiden
- Pyrimidine -nucleotiden
- Uridine Monofosfaat
- Uracil Nucleotiden
- Sofosbuvir
- Sofosbuvir-velpatasvir medicijncombinatie
- velpatasvir
Andere studie-ID-nummers
- Pro00118863
- 1U01AI195193 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
ONBESLIST
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Ja
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Ja
product vervaardigd in en geëxporteerd uit de V.S.
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .