Combating Related Epidemics in HCV (CREST)
30 de abril de 2026 atualizado por: 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.
Visão geral do estudo
Status
Ainda não está recrutando
Tipo de estudo
Intervencional
Inscrição (Estimado)
1280
Estágio
- Fase 4
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Diagnóstico
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: 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.
|
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.
Outros nomes:
|
|
Experimental: 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.
|
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.
Outros nomes:
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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
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.
Prazo: 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+).
|
24 weeks from study enrollment
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Time from enrollment to treatment initiation
Prazo: 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
Prazo: 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
|
|
Proportion of participants who have received any HIV test result within 24 weeks of entry
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
|
|
Adverse device effects related to study devices
Prazo: 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)
Prazo: Day 1
|
Proportion of participants initiating same-visit DAA treatment following enrollment (intervention arm only)
|
Day 1
|
|
Proportion of participants initiating direct-acting antiviral (DAA) therapy within 12 weeks of entry
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
|
|
Proportion of participants with HIV who commence direct-acting antiviral (DAA) therapy within 24 weeks of entry
Prazo: 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 not on antiretroviral therapy (ART) at screening who commence ART within 24 weeks of entry
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
|
Outras medidas de resultado
Medida de resultado |
Prazo |
|---|---|
|
Health-related quality of life (EQ5D) and social functioning through week 60
Prazo: Week 60
|
Week 60
|
|
Changes in health-related quality of life (EQ5D) from baseline to week 24 and week 60
Prazo: from baseline to Week 24 and 60
|
from baseline to Week 24 and 60
|
|
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
Prazo: Week 24 and 60
|
Week 24 and 60
|
|
Adherence to direct-acting antiviral (DAA) therapy as measured by participant self-report
Prazo: 12 and 24 weeks
|
12 and 24 weeks
|
|
Among participants pregnant at time of enrollment: Proportion of participants initiating direct-acting antiviral (DAA) therapy within 12 and 24 weeks of entry
Prazo: Weeks 12 and 24
|
Weeks 12 and 24
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Susanna Naggie, MD, MHS, Duke University
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de agosto de 2026
Conclusão Primária (Estimado)
30 de novembro de 2030
Conclusão do estudo (Estimado)
30 de dezembro de 2030
Datas de inscrição no estudo
Enviado pela primeira vez
2 de abril de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
23 de abril de 2026
Primeira postagem (Real)
30 de abril de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
5 de maio de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
30 de abril de 2026
Última verificação
1 de abril de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Infecções transmitidas pelo sangue
- Doenças urogenitais
- Doenças Genitais
- Doenças do sistema imunológico
- Infecções
- Infecções por vírus de RNA
- Doenças Virais
- Doenças do aparelho digestivo
- Doenças do Fígado
- Hepatite, Viral, Humana
- Doenças Transmissíveis
- Doenças Sexualmente Transmissíveis, Virais
- Doenças Sexualmente Transmissíveis
- Infecções por Lentivírus
- Infecções por Retroviridae
- Síndromes de Deficiência Imunológica
- Infecções por vírus de DNA
- Doenças de Vírus Lento
- Infecções por Flaviviridae
- Infecções Hepadnaviridae
- Hepatite
- Infecções por HIV
- Síndrome da Imunodeficiência Adquirida
- Hepatite B
- Hepatite C
- Compostos heterocíclicos, 1 anel
- Compostos heterocíclicos
- Ácidos nucleicos, nucleotídeos e nucleosídeos
- Pirimidinas
- Ribonucleotídeos
- Nucleotídeos
- Nucleotídeos de pirimidina
- Monofosfato de Uridina
- Nucleótidos de Uracilo
- Sofosbuvir
- Combinação de drogas sofosbuvir-anvelpatasvir
- velpatasvir
Outros números de identificação do estudo
- Pro00118863
- 1U01AI195193 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
INDECISO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Sim
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Sim
produto fabricado e exportado dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .