HIV Drug Switch Followed by HCV Therapy in HIV-HCV Co-Infection
NCT ID: NCT02660905
Last Updated: 2022-11-14
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
25 participants
Study Classification
INTERVENTIONAL
Study Start Date
2016-04-30
Study Completion Date
2018-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
This is an prospective open label pilot study conducted over 32 weeks.
A total of 25 eligible participants who are infected with HCV and HIV will be recruited from 2 Canadian HIV Trials Network (CTN) sites (Ottawa Hospital Research Institute and McGill University Health Centre)
This study is investigating the effectiveness of a combination of Elvitegravir/Cobicistat/Emtricitabine/ Tenofovir Alafenamide Single Tablet Regimen (E/C/F/TAF STR) for HIV treatment and Harvoni for HCV treatment.
This study will assess the effect that the study drug has on the metabolism of sugar, the changes in fat in the bloodstream, and other metabolic changes. Metabolism is the process your body uses to get or make energy from the food you eat.
This study may provide information on the impact of liver fibrosis (scarring of liver tissues) on metabolic changes before, during and after HCV antiviral therapy.
Drug-drug interactions (DDI) between E/C/F/TAF and LPV-SOF have been well evaluated and no clinically significant interactions have been identified.
A switch to E/C/F/TAF in the context of LPV-SOF HCV antiviral treatment preparation may be particularly beneficial because of its:
1. favorable side effect profile
2. once daily STR formulation
3. known DDI profile with LPV-SOF
4. neutral effect on liver fibrosis
5. improved kidney and bone safety profile with the use of TAF
Conduct of this study is justified as it:
1. Assesses a minimal pill count and dosing frequency strategy of co-treatment of HIV and HCV using well tolerated medications with an excellent safety profile and known DDI profile.
2. Provides additional safety data for TAF in the HIV-HCV co-infected population.
3. Quantifies adherence and identifies obstacles to full adherence in this population. There is a paucity of data related to DAA adherence in licensing studies.
4. Provides real-world safety and efficacy data to support the public funding for LPV-SOF DAA therapy in HIV-HCV co-infected populations.
5. Provides preliminary data on the immunologic and metabolic consequences of HCV clearance in HIV-HCV co-infection
6. As a pilot study, the information gathered will inform the feasibility of future clinical trials evaluating novel treatment strategies for HIV-HCV co-infected patients.
A total of 25 eligible participants who are infected with HCV and HIV will be recruited from 2 Canadian HIV Trials Network (CTN) sites (Ottawa Hospital Research Institute and McGill University Health Centre)
This study is investigating the effectiveness of a combination of Elvitegravir/Cobicistat/Emtricitabine/ Tenofovir Alafenamide Single Tablet Regimen (E/C/F/TAF STR) for HIV treatment and Harvoni for HCV treatment.
This study will assess the effect that the study drug has on the metabolism of sugar, the changes in fat in the bloodstream, and other metabolic changes. Metabolism is the process your body uses to get or make energy from the food you eat.
This study may provide information on the impact of liver fibrosis (scarring of liver tissues) on metabolic changes before, during and after HCV antiviral therapy.
Drug-drug interactions (DDI) between E/C/F/TAF and LPV-SOF have been well evaluated and no clinically significant interactions have been identified.
A switch to E/C/F/TAF in the context of LPV-SOF HCV antiviral treatment preparation may be particularly beneficial because of its:
1. favorable side effect profile
2. once daily STR formulation
3. known DDI profile with LPV-SOF
4. neutral effect on liver fibrosis
5. improved kidney and bone safety profile with the use of TAF
Conduct of this study is justified as it:
1. Assesses a minimal pill count and dosing frequency strategy of co-treatment of HIV and HCV using well tolerated medications with an excellent safety profile and known DDI profile.
2. Provides additional safety data for TAF in the HIV-HCV co-infected population.
3. Quantifies adherence and identifies obstacles to full adherence in this population. There is a paucity of data related to DAA adherence in licensing studies.
4. Provides real-world safety and efficacy data to support the public funding for LPV-SOF DAA therapy in HIV-HCV co-infected populations.
5. Provides preliminary data on the immunologic and metabolic consequences of HCV clearance in HIV-HCV co-infection
6. As a pilot study, the information gathered will inform the feasibility of future clinical trials evaluating novel treatment strategies for HIV-HCV co-infected patients.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 1 or 4 HCV and HIV-1 Co-infection
NCT02073656
Hepatitis C Virus
HIV
COMPLETED
PHASE3
Switch to Genvoya Followed by HCV Therapy With Epclusa Followed by Simplification of HIV Therapy With Biktarvy in Patients With HIV-HCV Co-Infected Subjects on Opioid Substitution Therapy
NCT03549312
HIV-1-infection
Hepatitis C, Chronic
Methadone Dependence
+6 more
UNKNOWN
PHASE4
Boceprevir in HIV-HCV Coinfected Patients Who Have Failed to a Previous Therapy With Peg-Interferon/Ribavirin
NCT01335529
HCV Coinfection
HIV-1 Infection
COMPLETED
PHASE2
Community-based Treatment of Chronic Hepatitis C Monoinfection and Coinfection With HIV in the District of Columbia
NCT02339038
HCV HIV
COMPLETED
PHASE4
Efficacy and Safety of Ledipasvir/Sofosbuvir, With or Without Ribavirin, in HCV Infected Participants Who Have Failed Prior Treatment With Sofosbuvir-based Therapies
NCT02600351
Hepatitis C Virus Infection
TERMINATED
PHASE3
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The availability of interferon (IFN)-free HCV Direct Acting Antiviral (DAA) antiviral therapy such as Ledipasvir-Sofosbuvir (LPV-SOF) allows for broad provision of treatment for populations living with HIV-HCV. Co-infected persons frequently have competing co-morbidities and are at risk for progressive liver disease which makes adherence and combined management of HIV and HCV challenging. Simple, safe, well tolerated regimens with few drug-drug interactions could be highly beneficial in ensuring success of HCV therapy in this population. With this is mind, the optimal management of antiretroviral therapy prior to initiating LPV-SOF treatment remains unclear.
E/C/F/TAF \[elvitegravir-cobicistat-emtricitabine-tenofovir alafenamide fumarate (TAF)\] will be assessed in this study because it is formulated as a single tablet which facilitates adherence by once daily dosing and reduced pill count. It is established to be affective at achieving and maintaining HIV virologic suppression. The safety profile of this HIV regimen is excellent. The E/C/F/TAF formulation assessed in this study will contain TAF. This formulation has been evaluated in HIV-infected populations and found to be of equivalent HIV antiviral activity and to have improved impact on renal and bone metabolism \[ref: David Wohl, Anton Pozniak, Melanie Thompson, Edwin DeJesus, Daniel Podzamczer, Jean-Michel Molina, Gordon Crofoot, Christian Callebaut, Hal Martin, Scott McCallister. Tenofovir Alafenamide (TAF) in a Single-Tablet Regimen in Initial HIV-1 Therapy. Conference on Retroviruses and Opportunistic Infections. 113LB. February 23-26, 2015, Seattle, Washington.\]. There is minimal safety data in HIV-HCV co-infection.
Drug-drug interactions (DDI) between HIV antiretrovirals and HCV antivirals remain a key obstacle to the safe and effective delivery. The DDI between E/C/F/TAF and LPV-SOF have been well evaluated and no clinically significant interactions have been identified.
A switch to E/C/F/TAF in the context of LPV-SOF HCV antiviral treatment preparation may be particularly beneficial because of its:
1. favorable side effect profile
2. once daily STR formulation
3. known DDI profile with LPV-SOF
4. neutral effect on liver fibrosis
5. improved kidney and bone safety profile with the use of TAF
Conduct of this study is justified as it:
1. Assesses a minimal pill count and dosing frequency strategy of co-treatment of HIV and HCV using well tolerated medications with an excellent safety profile and known DDI profile (Complera followed by LPV-SOF). Polypharmacy in the co-infected population remains a significant challenge to therapeutic success.
2. Provides additional safety data for TAF in the HIV-HCV co-infected population.
3. Quantifies adherence and identifies obstacles to full adherence in this population. There is a paucity of data related to DAA adherence in licensing studies.
4. Provides real-world safety and efficacy data to support the public funding for LPV-SOF DAA therapy in HIV-HCV co-infected populations.
5. Provides preliminary data on the immunologic and metabolic consequences of HCV clearance in HIV-HCV co-infection
6. As a pilot study, the information gathered will inform the feasibility of future clinical trials evaluating novel treatment strategies for HIV-HCV co-infected patients.
E/C/F/TAF \[elvitegravir-cobicistat-emtricitabine-tenofovir alafenamide fumarate (TAF)\] will be assessed in this study because it is formulated as a single tablet which facilitates adherence by once daily dosing and reduced pill count. It is established to be affective at achieving and maintaining HIV virologic suppression. The safety profile of this HIV regimen is excellent. The E/C/F/TAF formulation assessed in this study will contain TAF. This formulation has been evaluated in HIV-infected populations and found to be of equivalent HIV antiviral activity and to have improved impact on renal and bone metabolism \[ref: David Wohl, Anton Pozniak, Melanie Thompson, Edwin DeJesus, Daniel Podzamczer, Jean-Michel Molina, Gordon Crofoot, Christian Callebaut, Hal Martin, Scott McCallister. Tenofovir Alafenamide (TAF) in a Single-Tablet Regimen in Initial HIV-1 Therapy. Conference on Retroviruses and Opportunistic Infections. 113LB. February 23-26, 2015, Seattle, Washington.\]. There is minimal safety data in HIV-HCV co-infection.
Drug-drug interactions (DDI) between HIV antiretrovirals and HCV antivirals remain a key obstacle to the safe and effective delivery. The DDI between E/C/F/TAF and LPV-SOF have been well evaluated and no clinically significant interactions have been identified.
A switch to E/C/F/TAF in the context of LPV-SOF HCV antiviral treatment preparation may be particularly beneficial because of its:
1. favorable side effect profile
2. once daily STR formulation
3. known DDI profile with LPV-SOF
4. neutral effect on liver fibrosis
5. improved kidney and bone safety profile with the use of TAF
Conduct of this study is justified as it:
1. Assesses a minimal pill count and dosing frequency strategy of co-treatment of HIV and HCV using well tolerated medications with an excellent safety profile and known DDI profile (Complera followed by LPV-SOF). Polypharmacy in the co-infected population remains a significant challenge to therapeutic success.
2. Provides additional safety data for TAF in the HIV-HCV co-infected population.
3. Quantifies adherence and identifies obstacles to full adherence in this population. There is a paucity of data related to DAA adherence in licensing studies.
4. Provides real-world safety and efficacy data to support the public funding for LPV-SOF DAA therapy in HIV-HCV co-infected populations.
5. Provides preliminary data on the immunologic and metabolic consequences of HCV clearance in HIV-HCV co-infection
6. As a pilot study, the information gathered will inform the feasibility of future clinical trials evaluating novel treatment strategies for HIV-HCV co-infected patients.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Human Immunodeficiency Virus
Hepatitis C, Chronic
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Active Treatment
E/C/F/TAF Ledipasvir-Sofosbuvir/TAF
Group Type
EXPERIMENTAL
E/C/F/TAF;
Intervention Type
DRUG
Evaluation of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Switch followed by Ledipasvir-Sofosbuvir Antiviral HCV Therapy
Ledipasvir-Sofosbuvir
Intervention Type
DRUG
Evaluation of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Switch followed by Ledipasvir-Sofosbuvir Antiviral HCV Therapy
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
E/C/F/TAF;
Evaluation of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Switch followed by Ledipasvir-Sofosbuvir Antiviral HCV Therapy
Intervention Type
DRUG
Ledipasvir-Sofosbuvir
Evaluation of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Switch followed by Ledipasvir-Sofosbuvir Antiviral HCV Therapy
Intervention Type
DRUG
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Genvoya
emtricitabine/ rilpivirine/ tenofovir disoproxil fumarate
Harvoni
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* HIV infected (ELISA with western blot confirmation)
* HCV RNA positive for minimum of 6 months / Genotype 1
* Prescribed cART that may include any Department of Health and Human Services (DHHS) recommended or alternative regimens, which the treating physician considers, is appropriate for their patient. (We anticipate that approximately 60% will be on HIV protease inhibitor-based regimens).
* HIV RNA BLLQ for minimum of 3 months
* Stage 3 or 4 fibrosis
* No evidence of liver decompensation defined as past or current ascites, bleeding varices or hepatic encephalopathy. Prior interferon, ribavirin and/or HCV protease inhibitor exposure will be allowed with the exception of cirrhotic with a past history of null response to interferon-based therapy.
* Ability to remain adherent to medications and study protocol as per investigator opinion
* For female subjects, not pregnant, planning or suspected to be pregnant or breast-feeding
* Willing to use acceptable methods of birth control, as defined in protocol
* Active substance use and/or mental health issues will not be exclusionary assuming other criteria are met. This inclusion will be restricted to those stably housed and engaged in harm reduction strategies. Our intent is to evaluate study participants who are representative of our clinical population and consider 'difficult to cure' compared to populations already evaluated in licensing studies
* HCV RNA positive for minimum of 6 months / Genotype 1
* Prescribed cART that may include any Department of Health and Human Services (DHHS) recommended or alternative regimens, which the treating physician considers, is appropriate for their patient. (We anticipate that approximately 60% will be on HIV protease inhibitor-based regimens).
* HIV RNA BLLQ for minimum of 3 months
* Stage 3 or 4 fibrosis
* No evidence of liver decompensation defined as past or current ascites, bleeding varices or hepatic encephalopathy. Prior interferon, ribavirin and/or HCV protease inhibitor exposure will be allowed with the exception of cirrhotic with a past history of null response to interferon-based therapy.
* Ability to remain adherent to medications and study protocol as per investigator opinion
* For female subjects, not pregnant, planning or suspected to be pregnant or breast-feeding
* Willing to use acceptable methods of birth control, as defined in protocol
* Active substance use and/or mental health issues will not be exclusionary assuming other criteria are met. This inclusion will be restricted to those stably housed and engaged in harm reduction strategies. Our intent is to evaluate study participants who are representative of our clinical population and consider 'difficult to cure' compared to populations already evaluated in licensing studies
Exclusion Criteria
* Concomitant use of drugs with contraindication drug interactions with E/C/F/TAF of SOF-LDV
* History of HIV integrase inhibitors or NRTI resistance mutations
* Platelets \<50 x10\^9/L
* History of HIV integrase inhibitors or NRTI resistance mutations
* Platelets \<50 x10\^9/L
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Gilead Sciences
INDUSTRY
Sponsor Role
collaborator
CIHR Canadian HIV Trials Network
NETWORK
Sponsor Role
collaborator
Ottawa Hospital Research Institute
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Curtis Cooper, MD, FRCPC
Role: PRINCIPAL_INVESTIGATOR
The Ottawa Hospital; Ottawa Hospital Research Institute
Marina Klein, MD
Role: PRINCIPAL_INVESTIGATOR
McGill University Health Centre/Research Institute of the McGill University Health Centre
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The Ottawa Hospital, General Campus
Ottawa, Ontario, Canada
Site Status
The Research Institute of the McGill University Health Centre
Montreal, Quebec, Canada
Site Status
Countries
Review the countries where the study has at least one active or historical site.
Canada
References
Explore related publications, articles, or registry entries linked to this study.
Allison ME, Wreghitt T, Palmer CR, Alexander GJ. Evidence for a link between hepatitis C virus infection and diabetes mellitus in a cirrhotic population. J Hepatol. 1994 Dec;21(6):1135-9. doi: 10.1016/s0168-8278(05)80631-2.
Reference Type
BACKGROUND
Mavrogiannaki A, Karamanos B, Manesis EK, Papatheodoridis GV, Koskinas J, Archimandritis AJ. Prevalence of glucose intolerance in patients with chronic hepatitis B or C: a prospective case-control study. J Viral Hepat. 2009 Jun;16(6):430-6. doi: 10.1111/j.1365-2893.2009.01077.x. Epub 2009 Feb 6.
Reference Type
BACKGROUND
Grasso A, Malfatti F, De Leo P, Martines H, Fabris P, Toscanini F, Anselmo M, Menardo G. Insulin resistance predicts rapid virological response in non-diabetic, non-cirrhotic genotype 1 HCV patients treated with peginterferon alpha-2b plus ribavirin. J Hepatol. 2009 Dec;51(6):984-90. doi: 10.1016/j.jhep.2009.07.008. Epub 2009 Jul 23.
Reference Type
BACKGROUND
Poustchi H, Negro F, Hui J, Cua IH, Brandt LR, Kench JG, George J. Insulin resistance and response to therapy in patients infected with chronic hepatitis C virus genotypes 2 and 3. J Hepatol. 2008 Jan;48(1):28-34. doi: 10.1016/j.jhep.2007.07.026. Epub 2007 Oct 1.
Reference Type
BACKGROUND
Taura N, Ichikawa T, Hamasaki K, Nakao K, Nishimura D, Goto T, Fukuta M, Kawashimo H, Fujimoto M, Kusumoto K, Motoyoshi Y, Shibata H, Abiru N, Yamasaki H, Eguchi K. Association between liver fibrosis and insulin sensitivity in chronic hepatitis C patients. Am J Gastroenterol. 2006 Dec;101(12):2752-9. doi: 10.1111/j.1572-0241.2006.00835.x. Epub 2006 Oct 6.
Reference Type
BACKGROUND
Hung CH, Wang JH, Hu TH, Chen CH, Chang KC, Yen YH, Kuo YH, Tsai MC, Lu SN, Lee CM. Insulin resistance is associated with hepatocellular carcinoma in chronic hepatitis C infection. World J Gastroenterol. 2010 May 14;16(18):2265-71. doi: 10.3748/wjg.v16.i18.2265.
Reference Type
BACKGROUND
Baid S, Cosimi AB, Farrell ML, Schoenfeld DA, Feng S, Chung RT, Tolkoff-Rubin N, Pascual M. Posttransplant diabetes mellitus in liver transplant recipients: risk factors, temporal relationship with hepatitis C virus allograft hepatitis, and impact on mortality. Transplantation. 2001 Sep 27;72(6):1066-72. doi: 10.1097/00007890-200109270-00015.
Reference Type
BACKGROUND
Butt AA, Xiaoqiang W, Budoff M, Leaf D, Kuller LH, Justice AC. Hepatitis C virus infection and the risk of coronary disease. Clin Infect Dis. 2009 Jul 15;49(2):225-32. doi: 10.1086/599371.
Reference Type
BACKGROUND
Donadon V, Balbi M, Ghersetti M, Grazioli S, Perciaccante A, Della Valentina G, Gardenal R, Dal Mas M, Casarin P, Zanette G, Miranda C. Antidiabetic therapy and increased risk of hepatocellular carcinoma in chronic liver disease. World J Gastroenterol. 2009 May 28;15(20):2506-11. doi: 10.3748/wjg.15.2506.
Reference Type
BACKGROUND
Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. doi: 10.1056/NEJMoa012512.
Reference Type
BACKGROUND
Dai CY, Chuang WL, Ho CK, Hsieh MY, Huang JF, Lee LP, Hou NJ, Lin ZY, Chen SC, Hsieh MY, Wang LY, Tsai JF, Chang WY, Yu ML. Associations between hepatitis C viremia and low serum triglyceride and cholesterol levels: a community-based study. J Hepatol. 2008 Jul;49(1):9-16. doi: 10.1016/j.jhep.2008.03.016. Epub 2008 Apr 22.
Reference Type
BACKGROUND
Economou M, Milionis H, Filis S, Baltayiannis G, Christou L, Elisaf M, Tsianos E. Baseline cholesterol is associated with the response to antiviral therapy in chronic hepatitis C. J Gastroenterol Hepatol. 2008 Apr;23(4):586-91. doi: 10.1111/j.1440-1746.2007.04911.x. Epub 2007 May 13.
Reference Type
BACKGROUND
Petit JM, Benichou M, Duvillard L, Jooste V, Bour JB, Minello A, Verges B, Brun JM, Gambert P, Hillon P. Hepatitis C virus-associated hypobetalipoproteinemia is correlated with plasma viral load, steatosis, and liver fibrosis. Am J Gastroenterol. 2003 May;98(5):1150-4. doi: 10.1111/j.1572-0241.2003.07402.x.
Reference Type
BACKGROUND
Siagris D, Christofidou M, Theocharis GJ, Pagoni N, Papadimitriou C, Lekkou A, Thomopoulos K, Starakis I, Tsamandas AC, Labropoulou-Karatza C. Serum lipid pattern in chronic hepatitis C: histological and virological correlations. J Viral Hepat. 2006 Jan;13(1):56-61. doi: 10.1111/j.1365-2893.2005.00655.x.
Reference Type
BACKGROUND
Corey KE, Kane E, Munroe C, Barlow LL, Zheng H, Chung RT. Hepatitis C virus infection and its clearance alter circulating lipids: implications for long-term follow-up. Hepatology. 2009 Oct;50(4):1030-7. doi: 10.1002/hep.23219.
Reference Type
BACKGROUND
Tada S, Saito H, Ebinuma H, Ojiro K, Yamagishi Y, Kumagai N, Inagaki Y, Masuda T, Nishida J, Takahashi M, Nagata H, Hibi T. Treatment of hepatitis C virus with peg-interferon and ribavirin combination therapy significantly affects lipid metabolism. Hepatol Res. 2009 Feb;39(2):195-9. doi: 10.1111/j.1872-034X.2008.00439.x. Epub 2008 Nov 5.
Reference Type
BACKGROUND
Moucari R, Forestier N, Larrey D, Guyader D, Couzigou P, Benhamou Y, Voitot H, Vidaud M, Seiwert S, Bradford B, Zeuzem S, Marcellin P. Danoprevir, an HCV NS3/4A protease inhibitor, improves insulin sensitivity in patients with genotype 1 chronic hepatitis C. Gut. 2010 Dec;59(12):1694-8. doi: 10.1136/gut.2010.219089. Epub 2010 Sep 21.
Reference Type
BACKGROUND
Lucidarme D, Foucher J, Le Bail B, Vergniol J, Castera L, Duburque C, Forzy G, Filoche B, Couzigou P, de Ledinghen V. Factors of accuracy of transient elastography (fibroscan) for the diagnosis of liver fibrosis in chronic hepatitis C. Hepatology. 2009 Apr;49(4):1083-9. doi: 10.1002/hep.22748.
Reference Type
BACKGROUND
Matthews DR, Hosker JP, Rudenski AS, Naylor BA, Treacher DF, Turner RC. Homeostasis model assessment: insulin resistance and beta-cell function from fasting plasma glucose and insulin concentrations in man. Diabetologia. 1985 Jul;28(7):412-9. doi: 10.1007/BF00280883.
Reference Type
BACKGROUND
Hull MW, Rollet K, Moodie EE, Walmsley S, Cox J, Potter M, Cooper C, Pick N, Saeed S, Klein MB; Canadian Co-infection Cohort Study Investigators. Insulin resistance is associated with progression to hepatic fibrosis in a cohort of HIV/hepatitis C virus-coinfected patients. AIDS. 2012 Sep 10;26(14):1789-94. doi: 10.1097/QAD.0b013e32835612ce.
Reference Type
BACKGROUND
Moreno M, Bataller R. Cytokines and renin-angiotensin system signaling in hepatic fibrosis. Clin Liver Dis. 2008 Nov;12(4):825-52, ix. doi: 10.1016/j.cld.2008.07.013.
Reference Type
BACKGROUND
Yu JW, Sun LJ, Zhao YH, Kang P, Yan BZ. The effect of metformin on the efficacy of antiviral therapy in patients with genotype 1 chronic hepatitis C and insulin resistance. Int J Infect Dis. 2012 Jun;16(6):e436-41. doi: 10.1016/j.ijid.2012.02.004. Epub 2012 Apr 7.
Reference Type
BACKGROUND
Canadian Diabetes Association Clinical Practice Guidelines Expert Committee; Cheng AY. Canadian Diabetes Association 2013 clinical practice guidelines for the prevention and management of diabetes in Canada. Introduction. Can J Diabetes. 2013 Apr;37 Suppl 1:S1-3. doi: 10.1016/j.jcjd.2013.01.009. Epub 2013 Mar 26. No abstract available.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
20150881-01H
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Pilot Study to Assess Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-dose Combination in Treatment Experienced Subjects With Hepatitis C Virus (HCV) Genotype 1 - HIV Co-infection
NCT02125500
COMPLETED
PHASE2
A Phase 2b Evaluation of Daclatasvir/Sofosbuvir in Non-Cirrhotic Treatment Naive Subjects With Genotype 1, 2, 3 and 4 Chronic Hepatitis C Virus Coinfected With Human Immunodeficiency Virus (HIV-1)
NCT02556086
WITHDRAWN
PHASE2
Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Treatment-Naive and Treatment-Experienced Subjects With Chronic Genotype 4 or 5 HCV Infection
NCT02081079
COMPLETED
PHASE2
Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination Tablet With Ribavirin for 12 Weeks in Treatment-naive Adults With Chronic HCV Genotype 3 Infection
NCT02413593
COMPLETED
PHASE2
Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 8 Weeks in Subjects With Chronic Genotype 1 HCV and HIV-1 Co-infection
NCT02480387
COMPLETED
PHASE2
Sofosbuvir, Ribavirin, for the Treatment of Chronic Hepatitis C Virus Genotype 1 in HIV-Coinfected Patients Receiving Fixed Dose Co-formulation Emtricitabine/ Tenofovir/Cobicistat/Elvitegravir: A Pilot Study
NCT02220868
COMPLETED
PHASE4
Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed-Dose Combination (FDC) for 6 Weeks in Adults With Acute Genotype 1 or 4 Hepatitis C Virus (HCV) and Chronic Human Immunodeficiency Virus (HIV)-1 Co-Infection
NCT02457611
COMPLETED
PHASE2
Eliminating Hepatitis C Transmission by Enhancing Care and Treatment Among HIV Co-infected Individuals
NCT02786758
COMPLETED
Boceprevir-based Therapy to Rescue HCV Genotype 1/HBV Infected Patients Refractory to Combination Therapy
NCT02060058
COMPLETED
PHASE3
Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin in Participants With Chronic Genotype 1 HCV Who Participated in a Prior Gilead-Sponsored HCV Treatment Study
NCT01987453
COMPLETED
PHASE2
Efficacy and Safety of Sofosbuvir Containing Regimens for the Treatment of Chronic HCV Infection in Participants With Chronic Genotype 1, 2, 3, or 6 HCV Infection
NCT01826981
COMPLETED
PHASE2
An Efficacy and Safety Study of Grazoprevir (MK-5172) + Elbasvir (MK-8742) in the Treatment of Chronic Hepatitis C Virus in Participants Who Are Co-Infected With Human Immunodeficiency Virus:C-EDGE CO-INFXN (MK-5172-061)
NCT02105662
COMPLETED
PHASE3
HCV Evolution in HIV/HCV (Genotype 1) Coinfected Patients Treated With Fosamprenavir
NCT01222611
COMPLETED
PHASE4
Ledipasvir/Sofosbuvir Fixed-Dose Combination Plus Ribavirin in Participants With Chronic HCV With Advanced Liver Disease or Post-Liver Transplant
NCT02010255
COMPLETED
PHASE2
A Study of the Safety and Effectiveness of Simeprevir and Sofosbuvir for Patients With HIV and Hepatitis C
NCT02206932
WITHDRAWN
PHASE4
Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination ± Ribavirin in Cirrhotic Subjects With Chronic Genotype 1 HCV Infection
NCT01965535
COMPLETED
PHASE2
Randomised Study of Interferon-free Treatment for Recently Acquired Hepatitis C in PWID and People With HIV Coinfection.
NCT02625909
COMPLETED
PHASE3
Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Coinfection
NCT02480712
COMPLETED
PHASE3
HIV Patients With Chronic Hepatitis C Genotype 1 Infection Who Failed Previously to Peginterferon /Ribavirin
NCT01718301
TERMINATED
PHASE3
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin in Treatment-Experienced Subjects With Genotype 1 HCV Infection
NCT01768286
COMPLETED
PHASE3
HepNet Acute HCV IV - LDV/SOF FDC in Acute Genotype 1 Hepatitis C Virus Infection
NCT02309918
COMPLETED
PHASE2
A Phase 3 Study to Evaluate Combination Therapy With Daclatasvir and Sofosbuvir in the Treatment of HIV and Hepatitis C Virus Coinfection.
NCT02032888
COMPLETED
PHASE3
A Phase 2b, Safety and Efficacy Study of Boceprevir in Patients Coinfected With HIV and Hepatitis C (P05411 AM4)
NCT00959699
COMPLETED
PHASE2