Real-life Security and Efficacy of DAA-based Therapy in HCV/HIV-Coinfected Patients
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ClinicalTrials.gov Identifier: NCT02057003 |
Recruitment Status : Unknown
Verified October 2016 by José A. Mira Escarti, Valme University Hospital.
Recruitment status was: Recruiting
First Posted : February 6, 2014
Last Update Posted : October 17, 2016
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The purpose of this study is to evaluate the efficacy and tolerability of DAA-based regimens in the clinical practice in HIV/HCV-coinfected patients.
Hypothesis: The efficacy and tolerability of DAA-based regimens in the clinical practice is different to what is observed in clinical trials in HIV/HCV-coinfected patients.
Condition or disease | Intervention/treatment |
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Hepatitis C, Chronic Human Immunodeficiency Virus | Drug: DAA against HCV |

Study Type : | Observational |
Estimated Enrollment : | 1000 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Security and Efficacy of Triple Therapy Including Direct-Acting Antivirals Against Chronic Hepatitis C Infection In HIV-Coinfected Patients In Real-Life Conditions: The Prospective HEPAVIR Cohort. |
Study Start Date : | January 2012 |
Estimated Primary Completion Date : | December 2020 |
Estimated Study Completion Date : | December 2020 |

Group/Cohort | Intervention/treatment |
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DAA-based therapy against HCV
HIV/HCV-coinfected patients who start therapy against HCV including one or more DAA
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Drug: DAA against HCV
Other Names:
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- Number of patients who achieve SVR to DAA-based therapy as measure of efficacy [ Time Frame: 18 months ]Achievement of SVR to DAA-based therapy in the clinical practice in patients with chronic hepatitis C and HIV coinfection.
- Number of patients who develop severe adverse events as measure of safety [ Time Frame: 18 months ]Development of severe adverse events related to DAA-based therapy in the clinical practice in patients with chronic hepatitis C and HIV coinfection.
- Number of patients who achieve SVR to a BOC-based regimen as compared to numbers of patients who achieve SVR to a TVR-based regimen. [ Time Frame: 18 months ]In order to compare TVR- and BOC-based therapy, the numbers of patients who achieve SVR to DAA-based therapy will be analyzed.
- Number of patients who reach undetectable HCV-RNA at week 4 of PI-based therapy as a measure of on-treatment response to therapy. [ Time Frame: 18 months ]
- Number of patients who develop adverse events during a BOC-based regimen as compared to numbers of patients who develop adverse events during a TVR-based regimen. [ Time Frame: 18 months ]In order to compare TVR- and BOC-based therapy, the numbers of patients who develop adverse events during either treatment will be analyzed.
- Number of patients who achieve SVR to an interferon-free regimen. [ Time Frame: 36 weeks ]The numbers of patients who achieve SVR to DAA-based therapy in absence of interferon will be analyzed.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- Older than 18 years
- HIV infection determined by enzymeimmunoassay and confirmed by Western Blot
- Naïve to treatment including a DAA
- Initiation of triple therapy including a DAA
- Written informed consent to participate in the study and to undergo genetic determinations
Exclusion Criteria:
- Pregnancy
- Any contraindication for the administration of peg-IFN, RBV or the respective DAA
- Patients who are not able to provide informed consent to participate in the study

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02057003
Contact: Karin Neukam, PhD | 0034955015799 | karin.neukam@gmail.com |
Spain | |
Valme University Hospital | Recruiting |
Seville, Spain, 41014 | |
Contact: Karin Neukam, PhD 0034955015799 karin.neukam@gmail.com | |
Contact: Juan A Pineda, MD 0034955015684 japineda@telefonica.net |
Principal Investigator: | Karin Neukam, PhD | Valme University Hospital |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | José A. Mira Escarti, MD, Valme University Hospital |
ClinicalTrials.gov Identifier: | NCT02057003 |
Other Study ID Numbers: |
HEPAVIR-DAA |
First Posted: | February 6, 2014 Key Record Dates |
Last Update Posted: | October 17, 2016 |
Last Verified: | October 2016 |
HIV hepatitis C virus sustained virologic response telaprevir boceprevir simeprevir sofosbuvir daclatasvir paritaprevir |
pegylated interferon ribavirin direct-acting antivirals dasabuvir ombitasvir ledipasvir velpatasvir grazoprevir elbasvir |
Hepatitis A Hepatitis C Acquired Immunodeficiency Syndrome HIV Infections Hepatitis C, Chronic Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Immunologic Deficiency Syndromes |
Immune System Diseases Lentivirus Infections Retroviridae Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Hepatitis, Chronic Sofosbuvir MK-5172 Ledipasvir Velpatasvir Simeprevir Antiviral Agents Anti-Infective Agents Protease Inhibitors |