Hepatitis C Clinical Trial
— DAHHS-2Official title:
Grazoprevir (MK-5172)+ Elbasvir (MK-8742) for the Treatment of Acute Hepatitis C Genotype 1/4. The Dutch Acute HCV in HIV Study (DAHHS-2)
Verified date | April 2019 |
Source | Erasmus Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
New and recently EMA/FDA approved direct acting antiviral (DAA) combination therapies cure
95% or more of the patients chronically infected with HCV genotype 1 and 4. Grazoprevir
(MK-5172) and elbasvir (MK-8742) combination therapy is such a, albeit not yet EMA/FDA
approved combination DAA therapy.
It is likely that the synergistic effect of the host's immune response and antiviral therapy
when given during the first 6 months of HCV infection makes antiviral therapy during acute
HCV infection more effective. In this study the investigators would like to document that
treatment of acute HCV with grazoprevir (MK-5172), elbasvir (MK-8742) is effective and can
ben shortened from 12 to 8 weeks for HCV genotype 1 and 4 infection without substantial loss
in efficacy.
Study design and intervention:
Prospective open label interventional clinical trial in which 80 acute HCV genotype 1 or 4
patients co-infected with HIV will receive 8 weeks of grazoprevir and elbasvir (a once-daily
combination tablet).
Study population:
80 Adult HIV positive patients with an acute HCV genotype 1 or 4 infection from 10 HIV
treatment centers in the Netherlands and Belgium will be included.
Primary endpoint: Sustained viral response (SVR) 12 weeks after the end of therapy in ITT
study population (=genotype 1 and 4).
Status | Completed |
Enrollment | 80 |
Est. completion date | January 11, 2019 |
Est. primary completion date | April 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. HIV positive 2. Acute HCV genotype 1 or 4 infection (=26 weeks old at the baseline visit) Exclusion Criteria: 1. Not on cART and a CD4 <500 at the time of screening 2. Patients on cART for >6 months with a HIV viral load >400 copies 3. Disallowed co-medication that cannot be stopped or replaced 4. History of liver cirrhosis of any etiology. Inclusion of patients with a chronic well-controlled HBV (HBV-DNA <below the limit of detection) is allowed if fibroscan excludes >F1 fibrosis 5. Protease inhibitor based and NNRTI based cART regimens are not allowed. Therefore, the inability to switch to a HAART regimen consisting of 2 nucleoside/tide reverse transcriptase inhibitors and an allowed third agent which can be raltegravir (Isentress®) 400mg BID, dolutegravir (Tivicay) 50mg QD or rilpivirine 25mg QD. |
Country | Name | City | State |
---|---|---|---|
Belgium | Institute of Tropical Medicine Antwerp (ITG) | Antwerpen | |
Netherlands | Onze Lieve Vrouwe Gasthuis (OLVG) | Amsterdam | |
Netherlands | Slotervaart Hospital | Amsterdam | |
Netherlands | Rijnstate Hospital | Arnhem | |
Netherlands | University Medical Center Groningen (UMCG) | Groningen | |
Netherlands | Maastricht University Medical Center (MUMC) | Maastricht | |
Netherlands | Radbout University Medical Center | Nijmegen | |
Netherlands | Erasmus Medical Center (EMC) | Rotterdam | Zuid Holland |
Netherlands | Utrecht Medical University Center (UMCU) | Utrecht |
Lead Sponsor | Collaborator |
---|---|
Erasmus Medical Center |
Belgium, Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | SVR12 (Reinfection Not Considered Failure) | Sustained viral response (SVR) 12 weeks after the end of therapy in all patients who started treatment in which reinfections are not considered failure | 12 weeks | |
Secondary | SVR12 (Reinfection Equals Failure) | Sustained viral response (SVR) 12 weeks after the end of therapy in all patients who started treatment in which reinfections are considered failure | week 12 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03686722 -
Effect of Co-administration of Metformin and Daclatasvir on the Pharmacokinetis and Pharmacodynamics of Metformin
|
Phase 1 | |
Recruiting |
NCT04510246 -
Link Hepatitis C Notifications to Treatment in Tasmania
|
N/A | |
Completed |
NCT03413696 -
Effects of Health Literacy and HCV Knowledge on HCV Treatment Willingness in HIV-coinfected Patients
|
||
Completed |
NCT03118674 -
Harvoni Treatment Porphyria Cutanea Tarda
|
Phase 2 | |
Completed |
NCT03109457 -
Hepatitis C Virus Detection in Oral Squamous Cell Carcinoma
|
||
Completed |
NCT01458054 -
Effect of Omeprazole and Ritonavir on GSK2336805 Pharmacokinetics in Healthy Adults
|
Phase 1 | |
Completed |
NCT03740230 -
An Observational Study of Maviret (Glecaprevir/Pibrentasvir) for Korean Chronic Hepatitis C Genotypes 1 to 6 Patients According to the Standard for Re-examination of New Drugs
|
||
Completed |
NCT03426787 -
Helping Empower Liver and Kidney Patients
|
N/A | |
Completed |
NCT03627299 -
Renal Transplants in Hepatitis C Negative Recipients With Nucleic Acid Positive Donors
|
Phase 4 | |
Completed |
NCT00006301 -
Immune Response to Hepatitis C Virus
|
||
Active, not recruiting |
NCT03949764 -
The Kentucky Viral Hepatitis Treatment Study
|
Phase 4 | |
Completed |
NCT03365635 -
Administration of Zepatier (Grazoprevir Plus Elbasvir) in Chronic Hemodialysis (HD) Patients With Hepatitis C
|
Phase 4 | |
Recruiting |
NCT04405024 -
Pilot Study on the Feasibility of Systematic Hepatitis C Screening of Hospitalized Patients
|
N/A | |
Completed |
NCT04525690 -
Improving Inpatient Screening for Hepatitis C
|
N/A | |
Completed |
NCT04033887 -
Evaluation Study of RDTs Detecting Antibodies Against HCV
|
||
Withdrawn |
NCT04546802 -
HepATocellular Cancer Hcv Therapy Study
|
Phase 3 | |
Active, not recruiting |
NCT02961426 -
Strategic Transformation of the Market of HCV Treatments
|
Phase 2/Phase 3 | |
Completed |
NCT02705534 -
Sofosbuvir, Ledipasvir, Ribavirin for Hepatitis C Cirrhotics, Genotype 1
|
Phase 3 | |
Completed |
NCT02869776 -
Integrating HCV and HIV Screening During the Era of HIV Antigen Testing
|
N/A | |
Completed |
NCT02992184 -
PoC-HCV Genedrive Viral Detection Assay Validation Study
|
N/A |