Early Chronic Hepatitis C Clinical Trial
— DARE-COfficial title:
DAA Based Therapy for Recently Acquired Hepatitis C
To examine the safety and efficacy of response guided triple therapy (PEG-IFN, Ribavirin, Telaprevir) for the treatment of early chronic HCV infection.
| Status | Active, not recruiting |
| Enrollment | 20 |
| Est. completion date | February 2016 |
| Est. primary completion date | June 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 60 Years |
| Eligibility |
Inclusion Criteria: 1. Provision of written, informed consent. 2. HCV genotype 1 infection 3. Quantifiable HCV RNA at screening and baseline (>10,000 IU/ml) 4. Recent hepatitis C infection with an estimated duration of Infection >6 months and = 18 months defined as A) i) First anti-HCV antibody or HCV RNA positive within the previous 6 months and ii) Documented anti-HCV antibody negative or HCV RNA negative within the 24 months prior to anti-HCV antibody positive result OR B) i) First anti-HCV antibody or HCV RNA positive within the previous 6 months and ii) acute clinical hepatitis (jaundice or ALT> 10 X ULN) within the 12 months prior to first positive HCV antibody or HCV RNA with no other cause of acute hepatitis identifiable 5. Compensated liver disease (Child-Pugh A) 6. Negative pregnancy test at screening and 24 hours prior to the first dose of study drugs. 7. If heterosexually active, a female subject of childbearing potential and a nonvasectomized male subject who has a female partner of childbearing potential must agree to use 2 effective contraceptives from screening onwards until 6 months (female subject) or 7 months (male subject) after RBV therapy has ended. Note: Hormonal contraceptives may be continued but may not be reliable during telaprevir dosing and for 2 months following cessation of telaprevir. Therefore, subjects should agree to use 2 effective non-hormonal methods of contraception during telaprevir combination therapy and for 2 months after the last intake of telaprevir. As of two months after completion of telaprevir hormonal contraceptives can again be used as one of the two required effective methods of birth control. 8. Subject is judged to be medically stable on the basis of physical examination, medical history and vital signs. 9. Adequate English to provide written, informed consent and to provide reliable responses to the study interview Additional inclusion criteria for HIV positive individuals - Confirmed HIV infection > 6 months duration - CD4 > 200 cells/mm3 and HIV < 50 c/ml on stable ART at least 3 months prior to treatment - Or - CD4 >= 500 cells/mm3 and HIV VL < 100,000 not on ART - If on ART must be taking a regimen containing an accepted* combination of the following drugs: tenofovir ( TDF), lamivudine ( 3TC), emtricitabine (FTC), efavirenz (EFV), abacavir (ABC), raltegravir (RAL), etravirine (ETV), rilpivirine (RIL), ritonavir boosted atazanavir (r/ATZ) * Combination must be supported by current HIV treatment guidelines Exclusion Criteria: - Individuals considered by the study investigators to be unlikely to participate in intensive follow-up and/or unwilling to provide extra blood samples - Current injecting drug use (any injecting within previous 4 weeks) - Standard exclusions to Peg-interferon (PEG-IFN), Ribavirin (RBV) and Telaprevir (TPV) therapy |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Australia | Royal Adelaide Hospital | Adelaide | South Australia |
| Australia | St Vincent's Hospital | Sydney | New South Wales |
| Lead Sponsor | Collaborator |
|---|---|
| Kirby Institute | Janssen-Cilag Ltd. |
Australia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | SVR12 | Proportion of subjects achieving SVR 12 (negative qualitative HCV RNA 12 weeks after therapy completion) | 12 weeks post-treatment | No |
| Secondary | SVR24 | To evaluate the proportion of patients with undetectable HCV RNA 24 weeks after therapy completion (SVR24) | 24 weeks post-treatment | No |
| Secondary | Undetectable HCV RNA (ETR) | To evaluate the proportion of patients with undetectable HCV RNA at end of treatment (ETR) | Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C) | No |
| Secondary | Undetectable HCV RNA (weeks 1,2,3,4,5,6,8) | To evaluate the proportion of patients with undetectable HCV RNA at weeks 1, 2, 3, 4, 5, 6 and 8 of therapy. | Week 1,2,3,4,5,6 and 8 of therapy | No |
| Secondary | gene IL28B polymorphism | To examine treatment outcome by IL28B polymorphism | Baseline | No |
| Secondary | Baseline resistance-associated variants | To correlate the presence and frequency of baseline resistance-associated variants (RAVs) with the response of Telaprevir based therapy for early chronic HCV infection. | Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C) | No |
| Secondary | Resistance-associated variants | To examine the emergence of resistance-associated variants during telaprevir based therapy for early chronic infection | Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C) | No |
| Secondary | Indicators of toxicity (ALT, HB, Neutrophils, Platelets) | To evaluate indicators of toxicity (ALT, HB, Neutrophils, Platelets) during telaprevir based therapy | Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C) | Yes |
| Secondary | Plasma ribavirin levels and haemoglobin | To correlate plasma ribavirin levels with treatment outcome and changes in haemoglobin during therapy | Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C) | Yes |
| Secondary | CD4 and HIV RNA | In HIV positive participants to evaluate changes in CD4 counts and HIV RNA during telaprevir based therapy | Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C) | Yes |