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PRO-HEP study.


- candidate number11197
- NTR NumberNTR3305
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR23-feb-2012
- Secondary IDs 
- Public TitlePRO-HEP study.
- Scientific TitleTelaprevir plus Ribavirin for the treatment Of acute Hepatitis C in HIV-infected patients - study.
- ACRONYMPRO-HEP study
- hypothesisCombination therapy with telaprevir/ ribavirin is as effective as the current standard of care with peginterferon-alfa/ ribavirin for the treatment of acute Hepatitis C in HIV-infected individuals.
- Healt Condition(s) or Problem(s) studiedHIV-positive patients, Hepatitis C
- Inclusion criteria1. HIV-infected with an undetectable HIV-RNA for the preceding 6 months and on a stable anti-retroviral regimen during this period; the only anti-retroviral drugs allowed are either efavirenz of ritonavir boosted atazanavir in combination with tenofovir/emtricitabin;
2. Male sex since acute HCV is prevalent among MSM;
3. Diagnosed with an acute HCV defined as a positive HCV serology and/ or detectable HCV-RNA with negative serology and/ or HCV-RNA in the preceding 6 months;
4. HCV genotype 1a or 1b;
5. ALAT elevation > 2 times the upper limit of normal (ULN in the UMC Utrecht is 35);
6. Low baseline HCV-RNA viral load (i.e. below 800.000 IU/ml);
7. Start of therapy within 4 weeks after the diagnosis of acute HCV;
8. Age 18 to 65 years.
- Exclusion criteria1. Age under 18 years or above 65 years;
2. Co-infections with acute or chronic hepatitis A, B, D and E;
3. Patients who are unable to give informed consent due to other circumstances, like delirium at admission, severe psychiatric disease, without a legal representative;
4. Subjects who have changed their anti-retroviral regimen within the last 3 months prior to Day 1 (other than zidovudine (AZT), didanosine (ddI), stavudine (d4T), efavirenz, etravirine, nevirapine, and HIV protease inhibitors without the coadministration of ritonavir which may be substituted at least one month prior to Day 1) or had first initiated anti-retroviral therapy within the last 6 months of Day 1;
5. Subjects who received prior treatment for hepatitis C (including any investigational medication) other than herbal remedies, except those with known hepatotoxicity (which are exclusionary). All herbal remedies used for hepatitis C treatment must be discontinued before Day 1. Only silymarin (milk thistle) is allowed during the trial;
6. Fibroscan indicating severe fibrosis (F3) or cirrhosis (F4) or any other clinical sign of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy;
7. Any current evidence of substance abuse of alcohol, intravenous drugs, inhalational (not including marijuana), psychotropics, narcotics, cocaine use, prescription or over-the-counter drugs or a clinical diagnosis of polysubstance abuse (≥3 of the above substances) within 1 years of the Screening Visit;
8. Patients included in an opiate substitution program;
9. Laboratory Exclusion Criteria (more than 10% of the listed laboratory exclusion criterion value):
A. Hemoglobin <7 mmol/L for females and <8 mmol/L for males;
B. Neutrophils <1500/mm3 (blacks/African-Americans: <1200/mm3);
C. Platelets <100,000/mm3.
10. Any known pre-existing medical condition that could interfere with the subjectís participation in and completion of the trial, including but not limited to Central nervous system (CNS) trauma, Immunologically-mediated diseases, Chronic pulmonary diseases, Current or history of any clinically significant cardiac abnormalities, Active clinical gout within the last year, hematologic abnormalities, Organ transplants and Evidence of active or suspected malignancy;
11. Subjects who are pregnant or nursing. Subjects who intend to become pregnant during the trial period. Male subjects with partners who are, or intend to become, pregnant during the trial period;
12. Any other condition which, in the opinion of the Principal Investigator, would make the subject unsuitable for enrollment or could interfere with the subject participating in and completing the trial.
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupFactorial
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-jun-2012
- planned closingdate31-dec-2014
- Target number of participants8
- InterventionsTreatment with a combination of telaprevir and ribavirin for 24 weeks.
- Primary outcomeSVR defined as HCV-RNA undetectable 24 weeks after stopping of the 24-week intervention.
- Secondary outcome1. To evaluate the viral kinetics during the first 12 weeks of combination therapy in HIV-infected patients with acute HCV;
2. To evaluate the number of side effects during telaprevir/ ribavirin therapy.
- TimepointsFirst Patient First Visit (FPFV): July 30th 2012;
Last Patient First Visit (LPFV): December 30th 2013;
Last Patient Last Visit (LPLV): June 30th 2014.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. J.E. Arends
- CONTACT for SCIENTIFIC QUERIESDr. J.E. Arends
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Utrecht (UMCU)
- PublicationsN/A
- Brief summaryThe current standard of care for the treatment of an acute hepatitis C (HCV) infection in HIV-infected patients consists of a combination of pegylated interferon-alfa and ribavirin. However, this regimen is infamous for its side-effects. With the introduction of the HCV protease-inhibitors, new possibilities for the treatment of acute HCV in HIV-infected patients arise. The aim of this pilot trial is to investigate the efficacy of the combination of telaprevir and ribavirin for the treatment of acute HCV in HIV-infected patients. Therefore, a total of 8 patients will be recruited from our center to participate. The total duration will be 24 weeks. The primary endpoint of the study is the number of patients reaching a sustained virological response (i.e. undetectable HCV-RNA 24 weeks after discontinuation of treatment).
- Main changes (audit trail)
- RECORD23-feb-2012 - 4-mrt-2012


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