Clinical trial NCT02006745 (phase 3, status: completed)
Conditions: hiv
ICD codes: B20, Z71.7, O98.72, Z21, O98.73, R75, Z11.4
Drugs: ribavirin, telaprevir
SMILES: NC(=O)C1=NN(C=N1)[C@@H]1O[C@H](CO)[C@@H](O)[C@H]1O, [H][C@@]12CCC[C@]1([H])[C@H](N(C2)C(=O)[C@@H](NC(=O)[C@@H](NC(=O)C1=NC=CN=C1)C1CCCCC1)C(C)(C)C)C(=O)N[C@@H](CCC)C(=O)C(=O)NC1CC1
Eligibility criteria:

        Inclusion Criteria:

          -  1. Is male or female aged 18 years or above 2. Has signed the Informed Consent Form
             voluntarily 3. Documented current acute hepatitis C genotype 1 infection with
             detectable HCV-RNA (PCR-assay) with an estimated duration less than 24 weeks as
             defined below:

               1. HCV RNA positive AND

               2. Prior negative anti-HCV antibody or HCV RNA test within 6 months OR

               3. rise of liver transaminases above 2.5 x ULN within the past 6 months with prior
                  normal transaminases during the year before AND

               4. exclusion of other causes of acute hepatitis 4. Confirmed HIV infection 5.
                  Receiving a atazanavir- or efavirenz- or raltegravir-based ART regimen or able to
                  switch regimen to these agents with an undetectable HIV viral load for at least 3
                  months, or not receiving ART with no immediate plans to start ART during the
                  first 6 months of study 6. CD4 T cell count >200/µl at screening in patients
                  under ART, CD4 T cell count >500/µl at screening in patients without ART 7. If
                  female and of childbearing potential, is using effective birth control methods
                  (as agreed by the investigator) and is willing to continue practising these birth
                  control methods during the trial and for at least 4 months after the last dosage
                  of ribavirin (ie 4 months after week 12, 24 or 48, depending on study arm and
                  treatment response). Routine monthly pregnancy tests must also be performed
                  during this time. Note: Women who are postmenopausal for least 2 years, women
                  with total hysterectomy, and women who have a tubal ligation are considered of
                  non-childbearing potential 8. Heterosexually active male participants or their
                  female partners must use effective birth control methods (as agreed by the
                  investigator) during the trial and for at least 7 months after the last dosage of
                  ribavirin (ie 7 months after week 12, 24 or 48, depending on study arm and
                  treatment response).

        Exclusion Criteria:

          -  . HCV infection with non-1 genotype 2. Acute opportunistic infection requiring
             treatment 3. Malignancy requiring chemotherapy or radiotherapy 4. Active HBV infection
             (HBs Ag + with positive hepatitis B DNA) 5. Known autoimmune disease 6. Hepatic
             failure 7. History of ischaemic heart disease or other serious cardiac disease 8.
             Serious psychiatric disease which in the view of the investigator precludes the use of
             interferon 9. Haemoglobinopathy or severe anaemia of any cause 10. Serious abnormality
             on screening blood tests including, but not limited to: Hemoglobin <10g/dl, absolute
             neutrophil count <1000/mm3, platelets <90,000/mm3, creatinine clearance <60ml/min 11.
             If female, she is pregnant or breastfeeding 12. Known hypersensitivity to one of the
             trial drugs or its excipients 13. Other contraindicated concomitant treatment 14. Any
             condition (including drug/alcohol abuse), or laboratory results which in the
             investigators opinion, interfere with assessments or completion of the trial 15. Any
             other reason why, in the opinion of the investigator, the patient should not be
             enrolled in the trial.