Peg-IFN, RBV and telaprevir vs Peg-IFN and RBV alone in patients with acute hepatitis C and HIV co-infectio
- Conditions
- Acute hepatitis C infectionTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2012-005525-75-GB
- Lead Sponsor
- St Stephen's AIDS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 24
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:
a. HCV RNA positive AND
b. Prior negative anti-HCV antibody or HCV RNA test within 6 months OR
c. Rise of liver transaminases above 2.5 x ULN within the past 6 months with prior normal transaminases during the year before AND
d. 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).
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
1. 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 <90000/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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method