NCT02006745CompletedPhase 3
Open Label, Randomised, Pilot Trial of Pegylated Interferon, Ribavirin & Telaprevir vs Pegylated Interferon & Ribavirin Alone in Response Guided Treatment of Acute Hepatitis C Genotype 1 Virus Infection in Patients With HIV-1 Co-infection
St Stephens Aids Trust1 site in 1 country20 target enrollmentStarted: January 2014Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- • Comparison of rates of sustained virologic response(SVR24) between treatment arms; defined as HCV RNA not detectable at 24 weeks after planned completion of therapy
Study Overview
Brief Summary
The purpose of the study is to explore the treatment of patients with acute hepatitis C infection (infection acquired within the last 6 months) who are also infected with human immunodeficiency virus (HIV).
Detailed Description
In this study, we will compare two treatment options for hepatitis C in patients who also have HIV infection, to see if there are any differences in the numbers of patients treated who successfully got rid of the hepatitis C virus when the treatment was complete. We will also compare how well the two treatment options are tolerated by the patients taking them.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Is male or female aged 18 years or above
- •Has signed the Informed Consent Form voluntarily
- •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:
- •HCV RNA positive AND
- •Prior negative anti-HCV antibody or HCV RNA test within 6 months OR
- •rise of liver transaminases above 2.5 x ULN within the past 6 months with prior normal transaminases during the year before AND
- •exclusion of other causes of acute hepatitis
- •Confirmed HIV infection
- •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
- •CD4 T cell count >200/µl at screening in patients under ART, CD4 T cell count >500/µl at screening in patients without ART
- •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
- •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
- •Acute opportunistic infection requiring treatment
- •Malignancy requiring chemotherapy or radiotherapy
- •Active HBV infection (HBs Ag + with positive hepatitis B DNA)
- •Known autoimmune disease
- •Hepatic failure
- •History of ischaemic heart disease or other serious cardiac disease
- •Serious psychiatric disease which in the view of the investigator precludes the use of interferon
- •Haemoglobinopathy or severe anaemia of any cause
- •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
- •If female, she is pregnant or breastfeeding
- •Known hypersensitivity to one of the trial drugs or its excipients
- •Other contraindicated concomitant treatment
- •Any condition (including drug/alcohol abuse), or laboratory results which in the investigators opinion, interfere with assessments or completion of the trial
- •Any other reason why, in the opinion of the investigator, the patient should not be enrolled in the trial.
Arms & Interventions
Ribavirin
Other
ARM 1: PEG-IFN and weight-based ribavirin (RBV)
Intervention: Ribavirin (Drug)
Telaprevir
Other
ARM 2: PEG-IFN and weight-based RBV plus telaprevir (TPV)
Intervention: Telaprevir (Drug)
Outcomes
Primary Outcomes
• Comparison of rates of sustained virologic response(SVR24) between treatment arms; defined as HCV RNA not detectable at 24 weeks after planned completion of therapy
Time Frame: 24 weeks
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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