Open Label Trial of PEG-IFN, RBV & TVR vs. PEG-IFN & RBV Alone in Tx of HCV-1 in HIV-1 Co-infected Patients (CHAT)

NCT ID: NCT02006745

Last Updated: 2017-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2016-02-29

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.

Conditions

HIV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Ribavirin

ARM 1: PEG-IFN and weight-based ribavirin (RBV)

Group Type: OTHER

Ribavirin

Intervention Type: DRUG

24 weeks in those achieving RVR (undetectable HCV RNA at 4 weeks) or 48 weeks in those not achieving RVR

Telaprevir

ARM 2: PEG-IFN and weight-based RBV plus telaprevir (TPV)

Group Type: OTHER

Telaprevir

Intervention Type: DRUG

12 weeks in those achieving RVR, 24 weeks in those not achieving RVR (HCV RNA \>25 but \<1000 iU/mL at week 4) or 48 weeks in those not achieving RVR (HCV RNA \>1000 iU/mL at week 4).

Interventions

Ribavirin

24 weeks in those achieving RVR (undetectable HCV RNA at 4 weeks) or 48 weeks in those not achieving RVR

Intervention Type: DRUG

Telaprevir

12 weeks in those achieving RVR, 24 weeks in those not achieving RVR (HCV RNA \>25 but \<1000 iU/mL at week 4) or 48 weeks in those not achieving RVR (HCV RNA \>1000 iU/mL at week 4).

Intervention Type: DRUG

Other Intervention Names

PEG-IFN and weight-based ribavirin (RBV); -ARM 2: PEG-IFN and weight-based RBV plus telaprevir (TPV)

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St Stephens Aids Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Nelson, Dr

Role: PRINCIPAL_INVESTIGATOR

St Stephens AIDS Trust, St Stephens Centre, Chelsea and Westminster Hospital, 369 Fulham Road, London, SW10 9EL

Locations

St Stephens AIDS Trust

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

SSAT 052

Identifier Type: -

Identifier Source: org_study_id