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)

NCT02006745 | Completed Phase 3

• 1 other identifier: SSAT 052
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

HIV

Outcome Measures

Primary Outcomes (1)

• • 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

  24 weeks

Study Arms (2)

Ribavirin

OTHER

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

Drug: Ribavirin

Telaprevir

OTHER

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

Drug: Telaprevir

Interventions

Ribavirin DRUG

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

Also known as: PEG-IFN and weight-based ribavirin (RBV)

Ribavirin

Telaprevir 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).

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

Telaprevir

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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:
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• St Stephens Aids Trust: lead

Study Sites (1)

St Stephens AIDS Trust

London, SW10 9TH, United Kingdom

Location

MeSH Terms

Interventions

Ribavirin; telaprevir

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Mark Nelson, Dr

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2013
• First Posted: December 10, 2013
• Study Start: January 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: April 12, 2017

Record last verified: 2017-04

Locations

GB (1)