An Open Label Trial of Pegylated Interferon, Ribavirin and Telaprevir Versus Pegylated Interferon and Ribavirin Alone in the Treatment of Hepatitis C Genotype 1 Virus Infection in Patients With HIV-1 Co-infection (CHAT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by St Stephens Aids Trust
Sponsor:
Information provided by (Responsible Party):
St Stephens Aids Trust
ClinicalTrials.gov Identifier:
NCT02006745
First received: December 5, 2013
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

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).


Condition Intervention Phase
HIV
Drug: Ribavirin
Drug: Telaprevir
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: An Open Label, Randomised, Pilot Trial of Pegylated Interferon, Ribavirin and Telaprevir Versus Pegylated Interferon and Ribavirin Alone in the Response Guided Treatment of Acute Hepatitis C Genotype 1 Virus Infection in Patients With HIV-1 Co-infection

Resource links provided by NLM:


Further study details as provided by St Stephens Aids Trust:

Primary Outcome Measures:
  • • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: January 2014
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Ribavirin
ARM 1: PEG-IFN and weight-based ribavirin (RBV)
Drug: Ribavirin
24 weeks in those achieving RVR (undetectable HCV RNA at 4 weeks) or 48 weeks in those not achieving RVR
Other Name: PEG-IFN and weight-based ribavirin (RBV)
Telaprevir
ARM 2: PEG-IFN and weight-based RBV plus telaprevir (TPV)
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).
Other Name: -ARM 2: PEG-IFN and weight-based RBV plus telaprevir (TPV)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02006745

Locations
United Kingdom
St Stephens AIDS Trust Recruiting
London, United Kingdom, SW10 9TH
Contact: Carl Fletcher, Mr    020 3315 6563    carl.fletcher@chelwest.nhs.uk   
Contact: Chris Higgs , Mr    020 3315 6149    chris.higgs@chelwest.nhs.uk   
Principal Investigator: Mark Neslon, Dr         
Sponsors and Collaborators
St Stephens Aids Trust
Investigators
Principal Investigator: Mark Nelson, Dr St Stephens AIDS Trust, St Stephens Centre, Chelsea and Westminster Hospital, 369 Fulham Road, London, SW10 9EL
  More Information

No publications provided

Responsible Party: St Stephens Aids Trust
ClinicalTrials.gov Identifier: NCT02006745     History of Changes
Other Study ID Numbers: SSAT 052
Study First Received: December 5, 2013
Last Updated: April 10, 2014
Health Authority: United Kingdon: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Hepatitis
Hepatitis C
Virus Diseases
Coinfection
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Flaviviridae Infections
RNA Virus Infections
Infection
Parasitic Diseases
Interferons
Ribavirin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 01, 2014