Overview

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)

Status:
Completed
Trial end date:
2016-02-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
St Stephens Aids Trust
Treatments:
Interferons
Ribavirin
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.