Status:
COMPLETED
HCV-HIV Co-infected Patient Cohort in Thailand
Lead Sponsor:
Institut de Recherche pour le Developpement
Collaborating Sponsors:
Ministry of Health, Thailand
Conditions:
Hepatitis C Infection
HIV
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This is a study of HCV treatment using the standard regimen of pegylated-interferon plus ribavirin in HIV co-infected patients participating in the PHPT cohort study. The treatment will be implemented...
Detailed Description
Study Population Screening: HIV infected patients with a positive anti-HCV test will be approached for screening if they are at least 18 years old, participate in the PHPT cohort study, have evidence ...
Eligibility Criteria
Inclusion
- Evidence of chronic HCV infection for at least 6 months before study entry (at least one detectable HCV viral load, i.e. ≥17 IU/mL, with an antibody test positive at least 6 months before the HCV RNA load result)
- Fibrosis Stage F2-3-4 determined by transient elastography (Fibroscan or other similar equipment). During the first part of the study, priority will be given to patients with Fibrosis Stage F2-3.
- Negative pregnancy test (on the day of inclusion).
Exclusion
- Anemia and thrombocytopenia
- Severe liver damage, advanced stage cirrhosis or cancer
- Uncontrolled diabetes, Uncontrolled thyroid dysfunction
- Retinopathy
- Creatinine clearance \<50 mL/min (Cockcroft)
- Disease associated with the immune system
- Significant heart problems
- Severe neuropsychiatric conditions Contra-indication to study treatment (including pregnancy or lack of effective contraception in the participant or female partner)
- Other exclusion criteria related to the use of ribavirin and peg-interferon
- Any conditions that, in the investigator's judgment, may compromise the follow up.
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2018
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT02247440
Start Date
August 1 2014
End Date
January 1 2018
Last Update
June 3 2019
Active Locations (5)
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1
Sanpatong Hospital
San Pa Tong, Chiang Mai, Thailand, 50120
2
Nakornping Hospital
Chiang Mai, Thailand, 50180
3
Chiangrai Prachanukroh Hospital
Chiang Rai, Thailand, 57000
4
Chonburi Hospital
Chon Buri, Thailand, 20000