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Antivirus Therapy for Population with HIV, HCV and TB Co-infection Clinical Trial

Antivirus Therapy for Population with HIV, HCV and TB Co-infection Clinical Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-09000407
Enrollment
Unknown
Registered
2009-04-25
Start date
2008-10-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Population with HIV and HCV and TB

Interventions

A:PEG-IFN-alpha-2a, ribavirin capsules
B:HAART, PEG-IFN-alpha-2a, ribavirin capsules
C:HAART, PEG-IFN-alpha-2a, ribavirin capsules
D:HAART

Sponsors

Guangzhou 8th People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients between 18 and 65 years old; 2. Gender are not limited; 3. Patients with positive HIV antibody which is confirmed by confirmatory test (W.B); 4. Patients not receiving anti-HIV therapy; 5. Patients without uncontrolled opportunistic infections or AIDS-related malignancies; 6. Subjects must understand and signe informed consent form before any procudre related to this study and abide by the requirements of this study. 7. Patients between 18 and 65 years old; gender are not limited; 8. Serum anti-HCV antibody (+) and HCV-RNA >103copies/ml in study group; 9. Peripheral hemogram: WBC >=3*10^9/L; Neutrophil count >=1.5*10^9/L; Platelet count >=80*109/L; Hemoglobin > 80g /L; 10. Serum creatinine =60%; 13. Alpha-Fetalprotein <=100ng/ml; 14. Autoimmune antibody is negative; 15. Thyroid function is normal; 16. No contraindication to use of interferon; 17. Has not received anti-HCV therapy in the past six months; 18. Subjects must understand and signe informed consent form before any procudre related to this study, and abide by the requirements of this study.

Exclusion criteria

Exclusion criteria: 1. Patient in acute infection stage; 2. Woman in pregnancy or breast-feeding; 3. Patient with serum amylase> 2 times of thenormal upper limit; 4. Patient with serious neurological or psychiatric disease; 5. Patient with serum alanine aminotransferase (ALT)> 5 times of the normal upper limit or total bilirubin (TBIL)> 2.5 times of the normal upper limit; 6. Patient with uncontrolled diseases in kidney, heart (supraventricular arrhythmia, specific ST segment change), lungs, digestive system (acute or chronic pancreatitis, decompensated liver cirrhosis); 7. Patient has history of alcohol abuse or can not comply with the treatment protocol or has impact on the outcome of treatment; 8. HBsAg positive individuals; 9. Patient plans to receive or has received liver transplantation; 10. Patient who received other medication within previous 3 months or have received anti-HCV therapy and the duration of withdraw is less than 3 months; 11. Patient who is allergic to investigational medication; 12. Patient who's not appropriate to take part in this study in the opinion of the investigator; 13. Woman in pregnancy or breast-feeding; 14. Patient with serious neurological or psychiatric disease; 15. Patient with uncontrolled diseases in kidney, heart (supraventricular arrhythmia, specific ST segment change), lungs, digestive system (acute or chronic pancreatitis, decompensated liver cirrhosis), metabolite disease (diabetes, thyroid disease), autoimmune disease, or liver tumor; 16. Patient has history of alcohol abuse or can not comply with the treatment protocol or has impact on the outcome of treatment; 17. HBsAg positive individuals; 18. Patient plans to receive or has received liver transplantation; 19. Patient who received other medication within previous 3 months or have received anti-HCV therapy and the duration of withdraw is less than 3 months; 20. Patient who is allergic to investigational medication; 21. Patient who has poor compliance.

Design outcomes

Primary

MeasureTime frame
AST;HCV-RNA;

Secondary

MeasureTime frame
CD4+;ALT;

Countries

China

Contacts

Public ContactCai Weiping
caiwp@163.net+86 020 83710422

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026