An Open Label Non-Randomized Dose Escalating Trial to Assess Safety and Tolerability of Alb-Interferon Alfa 2b Every Two Weeks With Ribavirin Among HIV/HCV Coinfected Individuals

1. Patient cannot be on other experimental therapies (including expanded access/compassionate use of antiretrovirals) during his/her participation in this protocol.

2. Patients cannot have used interferon or peginterferon previously for the treatment of hepatitis C.

3. Mixed genotypes (e.g., 1/2, 1/4). Mixed genotype 1a/1b will be enrolled.

4. Liver histology which, in the opinion of Clinical Center pathologist, is consistent with any other co-existent cause of chronic liver disease as defined as: chronic hepatitis B with positive HBsAg autoimmune hepatitis with a positive ANA greater than 1 unit or positive anti mitochondrial antibody greater than 1 unit; cholestatic disease with persistent elevation of alkaline phosphatase; primary biliary cirrhosis or sclerosing cholangitis; Wilson's disease; alpha-1-antitrypsin deficiency; steatohepatitis (alcoholic or non alcoholic) with marked steatosis, many Mallory bodies, or extensive zone 3 periportal fibrosis.

6. For patients with cirrhosis, a Child Turcotte Pugh score greater than 7.

7. PT-INR greater than 2 or history of hemophilia or known history of Vitamin K deficiency or use of anticoagulants.

8. Organ transplant recipient other than cornea or hair transplant.

9. Estimated Creatinine clearance (eGFR) less than 50 mL/min.

10. A serum alpha-fetoprotein level (greater than 20 ng/mL, unless the subject has a negative ultrasound before enrollment.

11. For patients with history of diabetes mellitus, a HbA1C less than or equal to 7.5% and for those with a fasting blood glucose level of greater than 140mg/dL, a HbA1C of less than or equal to 7.5%.

12. Coexisting neoplastic disease except for Kaposi's sarcoma, any non-metastatic skin cancer that has been resected, or non-metastatic cervical or anal cancer that has been resected.

13. Severe cardiac disease (Grade 3 or more congestive cardiac failure, symptomatic coronary artery disease, significant arrhythmias, uncontrolled hypertension).

14. Severe chronic pulmonary disease with functional impairment or a DLCO less than or equal to 50% at baseline.

15. Severe psychiatric disorder that would interfere with the adherence to protocol requirements.

16. Preexisting autoimmune disorders including inflammatory bowel diseases, psoriasis, and optic neuritis.

17. Preexisting uncontrolled seizure disorder defined as one episode of seizure within the past 2 years.

18. Chronic pancreatitis.

19. Severe retinopathy as determined by the ophthalmologist.

20. Hemoglobinopathy (e.g., Thalassemia, sickle cell disease).

21. Currently taking didanosine or d4T as part of antiretroviral regimen.

22. Direct bilirubin greater than or equal to 0.6 mg/dL.

23. Concurrent use of any immunosuppressive therapy, including systemic steroids (prednisone equivalent of greater than 10 mg/day) for a duration of six weeks or more within six months prior to enrollment.

24. Concurrent use of fluticasone and high dose ritonavir (600mg t.i.d).

25. Chronic viral hepatitis of any other etiology other than hepatitis C.

26. Active systemic infections other than hepatitis C and HIV.

27. Liver disease caused by reasons other than hepatitis C, like HBV, HDV, Wilson's disease, hemochromatosis, autoimmune hepatitis (ANA greater than 1 unit) except history of drug-associated hepatitis with discontinuation of the causative agent.

28. Hepatic mass suggestive of hepatocellular carcinoma as detected by ultrasound scan.

29. Alcohol or substance abuse within the past 6 months that potentially could interfere with patient compliance.

30. Concomitant use of amphetamines, barbiturates, cocaine, ganciclovir, isoniazid, opiates, pyrazinamide, rifabutin, rifampin/rifampicin, thalidomide, and theophylline.

31. History of esophageal varices.

32. Any systemic illness that will make it unlikely that the subject will be able to return to NIH for the required study visits.

33. Evidence of gastrointestinal malabsorption, chronic nausea, or vomiting.

34. Male partners of pregnant women.

35. Pregnant women.

36. Breastfeeding women.

37. Hypersensitivity to interferon products or ribavirin.

38. Received silymarin (milk thistle) or glycyrrhizin within 28 days prior to Day 0.

39. Received Sho-saiko-to (SST) within 28 days prior to Day 0.

40. Received any other experimental agent within 28 days prior to Day 0.

What this study is about