A study of the safety of BIT225 in combination with pegylated interferon and ribavirin in patients with hepatitis C virus and human immunodeficiency virus co-infection, who are naive to treatment with pegylated interferon and ribavirin, and whose HIV is currently well controlled by standard antiretroviral therapy.
- Conditions
- Hepatitis C Virus infection in patients co-infected with human immunodeficiency virus-1Infection - Other infectious diseasesOral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colonInfection - Acquired immune deficiency syndrome (AIDS / HIV)
- Registration Number
- ACTRN12612001189819
- Lead Sponsor
- Biotron Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 12
1. Males or females, aged 18 to 65 years.
2. Chronic hepatitis C infection (defined as persistent HCV infection as diagnosed by detection of HCV RNA in the blood at least 6 months from initial detection).
3. Serologic evidence of HCV infection by anti-HCV antibody test.
4. Documentation of HCV genotype 1, 2, or 3 at any time prior to entry. (Enrolment will be limited to 4 patients with genotype 1 and 8 patients with genotype 2 or 3).
5. HCV RNA of >/=100,000 IU/mL within 60 days of Entry.
6. HIV-1 infection, as documented by a rapid HIV test or any licensed ELISA test kit and confirmed by Western blot at any time prior to study entry. HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than rapid HIV and ELISA is acceptable as an alternative confirmatory test.
7. Currently receiving stable antiretroviral therapy (ART) for at least 6 months (defined as at least 2 nucleoside reverse transcriptase inhibitors (NRTI), non-nucleoside reverse transcriptase inhibitors (NNRTI), protease inhibitors (PI) boosted or un-boosted with ritonavir, or integrase inhibitors in combination). The same ART regimen will be continued for the duration of study treatment.
8. HIV-1 RNA less than 200 copies/mL within 60 days before Day 0.
9. CD4+ count >/= 350 cells/mm3 within 30 days before Day 0.
10. ALT (SGOT) and AST (SGPT) less than or equal to 10 times the upper limit of normal (ULN) and stable for at least one month; alkaline phosphatase (ALP) less than or equal to 5 times ULN within 60 days of Day 0.
11. For females of reproductive potential (defined as women who have not been post-menopausal for at least 24 consecutive months, i.e., who have had menses within the preceding 24 months, or women who have not undergone surgical sterilization), must have a negative serum or urine pregnancy test at Screening and within 24 hours of starting HCV standard of care treatment (IFN and RBV) on Day 0.
A negative serum or urine pregnancy test result is also required within 24 hours prior to the initiation of BIT225 treatment (Day 7).
12. All subjects must agree not to participate in a conception process (e.g., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization).
If participating in sexual activity that could lead to pregnancy, the subject must agree to use two reliable methods of contraception simultaneously while receiving study treatment and for 6 months after stopping study treatment.
A combination of TWO of the following methods MUST be used appropriately:
Condoms (male or female) with or without a spermicidal agent
Diaphragm or cervical cap with spermicide
Intrauterine device (IUD)
Hormonal-based contraception.
13. Subjects who are not of reproductive potential (women who have been post-menopausal for at least 24 consecutive months or have undergone hysterectomy, salpingotomy, and/or bilateral oophorectomy or men who have documented azoospermia) are eligible without requiring the use of contraceptives.
14. Provide written informed consent to participate in the study and be willing to comply with the study procedures.
15. Naive to therapy for HCV, including any IFN or RBV.
1. Patients who have received an investigational drug for HCV or HIV, HIV vaccine, immunomodulators (e.g. interleukins, interferons, cyclosporine), systemic cytotoxic chemotherapy, or other investigational therapy within 30 days prior to Day 0.
2. Positive results for Hepatitis B (Hepatitis B surface antigen or HBV DNA in subjects with isolated HBcAb, defined as negative HBsAg, negative HBsAb and positive HBcAb (acute or chronic hepatitis B)) at Screening.
3. Currently have any active AIDS defining illness (according to the CDC Surveillance Case Definition for HIV infection, AIDS-Defining Conditions, updated December 5, 2008).
4. History or presence of other evidence of a medical condition associated with chronic liver disease (e.g., chronic or acute hepatitis B, acute hepatitis A, hemochromatosis, autoimmune hepatitis, Wilson’s disease, Gilbert’s syndrome, homozygote alpha1-antitrypsin deficiency, alcoholic liver disease, and toxin exposures).
5. Bridging cirrhosis or cirrhosis confirmed on a liver biopsy obtained within the past 36 months as judged by a local pathologist.
Note: Patients with Metavir (or equivalent index) stage 3 fibrosis on a previous biopsy will require an abdominal ultrasound within 6 months of first dose showing no evidence of cirrhosis.
6. History or signs of decompensated liver disease manifested by presence of Child-Pugh class B or C, ascites, variceal bleeding, or hepatic encephalopathy, spontaneous bacterial peritonitis, or other clinical signs of portal hypertension or hepatic insufficiency.
7. History or other evidence of clinically significant renal disease.
8. Abnormal haematological and biochemical parameters within 60 days of Entry:
a. Absolute neutrophil count <1000/mm3
b. Haemoglobin <12 g/dL in females or 13 g/dL in males
c. Platelet count <150,000/mm3
d. International normalized ratio (INR) >1.5.
e. Total bilirubin outside of normal reference range
f. Creatinine > 1.5 mg/dL
Estimated creatinine clearance < 60 mL/minute at Screening, calculated using the Cockcroft-Gault formula.
9. Screening ECG QTcB value >/= 450 ms.
10. The consumption / administration of concomitant medication (prescribed, over-the-counter or complementary) at the time of the Screening visit listed as excluded medications. Any medication taken from 30 days prior to first dose through to the end of the participation in the study must be approved by the Biotron Medical Monitor in consultation with the Investigator.
11. Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
12. A positive result on urine screen for drugs of abuse at Screening which in the opinion of the Investigator should preclude them from participation in the study.
13. History of severe psychiatric disease, or depression which in the opinion of the Investigator could be exacerbated by IFN therapy. Uncontrolled or active depression or other psychiatric disorder such as untreated Grade >/=3 psychiatric disorder, Grade >/=3 disorder not amenable to medical intervention, or any hospitalization within the past 52 weeks that in the opinion of the site Investigator might preclude tolerability of study requirements.
14. Any prior suicide attempt.
15. History of immunologically mediated disease (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method