Foscenvivint in HIV/HCV co-infected adults with liver cirrhosis and hemophilia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, single-arm Phase 2 trial evaluating weekly intravenous foscenvivint over 24 weeks in adults with Child-Pugh A-B liver cirrhosis caused by HIV/HCV co-infection and hemophilia. Eligible participants must have controlled HIV, prior SVR to HCV, and evidence of cirrhosis, then receive follow-up at 4 weeks after the last dose. The study will monitor safety and preliminary efficacy, with ongoing assessments during treatment and after completion. Results will inform whether this approach merits further investigation in this specific comorbidity profile.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients with hemophilia and liver cirrhosis caused by HIV/HCV co-infection who meet both of the following criteria:

  1. Patients who are serum HIV-RNA positive or HIV antibody positive, with HIV-RNA maintained at \<200 copies/mL and a CD4-positive T lymphocyte count of ≥200 cells/µL at screening.
  2. Patients with HCV infection who have achieved sustained virologic response (SVR) at least 12 months before registration.

     * Patients with Child-Pugh class A or B liver cirrhosis (Child-Pugh score 5-9).
     * Patients who meet at least one of the following criteria for the diagnosis of liver cirrhosis:

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  1. Liver stiffness measurement by FibroScan of ≥12.5 kPa, corresponding to fibrosis stage F4, at screening.
  2. Abdominal CT showing changes in liver morphology and/or findings suggestive of portal hypertension.

     * Patients with an Eastern Cooperative Oncology Group Performance Status of 0-2.

Exclusion Criteria:

* Patients with liver cirrhosis caused by etiologies other than HCV or of unknown etiology.
* Patients with esophageal or gastric varices judged by endoscopic examination at screening to require treatment.
* Patients with current malignancy or a history of malignancy within 3 years before registration.
* Patients who have undergone liver transplantation or other organ transplantation, including bone marrow transplantation.
* Patients with active AIDS-defining disease requiring treatment. -

Where it's running

• Hokkaido University Hospital
  Sapporo, Hokkaido, Japan Recruiting
• National Hospital Organization Sendai Medical Center
  Sendai, Miyagi, Japan Recruiting
• National Hospital Organization Osaka National Hospital
  Osaka, Osaka, Japan Recruiting
• Tokyo Metropolitan Komagome Hospital
  Bunkyo-Ku, Tokyo, Japan Recruiting

Study contacts

• Principal investigator: Kiminori Kimura, MD — Tokyo Metropolitan Komagome Hospital
• Study coordinator: Kiminori Kimura, MD
• Email: kiminori_kimura@tmhp.jp
• Phone: +81-3-3823-2101

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.