Clinical Trial:

Chronic Hepatitis C with HIV co-infection study

Full Name

Chronic Hepatitis C with HIV co-infection/ AI444-216-A Phase 3 Evaluation of Daclatasvir Plus Sofosbuvir in Treatment-naïve and Treatment experienced Chronic Hepatitis C (Genotype 1, 2, 3, 4, 5, or 6) Subjects Coinfected with Human Immunodeficiency Virus (HIV)(2_PRO00001603)

Description

This research study will include patients who are infected with chronic hepatitis C (HCV) and human immunodeficiency virus (HIV). Patients who are treatment naïve (those who have never been previously treated with prescription anti-HCV medications) will be randomly assigned to receive either 8 or 12 weeks of daclatsvir plus sofosbuvir. Those patients who are treatment experienced (received prior prescription anti-HCV medications) will receive 12 weeks of combination therapy. After the 12 weeks of taking the study drugs, there will be 24 weeks of follow-up (post-treatment visits). There is a pharmacogenetic sub-study.

Eligibility

Inclusion Criteria
  • Must be greater than or equal to 18 years of age
  • Must have chronic hepatitis C genotypes 1, 2, 3, 4, 5, or 6 infection
  • Must not have any previous exposure to any interferon formulation or ribavirin
  • Must not have any previous exposure to any HCV direct acting antivirals
  • Must be co-infected with HIV-1
  • Women must not be breastfeeding
  • Must not have uncontrolled diabetes
Doctor(s) Running This Study

Specialties

  • Infectious Diseases
  • Internal Medicine

Area of focus i

  • Hepatitis Care
  • HIV Care
  • HIV Pre-exposure Prophylaxis (PrEP)
  • LGBTQ+ Patient Support
  • Transgender health

LVPG Cliniciani

Accepting New Patients