Clinical Trial:

Chronic HCV with HIV co-infection study

Full Name

Chronic HCV: AI452-032- Phase 3 open label study evaluating the efficacy and safety of pegylated interferon lambda-1a, in combination with ribavirin and daclatasvir for treatment of chronic HCV infection with treatment naïve genotypes 1, 2, 3 or 4 in subjects co-infected with HIV (2_PRO00001088)

Description

Participants will be in the study for approximately 48-72 weeks. Participants will be assigned to 1 of 2 treatment groups depending on their HCV genotype. Those who have HCV genotype 2 or 3 and who have never taken any medications to control their hepatitis infection will be assigned to Group A. Those with HCV genotype 1 or 4 and who have never taken any medications to control their hepatitis infection will be assigned to Group B. Everyone in the study will receive the same three medications: Peginterferon lambda-1a (Lambda), ribavirin (RBV) and daclatasvir (DCV). Lambda is self-injected under the skin once a week (180 micrograms). Ribavirin will be taken by mouth twice daily with food. Ribavirin comes in 200 milligram tablets. Participants assigned to Group A will take a total dose of 800 milligrams of ribavirin. Those assigned to Group B will take 1000 milligrams if they weigh less than 165 pounds and 1200 milligrams if they weigh more than 75 pounds. Daclatasvir will be taken by mouth once daily. The dose will be 30, 60 or 90 milligrams. The dose is dependent on whether or not the participant is taking medications for their HIV infection, and what medications they are taking. The participant’s study doctor will advise them which dose to take. Daclatasvir will be taken for 12 weeks. The Lambda and ribavirin will be taken for either 24 or 48 weeks depending on which treatment group they were assigned. Group A participants will receive 12 weeks of treatment with Lambda, ribavirin and daclatasvir, followed by an additional 12 weeks of treatment with Lambda and ribavirin. Group B participants will receive 12 weeks of treatment with Lambda, ribavirin and daclatasvir, followed by 12 or 36 weeks of treatment with Lambda and ribavirin depending on how well the study medications control their HCV. In addition, there is an optional DNA sub-study. Participants can choose to donate blood to be stored for up to 15 years for use in pharmacogenetic research (the branch of pharmacology that examines the relation of genetic factors to variations in response to drugs).

Eligibility

Inclusion Criteria
  • Must be 18 years of age or older
  • Must not have any evidence of liver disease other than chronic HCV
  • Must not be infected with HIV-2
  • Women of childbearing potential must have a negative serum or urine pregnancy test 
  • Men who are partners of women of childbearing potential must use contraception, and the male subject must confirm that their female partners are not pregnant at the time of screening
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