Clinical Trials

MainTitle

Sofosbuvir and Daclatasvir for Treating Hepatitis C in 200 Patients Co-infected With Human Immunodeficiency Virus (HIV200)

This study has been completed
Sponsor
Tehran University of Medical Sciences

Collaborator
RojanPharma Pharmaceutical Company

Information provided by (Responsible Party)
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier
NCT03369327

First received: December 6, 2017
Last updated: February 19, 2019
Last Verified: December 2017
History of Changes
Purpose

Purpose

In a multi-center study 200 patients co-infected with hepatitis C virus (HCV) and human immunodeficiency virus (HIV) will be treated with a fixed-dose combination pill combined of 400 mg sofosbuvir and 30, 60, or 90 mg of daclatasvir - depending on the particular antiretroviral treatment (ART) being used by the patient. The treatment duration will be 12 weeks for subjects without cirrhosis and 24 weeks for those with cirrhosis.

Condition Intervention Phase
Hepatitis C Virus Infection, Response to Therapy of
Human Immunodeficiency Virus

Drug : sofosbuvir and daclatasvir
Phase 3

Study Type: Interventional
Study Design: Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of a Fixed-Dose Combination Pill of Sofosbuvir and Daclatasvir in Treating Hepatitis C in 200 Patients Co-infected With Human Immunodeficiency Virus

Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures

  • The sustained viral response rate [ Time Frame: 12 weeks after end of treatment ]
    Qualitative hepatitis C virus RNA polymerase chain reaction
Secondary Outcome Measures:
  • Adverse drug events [ Time Frame: weeks 2, 4, 8, 12 and 24 ]
    Questionnaire

Enrollment: 232
Study Start Date: January 1, 2017
Study Completion Date: December 1, 2018
Primary Completion Date: September 1, 2018 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: sofosbuvir/daclatasvir
Once daily fixed-dose combination pill of sofosbuvir and daclatasvir for 12 weeks if the patient is non cirrhotic and for 24 weeks if cirrhotic
Drug: sofosbuvir and daclatasvir
    Depending on the ART received by each patient one of the fixed-dose combination pills below will be used:
    • Daclatasvir 30 mg and sofosbuvir 400 mg
    • Daclatasvir 60 mg and sofosbuvir 400 mg
    • Daclatasvir 90 mg and sofosbuvir 400 mg

    Other Name:
    • Sovodak 30/400
    • Sovodak 60/400
    • Sovodak 90/400

    Detailed Description:

    To achieve the goal of elimination of hepatitis C in 2030 as set forward by the world health organization (WHO) a main group requiring treatment are subjects co-infected with HIV. These subjects offer a particular challenge as they are receiving ART which frequently interferes with hepatitis treatment. The number of pills they are already taking also limits the compliance of these patients.
    In order to evaluate the efficacy of a fixed-dose combination pill combined of 400 mg sofosbuvir and 30, 60, or 90 mg of daclatasvir - depending on the particular ART medicine being used by the patient - a multi-center study of 200 co-infected patients has been designed.
    The treatment duration will be 12 weeks for subjects without cirrhosis and 24 weeks for those with cirrhosis.
    The study is one of the pilots being run for hepatitis C elimination in Iran.

    Eligibility

    Eligibility

    Ages Eligible for Study: 12 Years to 75 Years  
    Sexes Eligible for Study: All  
    Accepts Healthy Volunteers: No  

    Criteria

    Inclusion Criteria:

    • Positive qualitative hepatitis C virus RNA test on two occasions at least 6 months apart
    • Positive human immunodeficiency virus test


    Exclusion Criteria:
    • Heart rate < 50/min,
    • Taking amiodarone
    • Renal failure

    contacts and locations

    Contacts and Locations

    Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

    Please refer to this study by its ClinicalTrials.gov identifier: NCT03369327

    Locations

    Iran, Islamic Republic of
    Shariati Hospital
    Tehran, Iran, Islamic Republic of, 14117
    Emam Hospital
    Tehran, Iran, Islamic Republic of

    Sponsors and Collaborators

    Tehran University of Medical Sciences
    RojanPharma Pharmaceutical Company

    Investigators

    Study Chair: Reza Malekzadeh Tehran University of Medical Sciences
    More Information

    More Information


    Responsible Party: Tehran University of Medical Sciences  
    ClinicalTrials.gov Identifier: NCT03369327   History of Changes  
    Other Study ID Numbers: 95-04-159-34058  
    Study First Received: December 6, 2017  
    Last Updated: February 19, 2019  
    Individual Participant Data    
    Plan to Share IPD: No  

    Studies a U.S. FDA-regulated Drug Product: No  
    Studies a U.S. FDA-regulated Device Product: No  

    Additional relevant MeSH terms:
    Hepatitis A
    Hepatitis C
    Acquired Immunodeficiency Syndrome
    HIV Infections
    Hepatitis
    Immunologic Deficiency Syndromes
    Virus Diseases
    Sofosbuvir

    ClinicalTrials.gov processed this data on June 01, 2020
    This information is provided by ClinicalTrials.gov.