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

Sponsor
Tehran University of Medical Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT03369327
Collaborator
RojanPharma Pharmaceutical Company (Other)
232
Enrollment
2
Locations
1
Arm
23
Actual Duration (Months)
116
Patients Per Site
5.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Drug: sofosbuvir and daclatasvir
 Phase 3

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
232 participants
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
Actual Study Start Date :
Jan 1, 2017
Actual Primary Completion Date :
Sep 1, 2018
Actual Study Completion Date :
Dec 1, 2018

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • Sovodak 30/400
  • Sovodak 60/400
  • Sovodak 90/400

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The sustained viral response rate [12 weeks after end of treatment]

      Qualitative hepatitis C virus RNA polymerase chain reaction

    Secondary Outcome Measures

    1. Adverse drug events [weeks 2, 4, 8, 12 and 24]

      Questionnaire

    Eligibility Criteria

    Criteria

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

    Locations

    Site City State Country Postal Code
    1 Shariati Hospital Tehran Iran, Islamic Republic of 14117
    2 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tehran University of Medical Sciences
    ClinicalTrials.gov Identifier:
    NCT03369327
    Other Study ID Numbers:
    • 95-04-159-34058
    First Posted:
    Dec 12, 2017
    Last Update Posted:
    Feb 20, 2019
    Last Verified:
    Dec 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    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
    Virus Diseases
    Hepatitis C
    Acquired Immunodeficiency Syndrome
    HIV Infections
    Hepatitis
    Immunologic Deficiency Syndromes
    Sofosbuvir

    Study Results

    No Results Posted as of Feb 20, 2019