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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03369327
Recruitment Status : Completed
First Posted : December 12, 2017
Last Update Posted : February 20, 2019
Sponsor:
Collaborator:
RojanPharma Pharmaceutical Company
Information provided by (Responsible Party):
Tehran University of Medical Sciences

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
Hepatitis C Virus Infection, Response to Therapy of Human Immunodeficiency Virus 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 232 participants
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 : January 1, 2017
Actual Primary Completion Date : September 1, 2018
Actual Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine


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:

  1. Daclatasvir 30 mg and sofosbuvir 400 mg
  2. Daclatasvir 60 mg and sofosbuvir 400 mg
  3. Daclatasvir 90 mg and sofosbuvir 400 mg
Other Names:
  • Sovodak 30/400
  • Sovodak 60/400
  • Sovodak 90/400




Primary Outcome Measures :
  1. The sustained viral response rate [ Time Frame: 12 weeks after end of treatment ]
    Qualitative hepatitis C virus RNA polymerase chain reaction


Secondary Outcome Measures :
  1. Adverse drug events [ Time Frame: weeks 2, 4, 8, 12 and 24 ]
    Questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 75 Years   (Child, Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03369327


Locations
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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
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Study Chair: Reza Malekzadeh Tehran University of Medical Sciences

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Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT03369327    
Other Study ID Numbers: 95-04-159-34058
First Posted: December 12, 2017    Key Record Dates
Last Update Posted: February 20, 2019
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Acquired Immunodeficiency Syndrome
HIV Infections
Hepatitis
Immunologic Deficiency Syndromes
Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Sofosbuvir
Antiviral Agents
Anti-Infective Agents