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

Human Immunodeficiency Virus Clinical Trial

— HIV200  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03369327
• Other study ID #: 95-04-159-34058
• Status: Completed
• Phase: Phase 3
• Start date: January 1, 2017
• Est. completion date: December 1, 2018

Study information

• Verified date: December 2017
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 232
• Est. completion date: December 1, 2018
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C Virus Infection, Response to Therapy of
• HIV Infections
• Human Immunodeficiency Virus
• Immunologic Deficiency Syndromes
• Virus Diseases

Intervention

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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Emam Hospital	Tehran
Iran, Islamic Republic of	Shariati Hospital	Tehran

Sponsors (2)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences	RojanPharma Pharmaceutical Company

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The sustained viral response rate	Qualitative hepatitis C virus RNA polymerase chain reaction	12 weeks after end of treatment
Secondary	Adverse drug events	Questionnaire	weeks 2, 4, 8, 12 and 24