NCT03369327

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
232

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 12, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

February 20, 2019

Status Verified

December 1, 2017

Enrollment Period

1.7 years

First QC Date

December 6, 2017

Last Update Submit

February 19, 2019

Conditions

Hepatitis C Virus Infection, Response to Therapy ofHuman Immunodeficiency Virus

Outcome Measures

Primary Outcomes (1)

  • The sustained viral response rate

    Qualitative hepatitis C virus RNA polymerase chain reaction

    12 weeks after end of treatment

Secondary Outcomes (1)

  • Adverse drug events

    weeks 2, 4, 8, 12 and 24

Study Arms (1)

sofosbuvir/daclatasvir

EXPERIMENTAL

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

Interventions

sofosbuvir and daclatasvirDRUG

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

Also known as: Sovodak 30/400, Sovodak 60/400, Sovodak 90/400
sofosbuvir/daclatasvir

Eligibility Criteria

Age12 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Heart rate \< 50/min,
  • Taking amiodarone
  • Renal failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Shariati Hospital

Tehran, 14117, Iran

Location

Emam Hospital

Tehran, Iran

Location

Related Publications (1)

  • Dehghan Manshadi SA, Merat S, Mohraz M, Rasoolinejad M, Sali S, Mardani M, Tabarsi P, Somi MH, Sedghi R, Tayeri K, Nikbin M, Karimi J, Sharifi AH, Kalantari S, Norouzi A, Merat D, Malekzadeh Z, Mirminachi B, Poustchi H, Malekzadeh R. Single-pill sofosbuvir and daclatasvir for treating hepatis C in patients co-infected with human immunodeficiency virus. Int J Clin Pract. 2021 Aug;75(8):e14304. doi: 10.1111/ijcp.14304. Epub 2021 May 17.

    PMID: 33930223DERIVED

MeSH Terms

Conditions

Hepatitis CAcquired Immunodeficiency Syndrome

Interventions

Sofosbuvirdaclatasvir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesHIV InfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Uridine MonophosphateUracil NucleotidesPyrimidine NucleotidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleotidesNucleic Acids, Nucleotides, and NucleosidesRibonucleotides

Study Officials

  • Reza Malekzadeh

    Tehran University of Medical Sciences

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2017

First Posted

December 12, 2017

Study Start

January 1, 2017

Primary Completion

September 1, 2018

Study Completion

December 1, 2018

Last Updated

February 20, 2019

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations

IR(2)