Sofosbuvir and Daclatasvir for Treating Hepatitis C in 200 Patients Co-infected With Human Immunodeficiency Virus (HIV200)
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|ClinicalTrials.gov Identifier: NCT03369327|
Recruitment Status : Completed
First Posted : December 12, 2017
Last Update Posted : February 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C Virus Infection, Response to Therapy of Human Immunodeficiency Virus||Drug: sofosbuvir and daclatasvir||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||232 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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:
- The sustained viral response rate [ Time Frame: 12 weeks after end of treatment ]Qualitative hepatitis C virus RNA polymerase chain reaction
- Adverse drug events [ Time Frame: weeks 2, 4, 8, 12 and 24 ]Questionnaire
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
|Iran, Islamic Republic of|
|Tehran, Iran, Islamic Republic of, 14117|
|Tehran, Iran, Islamic Republic of|
|Study Chair:||Reza Malekzadeh||Tehran University of Medical Sciences|