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NCT Number: NCT03369327

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

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.

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Key information

Conditions

Hepatitis C Virus Infection, Response to Therapy of Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Genital Diseases HIV Infections Hepatitis Hepatitis C Hepatitis, Viral, Human Human Immunodeficiency Virus Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Liver Diseases RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

12 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Emam Hospital, Tehran, Iran

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sofosbuvir and daclatasvir

Drug

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

Primary outcomes

  1. The sustained viral response rate

    Time frame: 12 weeks after end of treatment

    Qualitative hepatitis C virus RNA polymerase chain reaction

Secondary outcomes

  1. Adverse drug events

    Time frame: weeks 2, 4, 8, 12 and 24

    Questionnaire

Sponsors and collaborators

Lead sponsor

Tehran University of Medical Sciences

Other

Collaborators

  • RojanPharma Pharmaceutical Company

Registry information

Official study 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

Acronym: HIV200

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 12, 2017
Registry last updated
Feb 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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