Open Label Phase II/III, Multicenter, Trial to Assess the Efficacy, Safety, Tolerance, and Pharmacokinetics of Sofosbuvir Plus Ravidasvir in HCV (+/- HIV) Chronically Infected Adults With no or Compensated Cirrhosis in Thailand and Malaysia

Who is this study for? Hepatitis C virus with or without HIV chronically infected adults with no or compensated cirrhosis in Thailand and Malaysia
What treatments are being studied? Sofosbuvir+Ravidasvir
Status: Active, not recruiting
Location: See all (13) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3

This is a Phase II/III, multicenter, multi-country, trial to assess the efficacy, safety, tolerance and pharmacokinetics of sofosbuvir plus ravidasvir for the treatment of HCV infection.

Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 69
Healthy Volunteers: No

• Evidence of chronic HCV infection, defined as: Positive anti-HCV antibody or detectable HCV RNA or HCV genotype at least 6 months before screening and HCV viral load ≥10^4 IU/mL at the time of screening / In subjects without documented HCV test results 6 months before screening, chronic hepatitis C infection can be assumed if risk exposures occurred > 6 months prior to screening and HCV viral load ≥10^4 IU/mL at the time of screening.

• Willing and able to provide written informed consent.

• Men and women age ≥ 18 years and < 70 years.

• Body Mass Index (BMI) of 18 to 35 kg/m2.

• Intention to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments.

• Women with a negative pregnancy test at screening and baseline.

• Women of child bearing potential who accept a highly effective contraceptive method from at least 2 weeks prior to study day 1 until 1-month post-treatment. A woman is of non-child bearing potential if she (a) reached natural menopause determined retrospectively after 12 months of amenorrhea without any other obvious medical cause or (b) had procedures like bilateral tubal ligation or hysterectomy or bilateral oophorectomy.

• Subjects who are compliant in an opioid substitution maintenance program (e.g. with methadone or buprenorphine) may be included as long as there is no concern about study medications adherence and interaction or compliance to study schedules.

• HIV/HCV co-infected patients receiving cART fulfilling the below criteria are eligible for the study: Antiretroviral therapy (ART) should have been initiated at least 6 months prior to screening / Patient has to have been on the same protocol-approved ARV regimen for ≥ 8 weeks prior to screening and is expected to continue the current ARV regimen through the end of study / HIV ARVs: agents allowed in this study should be administered per the prescribing information in the package insert / Screening HIV RNA < 50 copies/mL / Screening CD4 cell count ≥ 100 cells/uL

• HIV/HCV co-infected patients not receiving cART: Screening CD4 cell count must be ≥ 500 cells/uL

Other Locations
Department of Medicine/Gastroenterology, Hospital Sultanah Bahiyah
Alor Setar
Department of Medicine/ Gastroenterology, Hospital Ampang
Department of Hepatology, Hospital Selayang
Batu Caves
Hospital Sultanah Aminah
Johor Bahru
Hospital Raja Perempuan Zainab II
Kota Bahru
Department of Medicine/Gastroenterology, University Malaya Medical Centre
Kuala Lumpur
Hospital Sultanah Nur Zahirah
Kuala Terengganu
Hospital Tengku Ampuan Afzan ,Pusat Penyelidikan Klinikal,Aras Bawah ,Bangunan Pengurusan,Jalan Tanah Putih
Department of Medicine/Infectious Disease, Hospital Sungai Buloh
Sungai Buloh
Internal Medicine, Bamrasnaradura Infectious Diseases Institute
King Chulalongkorn Memorial Hospital/HIV-NAT, Faculty of Medicine, Chulalongkorn University
Gastroenterology unit, Department of Internal Medicine, Maharaj Nakorn Chiang Mai Hospital, Faculty of Medicine, Chiang Mai University
Chiang Mai
Internal Medicine unit, Medical Department, Nakornping Hospital
Chiang Mai
Time Frame
Start Date: September 2016
Estimated Completion Date: March 2024
Target number of participants: 603
Experimental: sofosbuvir + ravidasvir
12 weeks for non-cirrhotic patients, 24 weeks for cirrhotic patients
Related Therapeutic Areas
Collaborators: National Science and Technology Development Agency, Thailand, Ministry of Health, Thailand, Ministry of Health, Malaysia
Leads: Drugs for Neglected Diseases

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