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OpenTrials
Completed

NCT Number: NCT02480387

Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 8 Weeks in Subjects With Chronic Genotype 1 HCV and HIV-1 Co-infection

Target Population: Hepatitis C Treatment Naïve, non-cirrhotic, Chronic genotype 1 hepatitis C virus (HCV) infected adults that are co-infected with human immunodeficiency virus (HIV)-1and have HCV RNA < 6 x106 IU/mL

Duration of Subjects will be treated for 8 weeks and followed for 24 weeks post- Treatment: treatment

Completed

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Key information

Conditions

Treatment of Hepatitis C

Age range

18 year and older

Study type

Interventional

Phase

Phase 2

Primary location

Peter J. Ruane, MD, Inc.

Los Angeles, California, 90036, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Chronic HCV GT1, treatment-naïve, non-cirrhotic adult subjects.
  • HCV RNA levels more than 10,000 IU/mL and less than 6,000,000 IU/mL at Screening

Exclusion criteria

  • Gastrointestinal disorder or post-operative condition that could interfere with the absorption of the study drug.
  • Solid organ transplantation.
  • Significant cardiac disease or other significant co-morbidities that could interfere with study treatment.
  • Malignancy within the 3 years prior to screening, with the exception of specific cancers that have been cured by surgical resection (basal cell skin cancer, etc.). Subjects under evaluation for possible malignancy are not eligible.
  • Infection with hepatitis B virus (HBV)

Treatment and study plan

Ledipasvir/Sofosbuvir FDC

Drug

Other names: Harvoni

Primary outcomes

  1. SVR12

    Time frame: Sustained Virologic Response 12 Weeks Post-Treatment

Sponsors and collaborators

Lead sponsor

Peter J. Ruane, M.D., Inc.

Other

Registry information

Official study title

A Phase 2, Single-Center, Open-Label Pilot Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination for 8 Weeks in Subjects With Chronic Genotype 1 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Coinfection

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Jun 24, 2015
Registry last updated
Jul 20, 2016

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

View the official ClinicalTrials.gov record (opens in a new tab)

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.