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NCT02480387 Clinical Trial

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

Treatment of Hepatitis C Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02480387
Other study ID # IN-US-337-1821
Secondary ID
Status Completed
Phase Phase 2
First received June 19, 2015
Last updated July 19, 2016
Start date May 2015
Est. completion date January 2016

Study information
Verified date February 2016
Source Peter J. Ruane, M.D., Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date January 2016
Est. primary completion date November 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Ledipasvir/Sofosbuvir FDC

Locations
Country Name City State
United States Peter J. Ruane, MD, Inc. Los Angeles California

Sponsors (1)
Lead Sponsor Collaborator
Peter J. Ruane, M.D., Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary SVR12 Sustained Virologic Response 12 Weeks Post-Treatment No