Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 8 Weeks in Subjects With Chronic Genotype 1 HCV and HIV-1 Co-infection
| Status: | Completed |
|---|---|
| Conditions: | HIV / AIDS, HIV / AIDS, Hepatitis, Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/21/2016 |
| Start Date: | May 2015 |
| End Date: | January 2016 |
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
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
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
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)
We found this trial at
1
site
Click here to add this to my saved trials
