Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Coinfection
Status: | Completed |
---|---|
Conditions: | Infectious Disease, HIV / AIDS, HIV / AIDS, HIV / AIDS, Hepatitis, Hepatitis, Hepatitis |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 11/18/2018 |
Start Date: | July 1, 2015 |
End Date: | June 22, 2016 |
A Phase 3, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks in Subjects With Chronic Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Coinfection
The primary objectives of this study are to evaluate the efficacy, safety and tolerability of
treatment with sofosbuvir/velpatasvir (SOF/VEL) for 12 weeks in participants with chronic HCV
infection who were coinfected with HIV-1.
treatment with sofosbuvir/velpatasvir (SOF/VEL) for 12 weeks in participants with chronic HCV
infection who were coinfected with HIV-1.
Key Inclusion Criteria:
- HCV RNA ≥ 10^4 IU/mL at screening
- HCV genotype 1, 2, 3, 4, 5, 6
- Cirrhosis determination, a fibroscan or liver biopsy may be required
- HIV-1 infection
- Use of protocol specified method(s) of contraception
- Screening laboratory values within defined thresholds
Key Exclusion Criteria:
- Clinically-significant illness (other than HCV or HIV) or any other major medical
disorder that may interfere with individual's treatment, assessment or compliance with
the protocol
- Current or prior history of clinical hepatic decompensation, hepatocellular carcinoma
(HCC) or other malignancy (with the exception of certain resolved skin cancers)
- Screening ECG with clinically significant abnormalities
- Pregnant or nursing female or male with pregnant female partner
- Infection with hepatitis B virus (HBV)
- Use of any prohibited concomitant medications as described in the protocol
- Chronic use of systemically administered immunosuppressive agents
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
We found this trial at
15
sites
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