A Two Part, Open-label Study to Evaluate the Safety and Effectiveness of ABT-450/r/ABT-267 or ABT-450/r/ABT-267 and ABT-333 Given With or Without a Drug Called Ribavirin in People With Both Hepatitis C Virus Genotype 1 or 4 Infection and Human Immunodeficiency Virus, Type 1 Infection



Status:Completed
Conditions:Infectious Disease, HIV / AIDS, HIV / AIDS, HIV / AIDS, Gastrointestinal, Hepatitis, Hepatitis, Hepatitis
Therapuetic Areas:Gastroenterology, Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 99
Updated:10/18/2017
Start Date:August 2013
End Date:October 2016

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A Multipart, Open-label Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir With and Without Dasabuvir Coadministered With and Without Ribavirin in Adults With Genotype 1 or 4 Chronic Hepatitis C Virus Infection and Human Immunodeficiency Virus, Type 1 Coinfection (TURQUOISE-I)

The purpose of this study is to assess the safety and efficacy of
ombitasvir/paritaprevir/ritonavir with and without dasabuvir coadministered with and without
ribavirin for 12 and 24 weeks in adults with genotype 1 or 4 Chronic Hepatitis C Virus
Infection with Human Immunodeficiency Virus, Type 1 coinfection.


Inclusion Criteria:

- Chronic HCV infection at Screening defined as: Positive anti-HCV Ab at Screening and
HCV RNA > 1,000 IU/mL at Screening.

- Plasma HIV-1 RNA <40 copies/mL during Screening using Abbott RealTime HIV-1 assay.

- On a stable qualifying human immunodeficiency virus, type 1 (HIV-1) antiretroviral
therapy regimen.

Exclusion Criteria:

- Positive test result at screening for Hepatitis B surface antigen.

- Evidence of HCV genotype other than genotype 1 or genotype 4 during screening.

- Receipt of any other investigational or commercially available anti-HCV agents (for
example, telaprevir, boceprevir, simeprevir, daclatasvir and ledipasvir) with the
exception of interferon (including pegylated-interferon alfa-2a or alfa-2b),
sofosbuvir and ribavirin.

- Consideration by the investigator, for any reason, that the subject is an unsuitable
candidate to receive ABT-450, ABT-267, ABT-333, ritonavir or ribavirin.

- Chronic human immunodeficiency virus, type 2 (HIV-2) infection.
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Adelaide,
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Washington,
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West Palm Beach, FL
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