Trials / Completed
CompletedNCT01939197
A Multipart, Open-label Study to Evaluate the Safety and Efficacy of ABT-450/r/ABT-267 With and Without ABT-333 Coadministered With and Without Ribavirin in Adult With Genotype 1 or 4 Hepatitis C Virus (HCV) Infection and Human Immunodeficiency Virus, Type 1 Coinfection
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)
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 318 (actual)
- Sponsor
- AbbVie · Industry
- Sex
- All
- Age
- 18 Years – 99 Years
- Healthy volunteers
- Not accepted
Summary
The primary objectives of this study are to assess the safety of ABT-450/r/ABT-267 with and without ABT-333 coadministered with and without ribavirin (RBV) for 12 and 24 weeks in HCV GT1- or 4-infected participants with HIV-1 coinfection and to evaluate the percentage of subjects achieving HCV ribonucleic acid (RNA) \< lower limit of quantification (LLOQ) 12 weeks following treatment.
Conditions
- Hepatitis C Virus Infection
- Human Immunodeficiency Virus Infection
- Chronic Hepatitis C
- Compensated Cirrhosis and Non-cirrhotics
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ABT-450/r/ABT-267 | tablet |
| DRUG | ABT-333 | tablet |
| DRUG | ribavirin | tablet |
Timeline
- Start date
- 2013-08-30
- Primary completion
- 2016-07-21
- Completion
- 2016-10-25
- First posted
- 2013-09-11
- Last updated
- 2021-07-12
- Results posted
- 2017-11-17
Source: ClinicalTrials.gov record NCT01939197. Inclusion in this directory is not an endorsement.