At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 318 enrolled
Drug / intervention
ABT-450/r/ABT-267 +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating ABT-450/r/ABT-267, ABT-333, and 1 other intervention for Hepatitis C Virus Infection and 3 related conditions. Completed, enrolled 318 participants.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C Virus Infection, Human Immunodeficiency Virus Infection, Chronic Hepatitis C, Compensated Cirrhosis and Non-cirrhotics
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartAug 2013
First PostedSep 2013
Primary CompletionJul 2016
Study CompletionOct 2016
TodayJul 2026
First PostedSep 11, 2013
Enrollment StartAug 30, 2013
Primary CompletionJul 21, 2016
Study CompletionOct 25, 2016
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 12.8 years ago
Interventions
ABT-450/r/ABT-267drug
tablet
ABT-333drug
tablet
ribavirindrug
tablet