Phase III Trial of BI 201335 (Faldaprevir) in Treatment Naive (TN) and Relapser Hepatitis C Virus (HCV)-Human Immunodeficiency Virus (HIV) Coinfected Patients (STARTverso 4)
Public ClinicalTrials.gov record NCT01399619. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Safety and Efficacy of 120mg and 240mg BI 201335 Once Daily in Combination With Pegylated Interferon Alpha and Ribavirin for Treatment of Chronic Hepatitis C (HCV) Genotype 1 Infection in HIV/HCV Co-infected Patients. A Multinational, Randomised, Parallel Group, Open-label Trial.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
the aim of this trial is to evaluate the efficacy and the safety of BI 201335 given for 12 or 24 weeks in combination with PegIFN/RBV given for 24-48 weeks, according to re-randomisation of Early Treatment Success (ETS) patients at 24 weeks to stop PegIFN/RBV or continue PegIFN/RBV until week 48. If no ETS, then PegIFN/RB for 48 weeks, in HCV treatment-naive or relapsers patients coinfected with HIV
Study identification
- NCT ID
- NCT01399619
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 310 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 70 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 31, 2011
- Primary completion
- Aug 31, 2013
- Completion
- May 31, 2014
- Last update posted
- Aug 28, 2016
2011 – 2014
United States locations
- U.S. sites
- 22
- U.S. states
- 12
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 1220.19.0045 Boehringer Ingelheim Investigational Site | Birmingham | Alabama | — | — |
| 1220.19.0007 Boehringer Ingelheim Investigational Site | Palm Springs | California | — | — |
| 1220.19.0031 Boehringer Ingelheim Investigational Site | San Francisco | California | — | — |
| 1220.19.0005 Boehringer Ingelheim Investigational Site | Washington D.C. | District of Columbia | — | — |
| 1220.19.0086 Boehringer Ingelheim Investigational Site | Fort Lauderdale | Florida | — | — |
| 1220.19.0044 Boehringer Ingelheim Investigational Site | Orlando | Florida | — | — |
| 1220.19.0004 Boehringer Ingelheim Investigational Site | Vero Beach | Florida | — | — |
| 1220.19.0079 Boehringer Ingelheim Investigational Site | Lutherville | Maryland | — | — |
| 1220.19.0027 Boehringer Ingelheim Investigational Site | Framingham | Massachusetts | — | — |
| 1220.19.0008 Boehringer Ingelheim Investigational Site | Camden | New Jersey | — | — |
| 1220.19.0009 Boehringer Ingelheim Investigational Site | Hillsborough | New Jersey | — | — |
| 1220.19.0011 Boehringer Ingelheim Investigational Site | Albany | New York | — | — |
| 1220.19.0006 Boehringer Ingelheim Investigational Site | New York | New York | — | — |
| 1220.19.0014 Boehringer Ingelheim Investigational Site | New York | New York | — | — |
| 1220.19.0084 Boehringer Ingelheim Investigational Site | New York | New York | — | — |
| 1220.19.0021 Boehringer Ingelheim Investigational Site | Winston-Salem | North Carolina | — | — |
| 1220.19.0013 Boehringer Ingelheim Investigational Site | Philadelphia | Pennsylvania | — | — |
| 1220.19.0029 Boehringer Ingelheim Investigational Site | Austin | Texas | — | — |
| 1220.19.0012 Boehringer Ingelheim Investigational Site | Dallas | Texas | — | — |
| 1220.19.0060 Boehringer Ingelheim Investigational Site | Fort Worth | Texas | — | — |
| 1220.19.0016 Boehringer Ingelheim Investigational Site | San Antonio | Texas | — | — |
| 1220.19.0026 Boehringer Ingelheim Investigational Site | Richmond | Virginia | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 49 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01399619, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 28, 2016 · Synced Sep 2, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01399619 live on ClinicalTrials.gov.