Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 1 or 4 HCV and HIV-1 Co-infection
Public ClinicalTrials.gov record NCT02073656. 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
A Phase 3, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 1 or 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Co-infection
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study will evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) administered for 12 weeks in hepatitis C virus (HCV) treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic genotype 1 or 4 HCV infection who are co-infected with HIV-1. Participants who experience confirmed post-treatment virologic failure (relapse) at or before Posttreatment Week 24 may be eligible to be enrolled in the Retreatment Substudy to receive LDV/SOF plus ribavirin (RBV) for 24 weeks.
Study identification
- NCT ID
- NCT02073656
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 335 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- 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
- Feb 2014 (Type not available)
- Primary completion
- Nov 2014 (Actual)
- Completion
- Dec 2015 (Actual)
- Last update posted
- Nov 16, 2018
2014 – 2015
United States locations
- U.S. sites
- 34
- U.S. states
- 19
- U.S. cities
- 34
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Birmingham | Alabama | 35294-2170 | — |
| Not listed | Los Angeles | California | 90027 | — |
| Not listed | Newport Beach | California | 92663 | — |
| Not listed | Palo Alto | California | 94304-5350 | — |
| Not listed | Sacramento | California | 95817 | — |
| Not listed | San Diego | California | 92103 | — |
| Not listed | San Francisco | California | 94110 | — |
| Not listed | Torrance | California | 90502 | — |
| Not listed | Denver | Colorado | 80209 | — |
| Not listed | Washington D.C. | District of Columbia | 20815 | — |
| Not listed | Bradenton | Florida | 34209 | — |
| Not listed | Miami | Florida | 33136 | — |
| Not listed | Orlando | Florida | 32803 | — |
| Not listed | Tampa | Florida | 33614 | — |
| Not listed | Atlanta | Georgia | 30312 | — |
| Not listed | Decatur | Georgia | 30033 | — |
| Not listed | Chicago | Illinois | 60612 | — |
| Not listed | Lutherville | Maryland | 21093 | — |
| Not listed | Boston | Massachusetts | 02115 | — |
| Not listed | Kansas City | Missouri | 64111 | — |
| Not listed | Santa Fe | New Mexico | 87505 | — |
| Not listed | New York | New York | 10065 | — |
| Not listed | The Bronx | New York | 10468 | — |
| Not listed | Chapel Hill | North Carolina | 27599 | — |
| Not listed | Durham | North Carolina | 27710 | — |
| Not listed | Cincinnati | Ohio | 45267-0595 | — |
| Not listed | Allentown | Pennsylvania | 18102 | — |
| Not listed | Philadelphia | Pennsylvania | 19107 | — |
| Not listed | Providence | Rhode Island | 02906 | — |
| Not listed | Dallas | Texas | 75235 | — |
| Not listed | Houston | Texas | 77004 | — |
| Not listed | Annandale | Virginia | 22003 | — |
| Not listed | Richmond | Virginia | 23298-0341 | — |
| Not listed | Seattle | Washington | 98104 | — |
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 7 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02073656, 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 Nov 16, 2018 · Synced Oct 22, 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 public registry record, listed eligibility criteria, and available contact information for NCT02073656 live on ClinicalTrials.gov.