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NCT02073656 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 335
- Enrollment target
NCT02073656: Completed Phase 3 study, sponsored by Gilead Sciences.
NCT02073656 is a Phase 3 study that has completed, run by Gilead Sciences. The registered enrollment target is 335 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02073656, a Phase 3 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 335 participants
- Enrollment target
Study Summary
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.
Primary Outcome
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.
Interventions
- DRUG RBV
- DRUG LDV/SOF
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 335 participants |
| Start Date | 2014-02 |
| Est. Completion | 2015-12 |
| Phase | Phase 3 |
What the finished NCT02073656 record still lists
NCT02073656 is an interventional study that assigns participants to a tested intervention. The registered 335 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 2 interventions - of which RBV is the first listed.
NCT02073656 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02073656 about?
NCT02073656 is a clinical study titled "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". 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...
What is the current status of trial NCT02073656?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 335 participants. The study started on 2014-02. Estimated completion is 2015-12.
What interventions are being tested in trial NCT02073656?
The interventions under investigation include: RBV (DRUG), LDV/SOF (DRUG).
Who is sponsoring clinical trial NCT02073656?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02073656's enrollment target sits among peer trials
335 1061st of 2000 higher than 940 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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