Sofosbuvir-Containing Regimens Without Interferon For Treatment of Acute Hepatitis C Virus (HCV) Infection
Public ClinicalTrials.gov record NCT02128217. 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
Sofosbuvir-Containing Regimens Without Interferon For Treatment of Acute HCV in HIV-1 Infected Individuals (SWIFT-C)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Early identification of acute HCV infection is essential to prevent chronic infections and the long-term liver disease complications that may occur. Early identification and treatment of HCV during the acute phase can result in significantly higher response rates with shorter durations of therapy. Pegylated-interferon alfa (PEG-IFN) was the typical treatment for HCV infection. Participants subcutaneously inject PEG-IFN where the average duration of treatment was approximately 20 weeks. With the advancement of direct-acting antivirals (DAAs), it was possible to see if a new DAA might be non-inferior compared to (PEG-IFN). The study was designed to see if a fixed-dose combination tablet can replace the old HCV treatments by being more effective, safer and better tolerated in HIV-infected participants with new HCV infection. The study was a Phase I, open-label, two cohort clinical trial, in which 44 acutely HCV-infected HIV-1 positive participants were enrolled. Participants in each cohort were evaluated in two steps: on treatment (Step 1) and follow-up after discontinuing study treatment (Step 2). The cohorts were enrolled sequentially. Participants in Cohort 1 were enrolled and administered oral Sofosbuvir (SOF) in combination with weight-based ribavirin (RBV). Participants in Cohort 2 were enrolled and administered an oral fixed dose combination of Ledipasvir/Sofosbuvir (LDV/SOF).
Study identification
- NCT ID
- NCT02128217
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 44 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
- May 29, 2014
- Primary completion
- Feb 27, 2017
- Completion
- May 8, 2017
- Last update posted
- Apr 26, 2018
2014 – 2017
United States locations
- U.S. sites
- 12
- U.S. states
- 8
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 701 University of California, San Diego AntiViral Research Center CRS | San Diego | California | 92103 | — |
| 801 University of California, San Francisco HIV/AIDS CRS | San Francisco | California | 94110 | — |
| Whitman Walker Health CRS (31791) | Washington D.C. | District of Columbia | 20009 | — |
| 2701 Northwestern University CRS | Chicago | Illinois | 60611 | — |
| Rush Univ. Med. Ctr. ACTG CRS (2702) | Chicago | Illinois | 60612 | — |
| 101 Massachusetts General Hospital (MGH) CRS | Boston | Massachusetts | 02114 | — |
| 7804 Weill Cornell Chelsea CRS | New York | New York | 10010 | — |
| 7803 Weill Cornell Upton CRS | New York | New York | 10065 | — |
| 2401 Cincinnati CRS | Cincinnati | Ohio | 45267-0405 | — |
| 6201 Penn Therapeutics CRS | Philadelphia | Pennsylvania | 19104 | — |
| 31443 Trinity Health and Wellness Center CRS | Dallas | Texas | 75208 | — |
| 31473 Houston AIDS Research Team (HART) CRS | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02128217, 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 Apr 26, 2018 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02128217 live on ClinicalTrials.gov.