Sofosbuvir-Containing Regimens Without Interferon For Treatment of Acute Hepatitis C Virus (HCV) Infection

Completed · Phase 1

Conditions studied: HIV-1 Infection, Hepatitis

In brief

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).

Key facts

Study ID

NCT02128217

Run by

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

People needed

44

Starts

2014-05-30

Expected to finish

2017-05-09

Last updated by the study team

2018-04-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

• 701 University of California, San Diego AntiViral Research Center CRS — San Diego, California, United States
• 801 University of California, San Francisco HIV/AIDS CRS — San Francisco, California, United States
• Whitman Walker Health CRS (31791) — Washington D.C., District of Columbia, United States
• 2701 Northwestern University CRS — Chicago, Illinois, United States
• Rush Univ. Med. Ctr. ACTG CRS (2702) — Chicago, Illinois, United States
• 101 Massachusetts General Hospital (MGH) CRS — Boston, Massachusetts, United States
• 7804 Weill Cornell Chelsea CRS — New York, New York, United States
• 7803 Weill Cornell Upton CRS — New York, New York, United States
• 2401 Cincinnati CRS — Cincinnati, Ohio, United States
• 6201 Penn Therapeutics CRS — Philadelphia, Pennsylvania, United States
• 31443 Trinity Health and Wellness Center CRS — Dallas, Texas, United States
• 31473 Houston AIDS Research Team (HART) CRS — Houston, Texas, United States

Full record on ClinicalTrials.gov

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