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NIAID HIV and Emerging Infectious Diseases Program

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SYNERGY Study

Study Name

A Pilot Study to Evaluate the Safety and Efficacy of Multiple Anti-HCV Combination Therapy in Chronically Infected Hepatitis C Patients

Study Number

13-I-0066

Goal of Study

This study is the first study done in the US to see if 12 weeks of treatment with one of these two-drug combinations, taken as pills, is safe and effective for the treatment of HCV. We have already enrolled 20 people who had never done HCV treatment before; we are now enrolling 20 people who have been treated for HCV with “interferons,” but did not achieve a good enough response in the first 12 weeks. This study will help us learn who may benefit from taking only pills, like the ones in this study, to cure hepatitis C. After starting the study medications, if you have to stop this study for certain reasons, you will be offered the FDA approved standard treatment for hepatitis C (which will contain interferon, ribavirin, and another drug that blocks hepatitis C, called an HCV protease inhibitor) under another clinical study.

Study Regimen

GS-7977, GS-5885 and GS-9669 are new medications that are being developed for the treatment of hepatitis C infection. They are still being researched and are not approved by the Food and Drug Administration (FDA). The purpose of this study is to determine whether GS-7977 in combination with EITHER GS-5885, or with GS-9669, can be safe and effective for treating hepatitis C infection. The manufacturer, Gilead Sciences, Inc., will provide the study drugs. If you are eligible for the study, you will be enrolled in ONE of the two study groups where you will follow one of the following two possible medication plans for 12 weeks: GS-7977 and GS-5885, OR GS-7977 and GS-9669. Study medications and volunteer compensation will be provided.

Eligibility Criteria

  • Age 18 years or older with documented HCV infection
  • Willing to give informed consent and ability to comply with study requirements
  • You were previously treated with interferon but did not show a large decrease of virus in the first 12 weeks of treatment
  • Are HIV-negative
  • Have a Body Mass Index (BMI) of at least 18
  • Willing to either practice sexual abstinence or use a barrier method of contraception throughout the study and for 30 days from last study medication dose
  • Have HCV Genotype 1 or Genotype 4
  • Have a HCV viral load >2000
  • Have adequate veins for access to blood draws
  • Have a Primary Care Physician
  • Have no other significant illnesses that may interfere with study treatment
  • Have no current substance abuse that is likely to interfere with study compliance
  • Are not pregnant or breast-feeding​

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Last Updated August 05, 2013

Last Reviewed June 07, 2013