Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Rollover Protocol Continued Access to Emtricitabine/Tenofovir Disoproxil Fumarate for Subjects in United States

This study has been completed.
Information provided by (Responsible Party):
Gilead Sciences Identifier:
First received: July 9, 2009
Last updated: December 11, 2015
Last verified: December 2015
The objective of this study is to provide open label emtricitabine/tenofovir disoproxil fumarate (DF) for an additional 5 years to subjects completing study GS-US-203-0107.

Condition Intervention Phase
Chronic Hepatitis B
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Rollover Protocol to Provide Open-Label Emtricitabine/Tenofovir Disoproxil Fumarate Combination Product to Subjects Completing the GS-US-203-0107 Study

Resource links provided by NLM:

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • No statistical analyses are planned. Listings will include subject enrollment, subject disposition and SAEs [ Time Frame: 5 years ]

Enrollment: 24
Study Start Date: August 2009
Study Completion Date: November 2015
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FTC/TDF Drug: FTC/TDF
Emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg fixed-dose combination (FDC) tablet administered orally once daily
Other Name: Truvada®


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Complete all end of study visit procedures and PK substudy (if applicable) for the GS US 203 0107 study.
  • A negative pregnancy test is required for female subjects at the end of study visit for GS US 203 0107 (unless surgically sterile or greater than two years post-menopausal).
  • All sexually active female subjects who are not post menopausal, or surgically sterile and are of childbearing potential must agree to use a highly effective method of contraception during heterosexual intercourse throughout the study.
  • Male subjects who are sexually active are required to use barrier contraception (condom with spermicide) during heterosexual intercourse through to study completion.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00936715

United States, California
Los Angeles, California, United States, 90048
San Francisco, California, United States, 94115
United States, Florida
Miami, Florida, United States, 33136
United States, New York
New York, New York, United States, 10016
New York, New York, United States
Sponsors and Collaborators
Gilead Sciences
Study Director: John Flaherty, PharmD Gilead Sciences
  More Information

Responsible Party: Gilead Sciences Identifier: NCT00936715     History of Changes
Other Study ID Numbers: GS-US-203-0109
Study First Received: July 9, 2009
Last Updated: December 11, 2015

Keywords provided by Gilead Sciences:
prevention of chronic hepatitis B recurrence
post orthotopic liver transplant
Prevention of chronic hepatitis B recurrence in patients who have undergone orthotopic liver transplant

Additional relevant MeSH terms:
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents processed this record on May 23, 2017