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

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ClinicalTrials.gov Identifier: NCT00936715
Recruitment Status : Completed
First Posted : July 10, 2009
Results First Posted : June 2, 2017
Last Update Posted : June 2, 2017
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
The objective of this study is to provide open label emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) for an additional 5 years (240 weeks) to adults completing study GS-US-203-0107.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis B Drug: FTC/TDF Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : August 2009
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hepatitis B

Arm Intervention/treatment
Experimental: FTC/TDF Drug: FTC/TDF
200/300 mg tablet administered orally once daily
Other Name: Truvada®




Primary Outcome Measures :
  1. Number of Participants Who Had Access to, and Received the Intervention [ Time Frame: Up to 240 weeks ]
    This endpoint has been included to satisfy the requirements of ClinicalTrials.gov. However, there were no prespecified endpoints in this study.



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

Key Inclusion Criteria:

  • Complete all end of study visit procedures and pharmacokinetic (PK) substudy (if applicable) for the GS US 203 0107 study.
  • A negative pregnancy test is required for female individuals 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 individuals 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 individuals who are sexually active are required to use barrier contraception (condom with spermicide) during heterosexual intercourse through to study completion.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00936715


Locations
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
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Gilead Study Director Gilead Sciences

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT00936715     History of Changes
Other Study ID Numbers: GS-US-203-0109
First Posted: July 10, 2009    Key Record Dates
Results First Posted: June 2, 2017
Last Update Posted: June 2, 2017
Last Verified: May 2017

Studies a U.S. FDA-regulated Drug Product: Yes

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
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Tenofovir
Emtricitabine
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