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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00936715
First received: July 9, 2009
Last updated: August 25, 2014
Last verified: August 2014
  Purpose

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
Drug: FTC/TDF
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 Subjects Completing the GS-US-203-0107 Study Continued Access to the Fixed Dose Combination Product Emtricitabine/Tenofovir Disoproxil Fumarate

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 ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: August 2009
Estimated Study Completion Date: November 2015
Estimated 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®

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: 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
New York, New York, United States, 10016
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: John Flaherty, PharmD Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT00936715     History of Changes
Other Study ID Numbers: GS-US-203-0109
Study First Received: July 9, 2009
Last Updated: August 25, 2014
Health Authority: United States: Food and Drug Administration

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 A
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Chronic
Digestive System Diseases
DNA Virus Infections
Enterovirus Infections
Hepadnaviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Emtricitabine
Tenofovir
Tenofovir disoproxil
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014