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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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00936715
First received: July 9, 2009
Last updated: January 5, 2011
Last verified: January 2011
History of Changes
  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: emtricitabine/tenofovir disoproxil fumarate
 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:

U.S. FDA Resources

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 ]

Estimated Enrollment: 40
Study Start Date: August 2009
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: emtricitabine/tenofovir disoproxil fumarate
    fixed dose combination tablet emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg
    Other Names:
    • Truvada
    • FTC/TDF
  Eligibility

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
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, 94143
San Francisco, California, United States, 94115
United States, New York
New York, New York, United States
New York, New York, United States, 10016
Sponsors and Collaborators
Gilead Sciences
Investigators
Principal Investigator: Lewis Teperman The Mary Lea Johnson Richards Organ Transplantation Center, New York University Medical Center
  More Information

No publications provided

Responsible Party: Stephen Rossi, PharmD/ Sr. Director, Clinical Research, 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: January 5, 2011
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, Chronic
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
 Tenofovir
Tenofovir disoproxil
Emtricitabine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on May 22, 2013