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
Information source: Gilead Sciences
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Hepatitis B
Intervention: emtricitabine/tenofovir disoproxil fumarate (Drug)
Phase: Phase 2
Status: Not yet recruiting
Sponsored by: Gilead Sciences Official(s) and/or principal investigator(s):
Lewis Teperman, Principal Investigator, Affiliation: The Mary Lea Johnson Richards Organ Transplantation Center, New York University Medical Center
Overall contact:
Jane Anderson, Email: jane.anderson@gilead.com
Summary
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.
Clinical Details
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
Study design: Treatment, Open Label, Uncontrolled, Single Group Assignment
Primary outcome: No statistical analyses are planned. Listings will include subject enrollment, subject disposition and SAEs
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Jane Anderson, Email: jane.anderson@gilead.com
New York, New York, United States
Additional Information
Starting date: August 2009
Ending date: August 2015
Last updated: July 9, 2009
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