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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 - NCT00936715-(Clinical Trial 301339)



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City:  New York
State:  
NY
Zip Code:
Conditions: Chronic Hepatitis B
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.
Study summary:
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.
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Data Source: ClinicalTrials.gov
Date Processed: December 30, 2009
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