Rollover Protocol Continued Access to Emtricitabine/Tenofovir Disoproxil Fumarate for Subjects in United States
Status: | Completed |
---|---|
Conditions: | Hepatitis |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - 75 |
Updated: | 4/21/2016 |
Start Date: | August 2009 |
End Date: | November 2015 |
A Rollover Protocol to Provide Open-Label Emtricitabine/Tenofovir Disoproxil Fumarate Combination Product to Subjects Completing the GS-US-203-0107 Study
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.
fumarate (DF) for an additional 5 years to subjects completing study GS-US-203-0107.
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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