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

Use our guide to learn which trials are right for you!

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.


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.
We found this trial at
4
sites
?
mi
from
New York, NY
Click here to add this to my saved trials
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
San Francisco, CA
Click here to add this to my saved trials