To assess the safety of 48 weeks of treatment with 10 milligrams (mg) of elvucitabine in combination with background antiretroviral therapy (ART) in participants who completed Study ACH443-014A and meet the inclusion and exclusion criteria.
This study is an open-label extension study for participants who have completed 14 days of treatment in Study ACH443-014A and meet all inclusion and exclusion criteria. Elvucitabine treatment (10 mg) will begin on Day 1 (Day 15 following completion of Study ACH443-014A) for all consenting participants in combination with background ART as determined by the Principal Investigator. Participants will have clinical and laboratory assessments every 2 weeks for the first 8 weeks and then every 4 weeks to Week 48.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
4
Elvucitabine 10 mg in combination with background ART
Clinical Trial Site
Atlanta, Georgia, United States
Clinical Trial Site
Cincinnati, Ohio, United States
Clinical Trial Site
Santo Domingo, Dominican Republic
Clinical Trial Site
Berlin, Germany
To Assess The Safety Of 48 Weeks Of 10 mg/daily (QD) Of Elvucitabine In Combination With ART
Time frame: September 2008
To Describe The Anti-viral Activity Of Elvucitabine In Combination With ART As Measured By Plasma HIV-1 Ribonucleic Acid (RNA) Over 24 Weeks
Time frame: September 2008
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Clinical Trial Site
Bonn, Germany
Clinical Trial Site
Cologne, Germany
Clinical Trial Site
Madrid, Spain