Study Comparing Racivir and Lamivudine in Treatment-Experienced HIV Subjects
Status:
Completed
Trial end date:
2006-03-01
Target enrollment:
Participant gender:
Summary
Racivir ® (RCV) is an experimental drug which means it is not approved for use by the United
States Food and Drug Administration (FDA), but it can be used in research studies like this
one. RCV (Racivir®) is part of a class of drugs known as "Nucleoside Reverse Transcriptase
Inhibitors" (NRTIs), which are intended to block a further increase in the amount of HIV
virus in the body. Laboratory research suggests that RCV (Racivir®) may be effective in
patients who have developed resistance to other NRTIs, particularly 3TC (lamivudine,
Epivir®). However, a study of RCV (Racivir®) has not been done with patients who have
previously been treated with other HAART (Highly Active Antiretroviral Therapy -- taking
multiple HIV drugs at once) medications including 3TC (lamivudine, Epivir®).
The purpose of this study is to evaluate the safety and effectiveness of RCV (Racivir®) when
used together with other HIV drugs in people who have previously been treated with 3TC
(lamivudine, Epivir®) and are failing with their current HAART treatments. This study will
include a total of 60 HIV infected, HAART-experienced subjects currently receiving 3TC
(lamivudine, Epivir®) as part of their HAART therapy. The study will take place at
approximately 11 study sites in the US and Latin America.