Study in Healthy Volunteers of the Safety and Metabolism of Different Doses of the Anti-HIV Drug TMC278LA.
Status:
Completed
Trial end date:
2012-06-01
Target enrollment:
Participant gender:
Summary
TMC278 (also called rilpivirine) is a new drug being developed to treat HIV. Usually TMC278
is taken as a tablet, by mouth, once a day, but a 'long acting' formulation has been
developed so the drug stays in the bloodstream for a longer time - this allows the drug to be
given by injection and less often. It is hoped that this injectable version of the drug may
be used to help prevent HIV transmission in the future by giving it to people who are at risk
of HIV. This is similar to the way travellers to areas with malaria may take antibiotics to
prevent infection. The investigators aim to investigate the feasibility of using TMC278 as a
preventative medication by performing this study.
The purpose of this study is to investigate the levels of drug which can be measured in the
blood, as well as the tissues and fluids of the rectum (the lowest part of the bowels just
before the opening of the anus) as well as the safety of the drug and how well tolerated it
is when given as a single dose. In this study, the investigators will not be investigating
whether the drug prevents HIV so the investigators will recruit people who are HIV negative,
and whose lifestyle does not put them at risk of becoming infected before or during the
study.
If the study shows the drug is well tolerated and produces appropriate levels of the drug (in
the bloodstream and the rectal compartment) to suggest that it could be effective, it will
help design future studies looking at preventing HIV.