Raltegravir Use as Nonoccupational Postexposure Prophylaxis (NPEP) in Men Who Have Sex With Men
Status:
Completed
Trial end date:
2012-07-01
Target enrollment:
Participant gender:
Summary
The use of anti-HIV drugs following a potential sexual or injecting drug use exposure to HIV
in order to try and prevent an exposure from becoming an infection is common. This is called
nonoccupational postexposure prophylaxis (NPEP). The likelihood of NPEP succeeding is related
to intrinsic qualities of the drugs used which includes at which point in the life cycle of
the HIV virus the drugs work, how strong the drugs are against HIV, and how well tolerated
the drugs are i.e. what side effects they produce. Many people skip doses during their
treatment or abandon their treatment because of side effects. The anti-HIV drug raltegravir
works early in the life cycle of the virus i.e. before it integrates with human DNA, is
potent against HIV and causes few side effects. These qualities make it an obvious choice for
use as a NPEP treatment. In this study 100 HIV negative men will receive raltegravir along
with another HIV drug called truvada (commonly used in NPEP) for 28 days after a possible
sexual exposure to HIV. They will be monitored closely for adverse events, side effects and
for their ability to take the medicine each day for the whole 28 days. The hypothesis in this
study states that raltegravir use in NPEP will be safe, well tolerated and result in a high
treatment completion rate.