Since June 2007, raltegravir has been available in Switzerland within a named patient program
for patients who have virologic failure, triple class experience and resistance, and no other
treatment options. This proposal has been designed to evaluate efficacy and safety data among
patients who receive raltegravir within the routine clinical practice in Switzerland and who
participate in the Swiss HIV Cohort Study. This is a combined retrospective analysis of
patients who already received raltegravir and a prospective part of patients who enter the
named patient program and will be followed up in a standardized way. In the prospective part,
patients will also be able to receive raltegravir in case of intolerance to their current
medication with virologic suppression.
The analysis will primarily use descriptive statistics. In addition, we will assess the
duration of virologic response and focus on predictors of HIV RNA suppression during a
follow-up of at least 6 months. In the prospective part, we will assess trough plasma levels
of raltegravir and other antiretrovirals. In patients who will develop virologic failure,
genotypic and phenotypic resistance to raltegravir (and other antiretrovirals) will be
performed to characterize the evolution of resistance during the raltegravir-containing
regimen.