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.
Study Type
OBSERVATIONAL
Enrollment
200
Raltegravir standard dosage of 400mg tablets every 12 hours together with an optimized backbone antiretroviral drug regimen
University Hospital Zurich
Zurich, Switzerland
HIV RNA < 50 copies/ml
Time frame: after 6 and 12 months
durability of HIV RNA suppression
Time frame: time to virological failure
predictors of HIV RNA suppression (viral load and CD4 at baseline, resistance at baseline for those with detectable HIV RNA, number of active drugs within the salvage regimen
Time frame: baseline
time course of CD4 lymphocytes
Time frame: baseline until study end
severe drug-related adverse events
Time frame: during study period
drug levels of raltegravir and other antiretroviral drugs
Time frame: during first year of Ral treatment
evolution of resistance in patients with virologic failure while on raltegravir
Time frame: time to failure
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