HIV Infection
Conditions
Keywords
HIV, antiretroviral treatment, Swiss HIV Cohort Study, drug resistance, integrase inhibitor, Treatment
Brief summary
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.
Interventions
DRUGRaltegravir
Raltegravir standard dosage of 400mg tablets every 12 hours together with an optimized backbone antiretroviral drug regimen
Sponsors
Swiss HIV Cohort Study
Merck Sharp & Dohme LLC
University of Zurich
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* all patients treated with Raltegravir within the Swiss HIV Cohort Study
Exclusion criteria
* drop out of the Swiss HIV Cohort study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HIV RNA < 50 copies/ml | after 6 and 12 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 | baseline |
| time course of CD4 lymphocytes | baseline until study end |
| durability of HIV RNA suppression | time to virological failure |
| drug levels of raltegravir and other antiretroviral drugs | during first year of Ral treatment |
| evolution of resistance in patients with virologic failure while on raltegravir | time to failure |
| severe drug-related adverse events | during study period |
Countries
Switzerland
Outcome results
None listed