Raltegravir in the Swiss HIV Cohort Study
- Registration Number
- NCT00904644
- Lead Sponsor
- University of Zurich
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- all patients treated with Raltegravir within the Swiss HIV Cohort Study
- drop out of the Swiss HIV Cohort study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Switch group Raltegravir In this group, patients are enrolled which have to switch to Raltegravir due to drug toxicity or adverse events caused by other antiretroviral drugs. Salvage group Raltegravir In this group patients are enrolled that have failed previous antiretroviral drug regimens and qualify for Raltegravir treatment according to the approved indication of this drug in Switzerland.
- Primary Outcome Measures
Name Time Method HIV RNA < 50 copies/ml after 6 and 12 months
- Secondary Outcome Measures
Name Time Method durability of HIV RNA suppression 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 baseline drug levels of raltegravir and other antiretroviral drugs during first year of Ral treatment time course of CD4 lymphocytes baseline until study end severe drug-related adverse events during study period evolution of resistance in patients with virologic failure while on raltegravir time to failure
Trial Locations
- Locations (1)
University Hospital Zurich
🇨🇭Zurich, Switzerland