An observational study in HIV Infection, sponsored by University of Zurich. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-06-06.
Sponsored by University of Zurich · Observational
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.
4,257 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 200 is close to the median of 200 across 713 observational studies indexed under HIV Infections.
Browse HIV Infections studies →University of Zurich is the lead sponsor of 1,030 studies on the registry; 130 are open to participants now.
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The Swiss HIV Cohort study is a nationwide observational cohort existing for more than 20 years and is representative of the HIV-infected population in Switzerland (approx. 50% of HIV-infected patients in Switzerland, participate in this study). All patients must sign an informed consent to participate in this study.
The study population enrolled in the current "Raltegravir in the SHCS" study, is a subgroup of patients, that has to go on Raltegravir within the Swiss HIV Cohort study.
Exclusion Criteria:
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.
Drug: 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.
Drug: Raltegravir
Raltegravir standard dosage of 400mg tablets every 12 hours together with an optimized backbone antiretroviral drug regimen
Also known as: Isentress
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
This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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University of Zurich