Clinical trial NCT00904644: Raltegravir in the Swiss HIV Cohort Study
Official title: Raltegravir Use in the Swiss HIV Cohort Study (SHCS) - Evaluation of Efficacy, Safety, Plasma Levels and Evolution of Resistance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infection
Keywords: HIV
antiretroviral treatment
Swiss HIV Cohort Study
drug resistance
integrase inhibitor
Treatment
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Swiss HIV Cohort Study
name: Merck Sharp & Dohme LLC
First posted: 2009-05-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: Inclusion Criteria:

* all patients treated with Raltegravir within the Swiss HIV Cohort Study

Exclusion Criteria:

* drop out of the Swiss HIV Cohort study

Primary outcomes:
measure: HIV RNA < 50 copies/ml
timeFrame: after 6 and 12 months
Secondary outcomes:
measure: durability of HIV RNA suppression
timeFrame: time to virological failure
measure: 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
timeFrame: baseline
measure: time course of CD4 lymphocytes
timeFrame: baseline until study end
measure: severe drug-related adverse events
timeFrame: during study period
measure: drug levels of raltegravir and other antiretroviral drugs
timeFrame: during first year of Ral treatment
measure: evolution of resistance in patients with virologic failure while on raltegravir
timeFrame: time to failure
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: University of Zurich, University Hospital of Zurich, Switzerland
name: Huldrych F Günthard, MD
role: PRINCIPAL_INVESTIGATOR
References: