Raltegravir in the Swiss HIV Cohort Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by University of Zurich.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Swiss HIV Cohort Study
Merck Sharp & Dohme Corp.
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT00904644
First received: May 18, 2009
Last updated: May 19, 2009
Last verified: May 2009

May 18, 2009
May 19, 2009
April 2008
April 2010   (final data collection date for primary outcome measure)
HIV RNA < 50 copies/ml [ Time Frame: after 6 and 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00904644 on ClinicalTrials.gov Archive Site
  • durability of HIV RNA suppression [ Time Frame: time to virological failure ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • time course of CD4 lymphocytes [ Time Frame: baseline until study end ] [ Designated as safety issue: No ]
  • severe drug-related adverse events [ Time Frame: during study period ] [ Designated as safety issue: No ]
  • drug levels of raltegravir and other antiretroviral drugs [ Time Frame: during first year of Ral treatment ] [ Designated as safety issue: No ]
  • evolution of resistance in patients with virologic failure while on raltegravir [ Time Frame: time to failure ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Raltegravir in the Swiss HIV Cohort Study
Raltegravir Use in the Swiss HIV Cohort Study (SHCS) - Evaluation of Efficacy, Safety, Plasma Levels and Evolution of Resistance

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.

Not Provided
Observational
Observational Model: Cohort
Not Provided
Retention:   Samples With DNA
Description:

Within the framework of the Swiss HIV Cohort Study samples are taken of all patients regularly every 6 months. Plasma and frozen cells (www.shcs.ch)

Non-Probability Sample

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.

HIV Infection
Drug: Raltegravir
Raltegravir standard dosage of 400mg tablets every 12 hours together with an optimized backbone antiretroviral drug regimen
Other Name: Isentress
  • Salvage group
    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.
    Intervention: Drug: Raltegravir
  • Switch group
    In this group, patients are enrolled which have to switch to Raltegravir due to drug toxicity or adverse events caused by other antiretroviral drugs.
    Intervention: Drug: Raltegravir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
April 2012
April 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • drop out of the Swiss HIV Cohort study
Both
18 Years and older
No
Contact: Huldrych F Günthard, MD +41 44 255 34 50 huldrych.guenthard@usz.ch
Switzerland
 
NCT00904644
SHCS Project No 564
No
Prof. Huldrych Günthard, MD, University of Zurich
University of Zurich
  • Swiss HIV Cohort Study
  • Merck Sharp & Dohme Corp.
Principal Investigator: Huldrych F Günthard, MD University of Zurich, University Hospital of Zurich, Switzerland
University of Zurich
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP