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Clinical Trials

MainTitle

Raltegravir in the Swiss HIV Cohort Study

The recruitment status of this study is unknown.

Verified May 2009

Sponsor
University of Zurich

Collaborator
Swiss HIV Cohort Study
Merck Sharp & Dohme Corp.

Information provided by (Responsible Party)
University of Zurich
ClinicalTrials.gov Identifier
NCT00904644

First received: May 18, 2009
Last updated: May 19, 2009
Last Verified: May 2009
History of Changes
Purpose

Purpose

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.

Condition Intervention
HIV Infection

Drug : Raltegravir

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Raltegravir Use in the Swiss HIV Cohort Study (SHCS) - Evaluation of Efficacy, Safety, Plasma Levels and Evolution of Resistance

Further study details as provided by University of Zurich:

Primary Outcome Measures

  • HIV RNA < 50 copies/ml [ Time Frame: after 6 and 12 months ]
Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention: Samples With DNA
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)

Estimated Enrollment: 200
Study Start Date: April 2008
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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.
Drug: Raltegravir

Raltegravir standard dosage of 400mg tablets every 12 hours together with an optimized backbone antiretroviral drug regimen

Other Name: Isentress
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.
Drug: Raltegravir

Raltegravir standard dosage of 400mg tablets every 12 hours together with an optimized backbone antiretroviral drug regimen

Other Name: Isentress
Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  
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.

Criteria

Inclusion Criteria:

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


Exclusion Criteria:
  • drop out of the Swiss HIV Cohort study

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00904644

Contacts

Contact:   Huldrych F Günthard, MD +41 44 255 34 50 huldrych.guenthard@usz.ch

Locations

Switzerland
University Hospital Zurich Recruiting
Zurich, Switzerland, 8091
Contact: Huldrych F Günthard, MD    +4144 255 34 50    huldrych.guenthard@usz.ch
Principal Investigator: Huldrych F Günthard, MD

Sponsors and Collaborators

University of Zurich
Swiss HIV Cohort Study
Merck Sharp & Dohme Corp.

Investigators

Principal Investigator: Huldrych F Günthard, MD University of Zurich, University Hospital of Zurich, Switzerland
More Information

More Information

Additional Information:

Describes the Swiss HIV Cohort Study

Responsible Party: Prof. Huldrych Günthard, MD, University of Zurich  
ClinicalTrials.gov Identifier: NCT00904644   History of Changes  
Other Study ID Numbers: SHCS Project No 564  
Study First Received: May 18, 2009  
Last Updated: May 19, 2009  

Keywords provided by University of Zurich:

HIV
antiretroviral treatment
Swiss HIV Cohort Study
drug resistance
integrase inhibitor
Treatment

Additional relevant MeSH terms:
HIV Infections
Raltegravir Potassium

ClinicalTrials.gov processed this data on October 17, 2017
This information is provided by ClinicalTrials.gov.