Raltegravir in the Swiss HIV Cohort Study - Full Text View

Sponsor:	University of Zurich
Collaborators:	Swiss HIV Cohort Study Merck
Information provided by:	University of Zurich
ClinicalTrials.gov Identifier:	NCT00904644

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

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Raltegravir

U.S. FDA Resources

Further study details as provided by University of Zurich:

Primary Outcome Measures:

HIV RNA < 50 copies/ml [ Time Frame: after 6 and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Biospecimen Retention: Samples With DNA

Biospecimen 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)

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)

Groups/Cohorts	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
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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

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

Investigators

Principal Investigator:

Huldrych F Günthard, MD

University of Zurich, University Hospital of Zurich, Switzerland

More Information

Additional Information:

Describes the Swiss HIV Cohort Study This link exits the ClinicalTrials.gov site

No publications provided

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

Keywords provided by University of Zurich:

HIV
antiretroviral treatment
Swiss HIV Cohort Study

drug resistance
integrase inhibitor
Treatment

Additional relevant MeSH terms:

Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on February 08, 2010