Raltegravir in the Swiss HIV Cohort Study

NCT ID: NCT00904644

Last Updated: 2018-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-04-30

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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HIV Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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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.

Raltegravir

Intervention Type DRUG

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.

Raltegravir

Intervention Type DRUG

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

Interventions

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Raltegravir

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

Intervention Type DRUG

Other Intervention Names

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Isentress

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* drop out of the Swiss HIV Cohort study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Swiss HIV Cohort Study

NETWORK

Sponsor Role collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Huldrych F Günthard, MD

Role: PRINCIPAL_INVESTIGATOR

University of Zurich, University Hospital of Zurich, Switzerland

Locations

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University Hospital Zurich

Zurich, , Switzerland

Site Status

Countries

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Switzerland

Related Links

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http://www.shcs.ch

Describes the Swiss HIV Cohort Study

Other Identifiers

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SHCS Project No 564

Identifier Type: -

Identifier Source: org_study_id

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