Study Results
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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COMPLETED
200 participants
OBSERVATIONAL
2008-04-30
2011-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
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
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
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Swiss HIV Cohort Study
NETWORK
Merck Sharp & Dohme LLC
INDUSTRY
University of Zurich
OTHER
Responsible Party
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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
Countries
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Related Links
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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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