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Raltegravir in the Swiss HIV Cohort Study

NCT00904644 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2018-06-06

No results posted yet for this study

Summary

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.

Conditions

  • HIV Infection

Interventions

DRUG

Raltegravir

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

Sponsors & Collaborators

  • Swiss HIV Cohort Study

    collaborator NETWORK

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • University of Zurich

    lead OTHER

Principal Investigators

  • Huldrych F Günthard, MD · University of Zurich, University Hospital of Zurich, Switzerland

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2010-04-30
Completion
2011-12-31

Countries

  • Switzerland

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00904644 on ClinicalTrials.gov