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Completed

NCT Number: NCT00904644

Raltegravir in the Swiss HIV Cohort Study

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • drop out of the Swiss HIV Cohort study

Treatment and study plan

raltegravir

Drug

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

Other names: Isentress

Primary outcomes

  1. HIV RNA < 50 copies/ml

    Time frame: after 6 and 12 months

Secondary outcomes

  1. durability of HIV RNA suppression

    Time frame: time to virological failure

  2. 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

  3. time course of CD4 lymphocytes

    Time frame: baseline until study end

  4. severe drug-related adverse events

    Time frame: during study period

  5. drug levels of raltegravir and other antiretroviral drugs

    Time frame: during first year of Ral treatment

  6. evolution of resistance in patients with virologic failure while on raltegravir

    Time frame: time to failure

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

  • Merck Sharp & Dohme LLC
  • Swiss HIV Cohort Study

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
May 20, 2009
Registry last updated
Jun 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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