Raltegravir in the Swiss HIV Cohort Study

HIV Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00904644
• Other study ID #: SHCS Project No 564
• Status: Completed
• Start date: April 2008
• Est. completion date: December 2011

Study information

• Verified date: June 2018
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2011
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• drop out of the Swiss HIV Cohort study

Related Conditions & MeSH terms

• HIV Infection
• HIV Infections

Intervention

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

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich	Zurich

Sponsors (3)

Lead Sponsor	Collaborator
University of Zurich	Merck Sharp & Dohme Corp., Swiss HIV Cohort Study

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HIV RNA < 50 copies/ml		after 6 and 12 months
Secondary	durability of HIV RNA suppression		time to virological failure
Secondary	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		baseline
Secondary	time course of CD4 lymphocytes		baseline until study end
Secondary	severe drug-related adverse events		during study period
Secondary	drug levels of raltegravir and other antiretroviral drugs		during first year of Ral treatment
Secondary	evolution of resistance in patients with virologic failure while on raltegravir		time to failure

External Links

•   Describes the Swiss HIV Cohort Study