Raltegravir in the Swiss HIV Cohort Study

University of Zurich (UZH)

Status: Completed

Conditions: HIV Infection

Treatments: Drug: Raltegravir

Study type: Observational

Funder types: Other; NETWORK; Industry

Identifiers

NCT00904644

SHCS Project No 564

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• drop out of the Swiss HIV Cohort study

Trial design

200 participants in 2 patient groups

Salvage group

Description:

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.

Treatment:

Drug: Raltegravir

Switch group

Description:

In this group, patients are enrolled which have to switch to Raltegravir due to drug toxicity or adverse events caused by other antiretroviral drugs.

Treatment:

Drug: Raltegravir