Raltegravir in the Swiss HIV Cohort Study

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

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.

Study Overview

• Status: Completed
• Conditions: HIV Infection
• Intervention / Treatment: Drug: Raltegravir

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8091
    • University Hospital Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The Swiss HIV Cohort study is a nationwide observational cohort existing for more than 20 years and is representative of the HIV-infected population in Switzerland (approx. 50% of HIV-infected patients in Switzerland, participate in this study). All patients must sign an informed consent to participate in this study.

The study population enrolled in the current "Raltegravir in the SHCS" study, is a subgroup of patients, that has to go on Raltegravir within the Swiss HIV Cohort study.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• drop out of the Swiss HIV Cohort study

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: Raltegravir; Raltegravir standard dosage of 400mg tablets every 12 hours together with an optimized backbone antiretroviral drug regimen; Other Names: Isentress
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.	Drug: Raltegravir; Raltegravir standard dosage of 400mg tablets every 12 hours together with an optimized backbone antiretroviral drug regimen; Other Names: Isentress

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
HIV RNA < 50 copies/ml	after 6 and 12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
durability of HIV RNA suppression	time to virological failure
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
time course of CD4 lymphocytes	baseline until study end
severe drug-related adverse events	during study period
drug levels of raltegravir and other antiretroviral drugs	during first year of Ral treatment
evolution of resistance in patients with virologic failure while on raltegravir	time to failure

Collaborators and Investigators

• Sponsor: University of Zurich
• Collaborators: Merck Sharp & Dohme LLC; Swiss HIV Cohort Study
• Investigators: Principal Investigator: Huldrych F Günthard, MD, University of Zurich, University Hospital of Zurich, Switzerland

Publications and helpful links

Helpful Links

• Describes the Swiss HIV Cohort Study

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: May 18, 2009
• First Submitted That Met QC Criteria: May 19, 2009
• First Posted (Estimate): May 20, 2009

Study Record Updates

• Last Update Posted (Actual): June 6, 2018
• Last Update Submitted That Met QC Criteria: June 4, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Treatment; HIV; antiretroviral treatment; drug resistance; integrase inhibitor; Swiss HIV Cohort Study
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; HIV Integrase Inhibitors; Integrase Inhibitors; Raltegravir Potassium
• Other Study ID Numbers: SHCS Project No 564