Raltegravir in the Swiss HIV Cohort Study

NCT00904644 | Completed

• 1 other identifier: SHCS Project No 564
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

HIV; antiretroviral treatment; Swiss HIV Cohort Study; drug resistance; integrase inhibitor; Treatment

Outcome Measures

Primary Outcomes (1)

• HIV RNA < 50 copies/ml

  after 6 and 12 months

Secondary Outcomes (6)

• 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

Study Arms (2)

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

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

Interventions

Raltegravir DRUG

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

Also known as: Isentress

Salvage group; Switch group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• drop out of the Swiss HIV Cohort study

Sponsors & Collaborators

• University of Zurich: lead
• Swiss HIV Cohort Study: collaborator
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

University Hospital Zurich

Zurich, 8091, Switzerland

Location

Related Links

• Describes the Swiss HIV Cohort Study

Biospecimen

Retention: SAMPLES WITH DNA

Within the framework of the Swiss HIV Cohort Study samples are taken of all patients regularly every 6 months. Plasma and frozen cells (www.shcs.ch)

MeSH Terms

Conditions

HIV Infections

Interventions

Raltegravir Potassium

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Huldrych F Günthard, MD

  University of Zurich, University Hospital of Zurich, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2009
• First Posted: May 20, 2009
• Study Start: April 1, 2008
• Primary Completion: April 1, 2010
• Study Completion: December 1, 2011
• Last Updated: June 6, 2018

Record last verified: 2018-06

Locations

CH (1)