Raltegravir in the Swiss HIV Cohort Study
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
|
HIV Infection |
Drug: Raltegravir |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort |
| Official Title: | Raltegravir Use in the Swiss HIV Cohort Study (SHCS) - Evaluation of Efficacy, Safety, Plasma Levels and Evolution of Resistance |
- HIV RNA < 50 copies/ml [ Time Frame: after 6 and 12 months ] [ Designated as safety issue: No ]
- durability of HIV RNA suppression [ Time Frame: time to virological failure ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- time course of CD4 lymphocytes [ Time Frame: baseline until study end ] [ Designated as safety issue: No ]
- severe drug-related adverse events [ Time Frame: during study period ] [ Designated as safety issue: No ]
- drug levels of raltegravir and other antiretroviral drugs [ Time Frame: during first year of Ral treatment ] [ Designated as safety issue: No ]
- evolution of resistance in patients with virologic failure while on raltegravir [ Time Frame: time to failure ] [ Designated as safety issue: No ]
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)
| Estimated Enrollment: | 200 |
| Study Start Date: | April 2008 |
| Estimated Study Completion Date: | April 2012 |
| Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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 Name: 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 Name: Isentress
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
Inclusion Criteria:
- all patients treated with Raltegravir within the Swiss HIV Cohort Study
Exclusion Criteria:
- drop out of the Swiss HIV Cohort study
Contacts and Locations| Contact: Huldrych F Günthard, MD | +41 44 255 34 50 | huldrych.guenthard@usz.ch |
| Switzerland | |
| University Hospital Zurich | Recruiting |
| Zurich, Switzerland, 8091 | |
| Contact: Huldrych F Günthard, MD +4144 255 34 50 huldrych.guenthard@usz.ch | |
| Principal Investigator: Huldrych F Günthard, MD | |
| Principal Investigator: | Huldrych F Günthard, MD | University of Zurich, University Hospital of Zurich, Switzerland |
More Information
Additional Information:
No publications provided
| Responsible Party: | Prof. Huldrych Günthard, MD, University of Zurich |
| ClinicalTrials.gov Identifier: | NCT00904644 History of Changes |
| Other Study ID Numbers: | SHCS Project No 564 |
| Study First Received: | May 18, 2009 |
| Last Updated: | May 19, 2009 |
| Health Authority: | Switzerland: Ethikkommission |
Keywords provided by University of Zurich:
|
HIV antiretroviral treatment Swiss HIV Cohort Study |
drug resistance integrase inhibitor Treatment |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases |
Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Integrase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013