Recruiting

Study Description:

In the mid-90s, the advent of combination antiretroviral therapies (cART), i.e. highly active antiretroviral therapies, markedly changed the prognosis for patients with human immunodeficiency virus infection (HIV+). The term cART is used to designate a combination therapy designed to achieve maximum suppression of the viral burden. HIV infection is now considered a chronic disease for which effective therapies are available rather than a disease with poor prognosis1,2. Celsentri (or Selzentry® - drug substance: maraviroc) was the first antiretroviral drug in the CCR5 receptor antagonist class to obtain a marketing authorization (MA) in Europe. The marketing authorization was granted by the European Medicines Agency on 18 September 2007. Maraviroc, in combination with other antiretroviral drugs, is indicated in the treatment of HIV infection with detected CCR5 tropism only in adults pretreated with antiretrovirals. On 11 June 2008, the Transparency Commission of the French High Authority for Health (HAS) formulated a favorable opinion on the inclusion of maraviroc on the list of proprietary medicinal products reimbursed for patients with social security coverage and on inclusion on the list of medicinal products accredited for use by collective institutions and miscellaneous public services. Viral tropism determination is necessary prior to maraviroc treatment since the latter is not effective for patients infected by viruses with tropisms other than R5, CXCR4 tropism or double/mixed tropism viruses. Phenotypic tropism tests and genotypic tropism tests have been recommended by the HAS since 2009. Evaluation of the public health value of maraviroc thus necessitates both data on HIV-1 tropism determination and long-term follow-up data.

Viiv Study ID:

116483


Has Results Document Available
Clinicaltrials.gov Identifier:

Not Available


EudraCT Number:

Not Available


Study Overview

Medical Conditions

Human Immunodeficiency Virus (HIV)

Product

maraviroc

Collaborators

GSK


Date

January 2012 to June 2015

Type

Observational

Phase

N/A


Gender

Both

Age

18 Year+

Accepts Healthy Volunteers

none


Study Documents


Locations

  • Central Contact :

    Not available

  • Central Contact Phone:

    877-379-3718

  • Central Contact Email:

    [email protected]


Study Design

  • Primary Purpose: Not Available
  • Allocation: Not Available
  • Study Design: Not Available
  • Study Classification: Not Available
  • Masking: Not Available
  • Masked Subject: No
  • Masked Caregiver: No
  • Masked Investigator: No
  • Masked Assessor: No
Primary Outcomes:

  • • to describe the HIV-1 patients treated with maraviroc
    Timeframe: 2008-2011

Secondary Outcomes:

  • to describe the tropism tests conducted prior to maraviroc prescription
    Timeframe: 2008-2011

Arms:
  • N/A

Interventions:

  • drug: maraviroc
Inclusion / Exclusion Criteria: Click to view inclusion/exclusion criteria:
Enrollment: 700