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Management of HIV-1 Patients Treated With Antiretroviral Combination Therapy Including Raltegravir (MK0518-138) (RACING)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01048671
First received: January 12, 2010
Last updated: January 24, 2013
Last verified: January 2013
History of Changes
  Purpose

To evaluate the management of HIV-1 patients treated with antiretroviral combination therapy including the integrase inhibitor raltegravir, all across the country of France.


Condition Intervention
HIV Infections
 Drug: raltegravir

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Collection of Data on the Management of HIV-1 Patients Treated With Antiretroviral Combination Therapy Including the Integrase Inhibitor Raltegravir

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • To describe, in a real-life situation, the demographic profile and immunological and virological outcome of HIV-1 infected patients during the 24 month observation period after initiation of raltegravir therapy [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical and biological safety of raltegravir, measure by number of adverse events exhibited or reported by the patients [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]

Enrollment: 482
Study Start Date: January 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
HIV-1 patients treated with antiretroviral combination therapy that includes raltegravir
 Drug: raltegravir
HIV-1 patients treated with antiretroviral combination therapy that includes raltegravir
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
Study Population

Patient Infected With HIV-1

Criteria

Inclusion Criteria:

  • Patient Infected With HIV-1.
  • Patient for whom raltegravir therapy has been decided and started less than 30 days prior to inclusion in the study.
  • Patient who has received oral and written information about the study and who has agreed to the computer processing of his/her personal data.

Exclusion Criteria:

  • Patient taking part in a clinical trial to assess raltegravir.
  • Patient in whom raltegravir treatment was started more than 30 days ago.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01048671

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT01048671     History of Changes
Other Study ID Numbers: 2010_002, MK0518-138
Study First Received: January 12, 2010
Last Updated: January 24, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Merck:
HIV

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 16, 2013