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Management of Human Immunodeficiency Virus 1 (HIV-1) Participants Treated With Antiretroviral (ARV) Combination Therapy Including Raltegravir (MK-0518-138) (RACING)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01048671
First Posted: January 14, 2010
Last Update Posted: October 30, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
To evaluate the management of HIV-1 participants treated with antiretroviral combination therapy including the integrase inhibitor raltegravir, all across the country of France.

Condition Intervention
HIV Infections Drug: Raltegravir Drug: ARV (non-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 HIV Integrase Inhibitor Raltegravir

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Percentage of Participants Receiving Antiretroviral Treatments Administered With Raltegravir [ Time Frame: Up to 25 months after start of raltegravir treatment ]
    Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting. ARV treatments included any nucleoside reverse transcriptase inhibitors (NRTIs), combination of tenovir/emitricitabine (FTC/TDF), combination of lamivudine/abacavir (3TC/ABC), protease inhibitors, and others.

  • Percentage of Participants Responding to Treatment: All Treated Participants [ Time Frame: 24 months after start of raltegravir treatment ]
    Response to treatment was defined as a viral load <50 RNA copies/mL

  • Percentage of Participants Responding to Treatment: Participants Still Receiving Raltegravir Treatment at Month 24 [ Time Frame: 24 months after start of raltegravir treatment ]
    Response to treatment was defined as a viral load <50 RNA copies/mL

  • Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count: All Treated Participants [ Time Frame: Baseline and 24 months after start of raltegravir treatment ]
  • Mean Change From Baseline in CD4 Cell Count: Participants Still Receiving Raltegravir Treatment at Month 24 [ Time Frame: Baseline and 24 months after start of raltegravir treatment ]

Secondary Outcome Measures:
  • Number of Participants With at Least One Adverse Event [ Time Frame: Up to 25 months after start of raltegravir treatment ]
    An adverse event was defined as any untoward, undesired, or unplanned clinical event in the form of physical signs, symptoms, disease, laboratory or physiological observations in a participant administered the sponsor's product whether or not related to the use of the product.


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
Antiretroviral combination therapy including raltegravir
Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
Drug: Raltegravir
Raltegravir was administered in combination with ARV therapies at the discretion of the investigator in accordance with the product label. The recommended dose of raltegravir is 400 mg twice daily.
Other Name: Isentress
Drug: ARV (non-raltegravir)
ARV treatments were administered in combination with raltegravir at the discretion of the investigator in accordance with the product labels, and could include nucleoside reverse-transcriptase inhibitor, non-nucleoside reverse-transcriptase inhibitor, protease inhibitor, entry inhibitor, and integrase inhibitor catagories.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participant Infected With HIV-1
Criteria

Inclusion Criteria:

  • Participant Infected With HIV-1.
  • Participant for whom raltegravir therapy has been decided and started less than 30 days prior to inclusion in the study.
  • Participant 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:

  • Participant taking part in a clinical trial to assess raltegravir.
  • Participant in whom raltegravir treatment was started more than 30 days ago.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01048671


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01048671     History of Changes
Other Study ID Numbers: 0518-138
MK0518-138
First Submitted: January 12, 2010
First Posted: January 14, 2010
Results First Submitted: December 23, 2013
Results First Posted: February 14, 2014
Last Update Posted: October 30, 2015
Last Verified: October 2015

Keywords provided by Merck Sharp & Dohme Corp.:
HIV

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Raltegravir Potassium
HIV Integrase Inhibitors
Integrase Inhibitors
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action