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Clinical Trials

MainTitle

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
Merck Sharp & Dohme Corp.


Information provided by (Responsible Party)
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier
NCT01048671

First received: January 12, 2010
Last updated: October 29, 2015
Last Verified: October 2015
History of Changes
Purpose

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

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)

Arms 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

Eligibility

Ages Eligible for Study: 18 Years and older  
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

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01048671

Sponsors and Collaborators

Merck Sharp & Dohme Corp.

Investigators

Study Director: Medical Monitor Merck Sharp & Dohme Corp.
More Information

More Information


Responsible Party: Merck Sharp & Dohme Corp.  
ClinicalTrials.gov Identifier: NCT01048671   History of Changes  
Other Study ID Numbers: 0518-138  
  MK0518-138  
Study First Received: January 12, 2010  
Last Updated: October 29, 2015  

Keywords provided by Merck Sharp & Dohme Corp.:

HIV

Additional relevant MeSH terms:
HIV Infections
Raltegravir Potassium
HIV Integrase Inhibitors
Integrase Inhibitors

ClinicalTrials.gov processed this data on October 19, 2017
This information is provided by ClinicalTrials.gov.