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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:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01048671
First received: January 12, 2010
Last updated: June 23, 2014
Last verified: June 2014

January 12, 2010
June 23, 2014
January 2010
December 2012   (final data collection date for primary outcome measure)
  • Percentage of Participants Receiving Antiretroviral Treatments Administered With Raltegravir [ Time Frame: Up to 25 months after start of raltegravir treatment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
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 ]
Complete list of historical versions of study NCT01048671 on ClinicalTrials.gov Archive Site
Number of Participants With at Least One Adverse Event [ Time Frame: Up to 25 months after start of raltegravir treatment ] [ Designated as safety issue: Yes ]
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.
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 ]
Not Provided
Not Provided
 
Management of Human Immunodeficiency Virus 1 (HIV-1) Participants Treated With Antiretroviral (ARV) Combination Therapy Including Raltegravir (MK-0518-138)
Collection of Data on the Management of HIV-1 Patients Treated With Antiretroviral Combination Therapy Including the HIV Integrase Inhibitor Raltegravir

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

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Participant Infected With HIV-1

HIV Infections
  • 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.
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.
Interventions:
  • Drug: Raltegravir
  • Drug: ARV (non-raltegravir)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
482
December 2012
December 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01048671
0518-138, MK0518-138
Yes
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP