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

Overview

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

Full Title of Study: “Collection of Data on the Management of HIV-1 Patients Treated With Antiretroviral Combination Therapy Including the HIV Integrase Inhibitor Raltegravir”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2012

Interventions

  • 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.
  • 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.

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary 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 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Merck Sharp & Dohme Corp.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Medical Monitor, Study Director, Merck Sharp & Dohme Corp.

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