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

Completed

• Conditions: HIV Infections
• Interventions: Drug: Raltegravir; Drug: ARV (non-raltegravir)

• Registration Number: NCT01048671
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-12
• Study First Submitted QC: 2010-01-13
• Study First Posted: 2010-01-14
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Results First Submitted: 2013-12-23
• Results First Submitted QC: 2013-12-23
• Results First Posted: 2014-02-14
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-29
• Last Update Posted: 2015-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 482

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Antiretroviral combination therapy including raltegravir	ARV (non-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.
Antiretroviral combination therapy including raltegravir	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.

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count: All Treated Participants	Baseline and 24 months after start of raltegravir treatment
Percentage of Participants Receiving Antiretroviral Treatments Administered With Raltegravir	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	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	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 CD4 Cell Count: Participants Still Receiving Raltegravir Treatment at Month 24	Baseline and 24 months after start of raltegravir treatment

Secondary Outcome Measures

Name	Time	Method
Number of Participants With at Least One Adverse Event	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.