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

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

Official Title
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Collection of Data on the Management of HIV-1 Patients Treated With Antiretroviral Combination Therapy Including the HIV Integrase Inhibitor Raltegravir

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Raltegravir
* Drug: ARV (non-raltegravir)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Antiretroviral combination therapy including raltegravir<br>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<br>* 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.<br>* Other names: Isentress;Drug: ARV (non-raltegravir)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Receiving Antiretroviral Treatments Administered With 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. 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. | Up to 25 months after start of raltegravir treatment | 
| Percentage of Participants Responding to Treatment: All Treated Participants | Response to treatment was defined as a viral load <50 RNA copies/mL | 24 months after start of raltegravir treatment | 
| Percentage of Participants Responding to Treatment: Participants Still Receiving Raltegravir Treatment at Month 24 | Response to treatment was defined as a viral load <50 RNA copies/mL | 24 months after start of raltegravir treatment | 
| Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count: All Treated Participants |  | 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 |  | Baseline and 24 months after start of raltegravir treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With at Least One Adverse Event | 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. | Up to 25 months after start of raltegravir treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV