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

Merck Sharp & Dohme LLC482 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

482

Conditions

HIV Infections

Interventions

RaltegravirDRUG

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.

ARV (non-raltegravir)DRUG

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

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 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

Time frame: 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

Time frame: 24 months after start of raltegravir treatment

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 Outcomes

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.

Data from ClinicalTrials.gov

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