Post-Licensure Safety Study of ISENTRESS™ (Raltegravir) in a United States Managed Care Network (MK-0518-268)

Merck Sharp & Dohme (MSD)

Status: Completed

Conditions: HIV-1 Infections

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01078246

2010_021 (Other Identifier)

EP08025.006 (Other Identifier)

0518-268

Details and patient eligibility

About

The objective of this study is to monitor Health Outcomes of Interest (HOI) in participants with human immunodeficiency virus-1 (HIV-1) infection following treatment with Raltegravir.

Full description

Study participants contributed data to one or more of 3 cohorts: 1) Historical Cohort: HIV-infected participants treated with antiretroviral therapy in the course of ordinary clinical practice at the clinics and medical centers of Kaiser Permanente (KP) between 1 January 2000 and 12 October 2007 (date of market authorization for raltegravir in USA), 2) Concurrent Cohort: HIV-infected participant treated with a new non-raltegravir antiretroviral therapy in the course of ordinary clinical practice at the clinics and medical centers of KP on or after 12 October 2007, and 3) Raltegravir Cohort: HIV-infected participant treated with raltegravir in the course of ordinary clinical practice at the clinics and medical centers of KP on or after 12 October 2007. Participants could contribute data to more than one cohort, but no overlap in follow-up time was allowed.

Enrollment: 7,124 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Historical Cohort: HIV-infected participant treated with antiretroviral therapy in the course of ordinary clinical practice at the clinics and medical centers of Kaiser Permanente (KP) between 1 January 2000 and 12 October 2007 (date of market authorization for raltegravir in USA)
• Raltegravir Cohort: HIV-infected participant treated with raltegravir in the course of ordinary clinical practice at the clinics and medical centers of KP on or after 12 October 2007
• Concurrent Cohort: HIV-infected participant treated with a new non-raltegravir antiretroviral therapy in the course of ordinary clinical practice at the clinics and medical centers of KP on or after 12 October 2007
• All participants must have at least one year of continuous membership with KP prior to date when the participant received the first dispensed prescription for study drug (index date) to allow for the assessment of medical and treatment history

Exclusion criteria

• Less than 18 years of age
• Do not receive their medications through the KP pharmacy system
• Do not receive their laboratory examinations through the KP system
• Participating in the raltegravir phase III or expanded access program

Trial design

7,124 participants in 7 patient groups

Raltegravir Cohort Only

Description:

Participants with HIV-1 infection who received raltegravir (RAL) on or after 12 October 2007 (the market authorization date in the United States) (Raltegravir Cohort). These participants contributed data to the Raltegravir Cohort only.

Historical and Raltegravir Cohorts Only

Description:

Participants with HIV-1 infection who 1) received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007 (Historical Cohort), and 2) received RAL on or after 12 October 2007 (Raltegravir Cohort). These participants contributed data to the Historical and Raltegravir Cohorts only.

Historical Cohort Only

Description:

Participants with HIV-1 infection who received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007 (Historical Cohort). These participants contributed data to the Historical Cohort only.

Historical and Concurrent Cohorts Only

Description:

Participants with HIV-1 infection who 1) received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007 (Historical Cohort), and 2) received therapy with a new non-RAL antiretroviral therapy after 12 October 2007 (Concurrent Cohort). These participants contributed data to the Historical and Concurrent Cohorts only.

Concurrent Cohort Only

Description:

Participants with HIV-1 infection who received therapy with a new non-RAL antiretroviral therapy after 12 October 2007 (Concurrent Cohort). These participants contributed data to the Concurrent Cohort only.

Concurrent and Raltegravir Cohorts Only

Description:

Participants with HIV-1 infection who 1) received therapy with a new non-RAL antiretroviral therapy on or after 12 October 2007 (Concurrent Cohort), and 2) received RAL after 12 October 2007 (Raltegravir Cohort). These participants contributed data to the Concurrent and Raltegravir Cohorts only.

Historical, Concurrent and Raltegravir Cohorts

Description:

Participants with HIV-1 infection who 1) received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007 (Historical Cohort), 2) received therapy with a new non-RAL antiretroviral therapy on or after 12 October 2007 (Concurrent Cohort), and 3) received RAL after 12 October 2007 (Raltegravir Cohort). These participants contributed data to all three cohorts.