A Study of Raltegravir in a Diverse Cohort of HIV-Infected Patients (0518-055)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Human Immunodeficiency Virus

Treatments: Drug: Comparator: raltegravir

Study type: Interventional

Funder types: Industry

Identifiers

NCT00764946

0518-055

2008_555

Details and patient eligibility

About

A study to test the safety and effect of twice daily raltegravir in a diverse cohort of patients currently infected with human immunodeficiency virus (HIV), where at least 50% are African American and at least 25% are female, either having received antiretroviral drugs before or not.

Enrollment: 209 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient is HIV positive
• Patient agrees to use (or have their partner use) birth control as defined by the study doctor

Exclusion criteria

• If female, pregnant or breastfeeding
• Patient has used an investigational agent in the last 30 days
• Patient has acute hepatitis
• Patient has received MK0518 (raltegravir) before
• Patient has used another experimental HIV-integrase inhibitor

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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209 participants in 1 patient group

1

Experimental group

Description:

raltegravir

Treatment:

Drug: Comparator: raltegravir