MK0518 in the Treatment of HIV-Infected Patients Switched From a Protease Inhibitor Regimen (0518-033)(TERMINATED)

Merck Sharp & Dohme (MSD)

Status and phase

Terminated

Phase 3

Conditions

HIV Infection

Treatments

Drug: Comparator: lopinavir (+) ritonavir

Drug: Comparator: placebo

Drug: Comparator: raltegravir

Study type

Interventional

Funder types

Industry

Identifiers

NCT00443729

2007_508

0518-033

Details and patient eligibility

About

The purpose of this study is to investigate the efficacy, safety, and tolerability of an investigational treatment for patients with Human Immunodeficiency Virus (HIV).

Enrollment

355 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient is at least 18 years of age
Patient is human immunodeficiency virus (HIV) positive
Patient has documented Human Immunodeficiency Virus (HIV) RiboNucleic Acid (RNA) <50 copies/milliliter (mL) for at least 3 months while on a KALETRA based regimen
Patient has been on a KALETRA based regimen for at least 3 months without a change in background antiretroviral therapy
Patient has no documentation of HIV RNA >50 copies/mL for at least 3 months while on the KALETRA based regimen

Exclusion criteria

Patient is or plans to become pregnant, or is nursing a child
Patient plans to donate eggs or impregnate/donate sperm
Patient is receiving Stavudine (d4T) as a component of the background antiretroviral therapy
Patient is currently receiving a second protease inhibitor in addition to KALETRA
Patient is currently receiving, or has received in the past twelve weeks, treatment for the management of elevated lipids
Patient has used another experimental HIV-integrase inhibitor
Patient has a current (active) diagnosis of acute hepatitis due to any cause