MK0518 in the Treatment of HIV-Infected Patients Switched From a Protease Inhibitor Regimen (0518-032)(TERMINATED)

• Status: Terminated
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Lopinavir; Protease Inhibitors; Raltegravir Potassium; Ritonavir

Criteria

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 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

• Patient has used systemic immunosuppressive therapy within one month prior to treatment in this study