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

HIV Infection Clinical Trial

Official title:

A Multicenter, Double-Blind, Randomized, Active-Controlled Study to Evaluate the Safety and Antiretroviral Activity of MK0518 Versus KALETRA in HIV-Infected Patients Switched From a Stable KALETRA-Based Regimen - Study A

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00443703
• Other study ID #: 0518-032
• Secondary ID: 2007_507
• Status: Terminated
• Phase: Phase 3
• First received: March 2, 2007
• Last updated: October 1, 2015
• Start date: May 2007
• Est. completion date: April 2009

Study information

• Verified date: October 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 352
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infection

Intervention

Drug:
• MK0518 (raltegravir)
MK0518 (raltegravir) 400 mg by mouth (PO) twice daily (b.i.d) for up to 48 weeks of treatment
• Comparator: KALETRA™ (lopinavir (+) ritonavir )
KALETRA™ (lopinavir (+) ritonavir ) 400/100 mg by mouth (PO) twice daily (b.i.d.) for up to 48 weeks of treatment.
• Comparator: placebo
MK0518 (raltegravir) 400 mg by mouth (PO) twice daily (b.i.d.) Placebo for up to 48 weeks of treatment
• Comparator: placebo
KALETRA™ (lopinavir (+) ritonavir ) 400/100 mg by mouth (PO) twice daily (b.i.d.) Placebo for up to 48 weeks of treatment.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Patients With Serious CAEs Through 24 Weeks	Serious CAEs are any AEs occurring at any dose that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose	24 Week last patient last visit	Yes
Other	Number of Patients With Drug-related CAEs Through 24 Weeks	Patients with drug-related (as assessed by an investigator who is a qualified physician, according to his/her best clinical judgement) CAEs.	24 Week last patient last visit	Yes
Other	Number of Patients With Serious Drug-related CAEs Through 24 Weeks	Serious CAEs are any AEs occurring at any dose that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. Drug-related are as assessed by an investigator who is a qualified physician, according to his/her best clinical judgement	24 Week last patient last visit	Yes
Other	Number of Patients That Died by 24 Week Last Patient Last Visit		24 Week last patient last visit	Yes
Other	Number of Patients That Discontinued Due to CAEs Through 24 Weeks		24 Week last patient last visit	Yes
Other	Number of Patients That Discontinued Due to Drug Related CAEs Through 24 Weeks		24 Week last patient last visit	Yes
Other	Number of Patients With Laboratory Adverse Experiences (LAEs) Through 24 Weeks	A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S (Merck & Co., Inc.) product, whether or not considered related to the use of the product	24 Week last patient last visit	Yes
Other	Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) Through 24 Weeks	Patients with drug-related (as assessed by an investigator who is a qualified physician, according to his/her best clinical judgement) LAEs	24 Week last patient last visit	Yes
Other	Number of Patients With Serious LAEs Through 24 Weeks	Serious LAEs are any LAEs occurring at any dose that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose	24 Week last patient last visit	Yes
Other	Number of Patients That Discontinued Due to LAEs Through 24 Weeks		24 Week last patient last visit	Yes
Other	Number of Patients That Discontinued With Drug Related LAEs Through 24 Weeks	Number of patients that discontinued with drug-related (as assessed by an investigator who is a qualified physician, according to his or her clinical judgement) LAEs.	24 Week last patient last visit	Yes
Primary	Number of Patients With Plasma Human Immunodeficiency Virus (HIV) RiboNucleic Acid (RNA) <50 Copies/mL at Week 24		Week 24	No
Primary	Number of Patients With Clinical Adverse Experiences (CAEs) Through 24 Weeks	An adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S (Merck & Co., Inc.) product, whether or not considered related to the use of the product	24 Week last patient last visit	Yes
Primary	Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 12		Baseline and Week 12	Yes
Primary	Mean Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12		Baseline and Week 12	Yes
Primary	Mean Percent Change From Baseline in Fasting Serum Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12		Baseline and Week 12	Yes
Primary	Mean Percent Change From Baseline in Fasting Serum High-Density Lipoprotein Cholesterol (HDL-C) at Week 12		Baseline and Week 12	Yes
Primary	Median Percent Change From Baseline in Serum Triglyceride at Week 12	Standard Deviation (Robust): calculated as interquartile range (IQR)/1.075, where IQR=3rd quartile-1st quartile.	Baseline and Week 12	Yes
Secondary	Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 24		Baseline and Week 24	Yes
Secondary	Mean Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24		Baseline and Week 24	Yes
Secondary	Mean Percent Change From Baseline in Fasting Serum Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24		Baseline and Week 24	Yes
Secondary	Mean Percent Change From Baseline in Fasting Serum High-Density Lipoprotein Cholesterol (HDL-C) at Week 24		Baseline and Week 24	Yes
Secondary	Median Percent Change From Baseline in Serum Triglyceride at Week 24	Standard Deviation (Robust): calculated as interquartile range (IQR)/1.075, where IQR=3rd quartile-1st quartile.	Baseline and Week 24	Yes