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

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

Official Title
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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

Conditions
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HIV Infection

Intervention / Treatment
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* Drug: MK0518 (raltegravir)
* Drug: Comparator: KALETRA™ (lopinavir (+) ritonavir )
* Drug: Comparator: placebo
* Drug: Comparator: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Arm 1: MK0518 (raltegravir) + placebo to KALETRA™ (lopinavir (+) ritonavir ) | Drug: MK0518 (raltegravir)<br>* MK0518 (raltegravir) 400 mg by mouth (PO) twice daily (b.i.d) for up to 48 weeks of treatment<br>* Other names: raltegravir;Drug: Comparator: placebo<br>* KALETRA™ (lopinavir (+) ritonavir ) 400/100 mg by mouth (PO) twice daily (b.i.d.) Placebo for up to 48 weeks of treatment.<br>|
| Active Comparator: 2<br>Arm 2: KALETRA™ (lopinavir (+) ritonavir) + placebo to MK0518 (raltegravir) | Drug: Comparator: KALETRA™ (lopinavir (+) ritonavir )<br>* KALETRA™ (lopinavir (+) ritonavir ) 400/100 mg by mouth (PO) twice daily (b.i.d.) for up to 48 weeks of treatment.<br>* Other names: KALETRA;Drug: Comparator: placebo<br>* MK0518 (raltegravir) 400 mg by mouth (PO) twice daily (b.i.d.) Placebo for up to 48 weeks of treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Plasma Human Immunodeficiency Virus (HIV) RiboNucleic Acid (RNA) <50 Copies/mL at Week 24 |  | Week 24 | 
| 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 | 
| Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 12 |  | Baseline and Week 12 | 
| Mean Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12 |  | Baseline and Week 12 | 
| Mean Percent Change From Baseline in Fasting Serum Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 |  | Baseline and Week 12 | 
| Mean Percent Change From Baseline in Fasting Serum High-Density Lipoprotein Cholesterol (HDL-C) at Week 12 |  | Baseline and Week 12 | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 24 |  | Baseline and Week 24 | 
| Mean Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 |  | Baseline and Week 24 | 
| Mean Percent Change From Baseline in Fasting Serum Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24 |  | Baseline and Week 24 | 
| Mean Percent Change From Baseline in Fasting Serum High-Density Lipoprotein Cholesterol (HDL-C) at Week 24 |  | Baseline and Week 24 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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treatment experienced