MK0518 in the Treatment of HIV-Infected Patients Switched From a Protease Inhibitor Regimen (0518-032)(TERMINATED)
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ClinicalTrials.gov Identifier: NCT00443703 |
Recruitment Status
:
Terminated
(primary efficacy analysis at Week 24 did not demonstrate non-inferiority of raltegravir versus lopinavir (+) ritonavir)
First Posted
: March 6, 2007
Results First Posted
: December 1, 2009
Last Update Posted
: March 21, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infection | Drug: MK0518 (raltegravir) Drug: Comparator: KALETRA™ (lopinavir (+) ritonavir ) Drug: Comparator: placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 352 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | May 2007 |
Actual Primary Completion Date : | April 2009 |
Actual Study Completion Date : | April 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
Arm 1: MK0518 (raltegravir) + placebo to KALETRA™ (lopinavir (+) ritonavir )
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Drug: MK0518 (raltegravir)
MK0518 (raltegravir) 400 mg by mouth (PO) twice daily (b.i.d) for up to 48 weeks of treatment
Other Names:
Drug: Comparator: placebo
KALETRA™ (lopinavir (+) ritonavir ) 400/100 mg by mouth (PO) twice daily (b.i.d.) Placebo for up to 48 weeks of treatment.
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Active Comparator: 2
Arm 2: KALETRA™ (lopinavir (+) ritonavir) + placebo to MK0518 (raltegravir)
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Drug: 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.
Other Name: KALETRA
Drug: Comparator: placebo
MK0518 (raltegravir) 400 mg by mouth (PO) twice daily (b.i.d.) Placebo for up to 48 weeks of treatment
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- Number of Patients With Plasma Human Immunodeficiency Virus (HIV) RiboNucleic Acid (RNA) <50 Copies/mL at Week 24 [ Time Frame: Week 24 ]
- Number of Patients With Clinical Adverse Experiences (CAEs) Through 24 Weeks [ Time Frame: 24 Week last patient last visit ]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
- Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 12 [ Time Frame: Baseline and Week 12 ]
- Mean Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12 [ Time Frame: Baseline and Week 12 ]
- Mean Percent Change From Baseline in Fasting Serum Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 [ Time Frame: Baseline and Week 12 ]
- Mean Percent Change From Baseline in Fasting Serum High-Density Lipoprotein Cholesterol (HDL-C) at Week 12 [ Time Frame: Baseline and Week 12 ]
- Median Percent Change From Baseline in Serum Triglyceride at Week 12 [ Time Frame: Baseline and Week 12 ]Standard Deviation (Robust): calculated as interquartile range (IQR)/1.075, where IQR=3rd quartile-1st quartile.
- Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 24 [ Time Frame: Baseline and Week 24 ]
- Mean Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 [ Time Frame: Baseline and Week 24 ]
- Mean Percent Change From Baseline in Fasting Serum Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24 [ Time Frame: Baseline and Week 24 ]
- Mean Percent Change From Baseline in Fasting Serum High-Density Lipoprotein Cholesterol (HDL-C) at Week 24 [ Time Frame: Baseline and Week 24 ]
- Median Percent Change From Baseline in Serum Triglyceride at Week 24 [ Time Frame: Baseline and Week 24 ]Standard Deviation (Robust): calculated as interquartile range (IQR)/1.075, where IQR=3rd quartile-1st quartile.
- Number of Patients With Serious CAEs Through 24 Weeks [ Time Frame: 24 Week last patient last visit ]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
- Number of Patients With Drug-related CAEs Through 24 Weeks [ Time Frame: 24 Week last patient last visit ]Patients with drug-related (as assessed by an investigator who is a qualified physician, according to his/her best clinical judgement) CAEs.
- Number of Patients With Serious Drug-related CAEs Through 24 Weeks [ Time Frame: 24 Week last patient last visit ]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
- Number of Patients That Died by 24 Week Last Patient Last Visit [ Time Frame: 24 Week last patient last visit ]
- Number of Patients That Discontinued Due to CAEs Through 24 Weeks [ Time Frame: 24 Week last patient last visit ]
- Number of Patients That Discontinued Due to Drug Related CAEs Through 24 Weeks [ Time Frame: 24 Week last patient last visit ]
- Number of Patients With Laboratory Adverse Experiences (LAEs) Through 24 Weeks [ Time Frame: 24 Week last patient last visit ]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
- Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) Through 24 Weeks [ Time Frame: 24 Week last patient last visit ]Patients with drug-related (as assessed by an investigator who is a qualified physician, according to his/her best clinical judgement) LAEs
- Number of Patients With Serious LAEs Through 24 Weeks [ Time Frame: 24 Week last patient last visit ]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
- Number of Patients That Discontinued Due to LAEs Through 24 Weeks [ Time Frame: 24 Week last patient last visit ]
- Number of Patients That Discontinued With Drug Related LAEs Through 24 Weeks [ Time Frame: 24 Week last patient last visit ]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.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00443703
Study Director: | Medical Monitor | Merck Sharp & Dohme Corp. |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Merck Sharp & Dohme Corp. |
ClinicalTrials.gov Identifier: | NCT00443703 History of Changes |
Other Study ID Numbers: |
0518-032 2007_507 |
First Posted: | March 6, 2007 Key Record Dates |
Results First Posted: | December 1, 2009 |
Last Update Posted: | March 21, 2017 |
Last Verified: | February 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php |
Keywords provided by Merck Sharp & Dohme Corp.:
treatment experienced |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Ritonavir Lopinavir Raltegravir Potassium |
Protease Inhibitors HIV Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors HIV Integrase Inhibitors Integrase Inhibitors |