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

NCT00443703 | Terminated Phase 3 Results

• 2 other identifiers: 0518-0322007_507
• Study Type: interventional
• Target: 352
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

HIV Infection

Keywords

treatment experienced

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (5)

• 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

  Baseline and Week 24

Other Outcomes (11)

• Number of Patients With Serious CAEs Through 24 Weeks

  24 Week last patient last visit

• Number of Patients With Drug-related CAEs Through 24 Weeks

  24 Week last patient last visit

• Number of Patients With Serious Drug-related CAEs Through 24 Weeks

  24 Week last patient last visit

Study Arms (2)

1

EXPERIMENTAL

Arm 1: MK0518 (raltegravir) + placebo to KALETRA™ (lopinavir (+) ritonavir )

Drug: MK0518 (raltegravir); Drug: Comparator: placebo

2

ACTIVE COMPARATOR

Arm 2: KALETRA™ (lopinavir (+) ritonavir) + placebo to MK0518 (raltegravir)

Drug: Comparator: KALETRA™ (lopinavir (+) ritonavir ); Drug: Comparator: placebo

Interventions

MK0518 (raltegravir) DRUG

MK0518 (raltegravir) 400 mg by mouth (PO) twice daily (b.i.d) for up to 48 weeks of treatment

Also known as: MK0518, raltegravir

1

Comparator: KALETRA™ (lopinavir (+) ritonavir ) DRUG

KALETRA™ (lopinavir (+) ritonavir ) 400/100 mg by mouth (PO) twice daily (b.i.d.) for up to 48 weeks of treatment.

Also known as: KALETRA

2

Comparator: placebo DRUG

MK0518 (raltegravir) 400 mg by mouth (PO) twice daily (b.i.d.) Placebo for up to 48 weeks of treatment

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Eron JJ, Young B, Cooper DA, Youle M, Dejesus E, Andrade-Villanueva J, Workman C, Zajdenverg R, Fatkenheuer G, Berger DS, Kumar PN, Rodgers AJ, Shaughnessy MA, Walker ML, Barnard RJ, Miller MD, Dinubile MJ, Nguyen BY, Leavitt R, Xu X, Sklar P; SWITCHMRK 1 and 2 investigators. Switch to a raltegravir-based regimen versus continuation of a lopinavir-ritonavir-based regimen in stable HIV-infected patients with suppressed viraemia (SWITCHMRK 1 and 2): two multicentre, double-blind, randomised controlled trials. Lancet. 2010 Jan 30;375(9712):396-407. doi: 10.1016/S0140-6736(09)62041-9. Epub 2010 Jan 12.

  PMID: 20074791 DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

Raltegravir Potassium; Lopinavir; Ritonavir; lopinavir-ritonavir drug combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidinones; Pyrimidines; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles

Limitations and Caveats

The reason for early termination: Study was terminated after the primary efficacy analysis at Week 24 did not demonstrate non-inferiority of MK0518 versus KALETRA™.

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2007
• First Posted: March 6, 2007
• Study Start: May 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: March 21, 2017
• Results First Posted: December 1, 2009

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will share