Safety and Efficacy of an Investigational Drug in Human Immunodeficiency Virus (HIV)-Infected Patients Failing Current Antiretroviral Therapies

This study has been completed.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00105157

First received: March 8, 2005

Last updated: June 17, 2010

Last verified: June 2010

History of Changes

Purpose

This study will investigate the safety and efficacy of different doses of an investigational drug (MK0518) as a therapy for HIV-infected patients failing current antiretroviral therapies.

Condition	Intervention	Phase
HIV Infections Acquired Immunodeficiency Syndrome	Drug: Comparator: MK0518 Drug: MK0518 Drug: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Multicenter Study to Evaluate the Safety and Efficacy of MK0518 in Combination With An Optimized Background Therapy (OBT), Versus OBT Alone, in HIV-Infected Patients With Documented Resistance

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Raltegravir Raltegravir potassium

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Change From Baseline in Plasma HIV RNA (log10 Copies/mL) at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
Mean change from baseline at Week 24 in HIV RNA (log10 copies/mL) in all patients

Secondary Outcome Measures:

Number of Patients With Virologic Responses at Week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Number of patients who achieve HIV RNA <400 copies/mL; HIV RNA level <50 copies/mL at Week 24; or reduction from baseline in HIV RNA (log10 copies/mL) exceeding 1.0 log10 copies/mL at Week 24; at Week 24
Change From Baseline in CD4 Cell Count at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
Mean change from baseline at Week 24 in CD4 Cell Count (cells/mm3)
Number of Patients With Clinical Adverse Experiences (CAEs) at 48 Weeks [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
An adverse experience (AE) 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 product, whether or not considered related to the use of the product
Number of Patients With Serious CAEs at 48 Weeks [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
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 at 48 Weeks [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs
Number of Patients With Serious Drug-related CAEs at 48 Weeks [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
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 judgment.
Number of Patients That Died by 48 Weeks [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
Number of Patients That Discontinued With CAEs at 48 Weeks [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
Number of Patients That Discontinued With Drug-related CAEs at 48 Weeks [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
Number of Patients That Discontinued With Serious CAEs at 48 Weeks [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
Number of Patients That Discontinued With Serious Drug-related CAEs at 48 Weeks [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
Number of Patients With Laboratory Adverse Experiences (LAEs) at 48 Weeks [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
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 product, whether or not considered related to the use of the product
Number of Patients With Drug-related LAEs at 48 Weeks [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs
Number of Patients Discontinued With Laboratory Adverse Experiences (LAEs) at 48 Weeks [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
Number of Patients Discontinued With Drug-related LAEs at 48 Weeks [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
Number of Patients With Clinical Adverse Experiences (CAEs) at 96 Weeks [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
An adverse experience (AE) 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 product, whether or not considered related to the use of the product
Number of Patients With Serious CAEs at 96 Weeks [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
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 at 96 Weeks [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs
Number of Patients With Serious Drug-related CAEs at 96 Weeks [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
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 judgment.
Number of Patients That Died by 96 Weeks [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
Number of Patients That Discontinued With CAEs at 96 Weeks [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
Number of Patients That Discontinued With Drug-related CAEs at 96 Weeks [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
Number of Patients That Discontinued With Serious CAEs at 96 Weeks [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
Number of Patients That Discontinued With Serious Drug-related CAEs at 96 Weeks [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
Number of Patients With Laboratory Adverse Experiences (LAEs) at 96 Weeks [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
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 product, whether or not considered related to the use of the product
Number of Patients With Drug-related LAEs at 96 Weeks [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs
Number of Patients Discontinued With Laboratory Adverse Experiences (LAEs) at 96 Weeks [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
Number of Patients Discontinued With Drug-related LAEs at 96 Weeks [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
Number of Patients With Clinical Adverse Experiences (CAEs) at 168 Weeks [ Time Frame: 168 weeks ] [ Designated as safety issue: Yes ]
An adverse experience (AE) 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 product, whether or not considered related to the use of the product
Number of Patients With Serious CAEs at 168 Weeks [ Time Frame: 168 weeks ] [ Designated as safety issue: Yes ]
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 at 168 Weeks [ Time Frame: 168 weeks ] [ Designated as safety issue: Yes ]
Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs
Number of Patients With Serious Drug-related CAEs at 168 Weeks [ Time Frame: 168 weeks ] [ Designated as safety issue: Yes ]
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 judgment.
Number of Patients That Died by 168 Weeks [ Time Frame: 168 weeks ] [ Designated as safety issue: Yes ]
Number of Patients That Discontinued With CAEs at 168 Weeks [ Time Frame: 168 weeks ] [ Designated as safety issue: Yes ]
Number of Patients That Discontinued With Drug-related CAEs at 168 Weeks [ Time Frame: 168 weeks ] [ Designated as safety issue: Yes ]
Number of Patients That Discontinued With Serious CAEs at 168 Weeks [ Time Frame: 168 weeks ] [ Designated as safety issue: Yes ]
Number of Patients That Discontinued With Serious Drug-related CAEs at 168 Weeks [ Time Frame: 168 weeks ] [ Designated as safety issue: Yes ]
Number of Patients With Laboratory Adverse Experiences (LAEs) at 168 Weeks [ Time Frame: 168 weeks ] [ Designated as safety issue: Yes ]
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 product, whether or not considered related to the use of the product
Number of Patients With Serious LAEs at 168 Weeks [ Time Frame: 168 weeks ] [ Designated as safety issue: Yes ]
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 Discontinued With Drug-related LAEs at 168 Weeks [ Time Frame: 168 weeks ] [ Designated as safety issue: Yes ]
Number of Patients With Drug-related LAEs at 168 Weeks [ Time Frame: 168 weeks ] [ Designated as safety issue: Yes ]
Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs
Number of Patients With Serious Drug-related LAEs at 168 Weeks [ Time Frame: 168 weeks ] [ Designated as safety issue: Yes ]
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 Discontinued With LAEs at 168 Weeks [ Time Frame: 168 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	179
Study Start Date:	March 2005
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 MK0518 200 mg	Drug: Comparator: MK0518 MK0518 oral tablets 200 mg b.i.d, for 24 weeks Other Name: MK0518
Experimental: 2 MK0518 400 mg	Drug: MK0518 MK0518 oral tablets 400 mg b.i.d, for 24 weeks Other Name: MK0518
Experimental: 3 MK0518 600 mg	Drug: MK0518 MK0518 oral tablets 600 mg b.i.d, for 24 weeks Other Name: MK0518
Placebo Comparator: 4 Placebo	Drug: Placebo Placebo to MK0518, oral tablet b.i.d, for 24 weeks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient must be HIV positive with Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) values that are within ranges required by the study
Patient must be currently on antiretroviral therapy (ART)

Exclusion Criteria:

Patient less than 18 years of age
Additional exclusion criteria will be discussed and identified by the study doctor

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00105157

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Publications:

Grinsztejn B, Nguyen BY, Katlama C, Gatell JM, Lazzarin A, Vittecoq D, Gonzalez CJ, Chen J, Harvey CM, Isaacs RD; Protocol 005 Team. Safety and efficacy of the HIV-1 integrase inhibitor raltegravir (MK-0518) in treatment-experienced patients with multidrug-resistant virus: a phase II randomised controlled trial. Lancet. 2007 Apr 14;369(9569):1261-9.

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00105157 History of Changes
Other Study ID Numbers:	2005_007, MK0518-005
Study First Received:	March 8, 2005
Results First Received:	September 14, 2009
Last Updated:	June 17, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections

Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 22, 2013

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