Safety and Efficacy of an Investigational Drug in HIV-Infected Patients Failing Current Antiretroviral Therapies - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00105157

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: Comparator: Placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: AIDS

Drug Information available for: Raltegravir

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 in Combined Substudies [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of Patients With Virologic Responses at Week 24 in Combined Substudies [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Change from baseline in CD4 Cell Count at Week 24 in Combined Substudies [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Number of patients with clinical adverse experiences (CAEs) at 48 weeks [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
Number of patients with serious CAEs at 48 weeks [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
Number of patients with drug-related CAEs at 48 weeks [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
Number of patients with serious drug-related CAEs at 48 weeks [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
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 ]
Number of patients with drug-related LAEs at 48 weeks [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
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 ]
Number of patients with serious CAEs at 96 weeks [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
Number of patients with drug-related CAEs at 96 weeks [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
Number of patients with serious drug-related CAEs at 96 weeks [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
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 ]
Number of patients with drug-related LAEs at 96 weeks [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
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 ]

Enrollment:	200
Study Start Date:	March 2005
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental MK0518 200 mg	Drug: Comparator: MK0518 MK0518 oral tablets 200, 400 or 600 mg b.i.d, for 24 weeks
2: Experimental MK0518 400 mg	Drug: Comparator: MK0518 MK0518 oral tablets 200, 400 or 600 mg b.i.d, for 24 weeks
3: Experimental MK0518 600 mg	Drug: Comparator: MK0518 MK0518 oral tablets 200, 400 or 600 mg b.i.d, for 24 weeks
4: Placebo Comparator Placebo	Drug: Comparator: 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 HIV 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:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2005_007, MK0518-005
Study First Received:	March 8, 2005
Last Updated:	August 19, 2009
ClinicalTrials.gov Identifier:	NCT00105157 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

RNA Virus Infections
Sexually Transmitted Diseases, Viral
Disease
Slow Virus Diseases
Immune System Diseases
Acquired Immunodeficiency Syndrome
Infection
Immunologic Deficiency Syndromes

Virus Diseases
Pathologic Processes
HIV Infections
Syndrome
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on November 05, 2009