A Study to Evaluate the Safety and Efficacy of Raltegravir (MK0518) in HIV-Infected Patients Failing Current Antiretroviral Therapies - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00293254

Purpose

This study will investigate the safety and efficacy of raltegravir as a therapy for Human Immunodeficiency Virus (HIV)-infected patients failing current therapy.

Condition	Intervention	Phase
HIV Infections	Drug: Comparator: raltegravir potassium Drug: Comparator: placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study
Official Title:	A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Antiretroviral Activity of MK0518 in Combination With an Optimized Background Therapy (OBT), Versus Optimized Background Therapy Alone, in HIV-Infected Patients With Documented Resistance to at Least 1 Drug

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Raltegravir Raltegravir potassium Potassium chloride

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Proportion of Patients Achieving HIV RNA <400 Copies/mL at Week 16 [ Time Frame: 16 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change From Baseline in HIV RNA at Week 16 [ Time Frame: Baseline and Week 16 ] [ Designated as safety issue: No ]
Change From Baseline in HIV RNA at Week 48 [ Time Frame: Baseline and Week 48 ] [ Designated as safety issue: No ]
Change From Baseline in CD4 Cell Count at Week 16 [ Time Frame: Baseline and Week 16 ] [ Designated as safety issue: No ]
Change From Baseline in CD4 Cell Count at Week 48 [ Time Frame: Baseline and Week 48 ] [ Designated as safety issue: No ]

Enrollment:	351
Study Start Date:	February 2006
Estimated Study Completion Date:	April 2011
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental raltegravir potassium	Drug: Comparator: raltegravir potassium raltegravir potassium 400 mg tablet by mouth (p.o.) twice a day (b.i.d.) with optimized background therapy. Treatment period of 48 weeks.
2: Placebo Comparator Placebo	Drug: Comparator: placebo Placebo tablets p.o. b.i.d. with optimized background therapy. Treatment period of 48 weeks.

Eligibility

Ages Eligible for Study:	16 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 have documented failure of certain antiretroviral therapy
Patient must be on the same antiretroviral therapy for at least the past two months

Exclusion Criteria:

Patient less than 16 years old
Additional study criteria will be discussed and identified by the study doctor

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00293254

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Publications:

Steigbigel RT, Cooper DA, Kumar PN, Eron JE, Schechter M, Markowitz M, Loutfy MR, Lennox JL, Gatell JM, Rockstroh JK, Katlama C, Yeni P, Lazzarin A, Clotet B, Zhao J, Chen J, Ryan DM, Rhodes RR, Killar JA, Gilde LR, Strohmaier KM, Meibohm AR, Miller MD, Hazuda DJ, Nessly ML, DiNubile MJ, Isaacs RD, Nguyen BY, Teppler H; BENCHMRK Study Teams. Raltegravir with optimized background therapy for resistant HIV-1 infection. N Engl J Med. 2008 Jul 24;359(4):339-54.

Cooper DA, Steigbigel RT, Gatell JM, Rockstroh JK, Katlama C, Yeni P, Lazzarin A, Clotet B, Kumar PN, Eron JE, Schechter M, Markowitz M, Loutfy MR, Lennox JL, Zhao J, Chen J, Ryan DM, Rhodes RR, Killar JA, Gilde LR, Strohmaier KM, Meibohm AR, Miller MD, Hazuda DJ, Nessly ML, DiNubile MJ, Isaacs RD, Teppler H, Nguyen BY; BENCHMRK Study Teams. Subgroup and resistance analyses of raltegravir for resistant HIV-1 infection. N Engl J Med. 2008 Jul 24;359(4):355-65.

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2005_097, MK0518-019
Study First Received:	February 15, 2006
Results First Received:	August 20, 2009
Last Updated:	November 12, 2009
ClinicalTrials.gov Identifier:	NCT00293254 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

Treatment Experienced

Additional relevant MeSH terms:

Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on November 27, 2009