A Study to Evaluate the Safety and Efficacy of Raltegravir (MK0518) in HIV-Infected Patients Failing Current Antiretroviral Therapies (0518-019) - 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:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS Potassium

Drug Information available for: Raltegravir Raltegravir potassium Potassium chloride

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Number 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 ]
Mean change from baseline at Week 16 in HIV RNA (log10 copies/mL)
Change From Baseline in HIV RNA at Week 48 [ Time Frame: Baseline and Week 48 ] [ Designated as safety issue: No ]
Mean change from baseline at Week 48 in HIV RNA (log10 copies/mL)
Change From Baseline in CD4 Cell Count at Week 16 [ Time Frame: Baseline and Week 16 ] [ Designated as safety issue: No ]
Mean change from baseline at Week 16 in CD4 Cell Count (cells/mm^3)
Change From Baseline in CD4 Cell Count at Week 48 [ Time Frame: Baseline and Week 48 ] [ Designated as safety issue: No ]
Mean change from baseline at Week 48 in CD4 Cell Count (cells/mm^3)

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

Arms	Assigned Interventions
Experimental: 1 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. Other Name: ISENTRESS
Placebo Comparator: 2 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:	Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00293254 History of Changes
Other Study ID Numbers:	2005_097, MK0518-019
Study First Received:	February 15, 2006
Results First Received:	August 20, 2009
Last Updated:	June 8, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

Treatment Experienced

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases

Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on February 09, 2012