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

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

Purpose

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

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

MedlinePlus related topics: AIDS

Drug Information available for: Raltegravir Raltegravir potassium Potassium chloride

U.S. FDA Resources

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

Further study details as provided by Merck:

Primary Outcome Measures:

Proportion of patients achieving HIV RNA <400 copies/mL at Week 16; safety and tolerability assessed by review of the accumulated safety data. [ Time Frame: 16 Weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

At Week 16 and Week 48: (a) Proportion of patients with virologic response at week 16; (b) Change from baseline in HIV RNA (log10 copies/mL); (c) Change from baseline in CD4 cell count. (2) Evaluate the antiretroviral activity at Week 48. [ Time Frame: 16 and 48 Weeks ] [ Designated as safety issue: No ]

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

Arms	Assigned Interventions
1: Experimental raltegravir potassium	Drug: Comparator: raltegravir potassium raltegravir potassium 400 mg tablet P.O. 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.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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
Last Updated:	January 23, 2009
ClinicalTrials.gov Identifier:	NCT00293254 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

Treatment Experienced

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

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 May 07, 2009