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Sponsored by: |
Merck |
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Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00293267 |
This study will investigate the safety and efficacy of raltegravir as a therapy for HIV-infected patients failing current therapy.
Condition | Intervention | Phase |
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HIV Infections |
Drug: raltegravir potassium Drug: Comparator: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Antiretroviral Activity of MK-0518 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 |
Estimated Enrollment: | 352 |
Study Start Date: | March 2006 |
Estimated Study Completion Date: | July 2011 |
Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
raltegravir potassium
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Drug: raltegravir potassium
Raltegravir 400 mg b.i.d. p.o. with optimized background therapy. Treatment period of 48 weeks.
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2: Placebo Comparator
Placebo
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Drug: Comparator: Placebo
Placebo bid p.o. with optimized background therapy. Treatment period of 48 weeks.
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Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences ) |
Study ID Numbers: | 2005_096, MK0518-018 |
Study First Received: | February 14, 2006 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00293267 History of Changes |
Health Authority: | France: Ministry of Health |
Treatment Experienced |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
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 |