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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 MK-0518 as a therapy for HIV-infected patients failing current therapy.
Condition | Intervention | Phase |
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HIV Infections |
Drug: MK0518 / Duration of Treatment - 48 Weeks Drug: Placebo & Optimized Antiretroviral Background Therapy / Duration of Treatment - 48 Weeks |
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 in Each of the 3 Classes of Licensed Oral Antiretroviral Therapies |
Enrollment: | 345 |
Study Start Date: | February 2006 |
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: | October 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00293267 |
Health Authority: | Italy: National Monitoring Centre for Clinical Trials - Ministry of Health |
Treatment Experienced |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |