A Study to Evaluate the Safety and Efficacy of MK-0518 in HIV-Infected Patients Failing Current Antiretroviral Therapies - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00293267

Purpose

This study will investigate the safety and efficacy of MK-0518 as a therapy for HIV-infected patients failing current therapy.

Condition	Intervention	Phase
HIV Infections	Drug: MK0518 / Duration of Treatment - 48 Weeks Drug: Placebo & Optimized Antiretroviral Background Therapy / Duration of Treatment - 48 Weeks	Phase III

MedlinePlus related topics: AIDS

Drug Information available for: Raltegravir

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

Further study details as provided by Merck:

Primary Outcome Measures:

Proportion of patients achieving HIV RNA <400 copies/mL at Weeks 24; safety and tolerability assessed by review of the accumulated safety data.

Secondary Outcome Measures:

At Week 24 and Week 48: (a) Proportion of patients with virologic response at week 24; (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.

Enrollment:	345
Study Start Date:	February 2006

Eligibility

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:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00293267

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Publications:

Publications indexed to this study:

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

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:

RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 14, 2009