quarta-feira, julho 26, 2006

Merck recruta para ensaio com novo inibidor de integrase

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


This study is currently recruiting patients.
Verified by Merck May 2006
Sponsored by: Merck
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.

Drug: MK0518 / Duration of Treatment - 48 Weeks
Drug: Placebo & Optimized Antiretroviral Background Therapy / Duration of Treatment - 48 Weeks

Phase III
MedlinePlus related topics: AIDS
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, 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 Outcomes: Proportion of patients achieving HIV RNA <400 copies/mL at Weeks 24; safety and tolerability assessed by review of the accumulated safety data. Secondary Outcomes: 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.

Expected Total Enrollment: 345
Study start: February 2006

Ages Eligible for Study: 16 Years and above, Genders Eligible for Study: Both

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.

Location and Contact Information:
Merck Sharp & Dohme Lda, Paco D'arcos, 2770-192, Portugal; Recruiting
Isabel Boaventura 351.21.446.5821

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