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Merck Integrase Study for Patients with HIV Drug Resistance
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Here is link to the Merck website where you can find study sites listed along with additional information about the study:
http://www.benchmrk.com/secure/investigator_sites/sites.html
Any day now Merck will announce the opening of a website containing information about this study. There is also a tel# below. The entry criteria for this study is liberal and its an opportunity to access a new new class of drug, integrase inhibitors, if you have extensive HIV drug resistance & need a new regimen. You should consult with your doctor about whether the study is appropriate for you. Eventually, perhaps at the end of 2006, an Expanded Access Program is expected.
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 February 2006 Sponsored by: Merck
Information provided by: Merck
Purpose: This study will investigate the safety and efficacy of MK-0518 as a therapy for HIV-infected patients failing current therapy.
Phase III
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
Eligibility Ages Eligible for Study: 16 Years and above, Genders Eligible for Study: Both
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.
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00293254
Toll Free Number 1-888-577-8839
District of Columbia
Call for Information, Washington, District of Columbia, 20009-0000, United States; Recruiting
Florida
Call for Information, Vero Beach, Florida, 32960, United States; Recruiting
Call for Information, Fort Lauderdale, Florida, 33308, United States; Recruiting
New York
Call for Information, Albany, New York, 12208-0000, United States; Recruiting
Call for Information, Rochester, New York, 14642-0000, United States; Recruiting
Oregon
Call for Information, Portland, Oregon, 97219-0000, United States; Recruiting
Texas
Call for Information, Austin, Texas, 78705, United States; Recruiting
Brazil, SP
Merck Sharp & Dohme Farmaceutica Ltda., Sao Paulo, SP, 04717-004, Brazil; Not yet Recruiting
Jose Octavio P. Costa Filo 55-11-5189-7700
Canada, Quebec
Merck Frosst Canada Ltd., Kirkland, Quebec, H9H 3L1, Canada; Not yet Recruiting
Francois Bertrand, Dr. 1-514-428-2641
Colombia, Cundinamarca
Frosst Laboratories Inc., Bogota, Cundinamarca, Colombia; Not yet Recruiting
Ernesto Aycardi, Dr. 571-219-1099
Mexico, D.F.
Merck Sharp & Dohme De Mexico, S.A. De C.V., Mexico, D.F., 1090, Mexico; Not yet Recruiting
Jorge Vinces, Dr. +511-411-5933/52 55 5481 9532
Study chairs or principal investigators
Medical Monitor, Study Director, Merck
Last Updated: February 16, 2006
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