MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY AND ANTIRETROVIRAL ACTIVITY OF MK-0518 IN COMBINATION WITH OPTIMIZED BACKGROUND THERAPY (OBT), VERSUS OPTIMIZED BACKGROUND THERAPY ONLY IN PATIENTS INFECTED WITH HIV WITH DOCUMENTED RESISTANCE A AT LEAST 1 DRUG OF EACH OF THE 3 CLASSES OF AUTHORIZED ORAL ANTIRETROVIRAL THERAPIES

MERCK SHARP & DOHME PERU S.R.L.,0 个研究点目标入组 0 人开始时间: 2006年4月11日最近更新: 2023年9月4日

适应症

试验速览

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•1. The patient is a man or woman 16 years of age or older.
•2. The patient has HIV RNA in plasma at the selection> 1000 copies / mL within 60 days prior to the treatment phase of this study.
•3. The patient has been treated with ART and has had stable treatment with ART for months.
•4. The patient has HIV with documented reduced susceptibility to at least one drug from each of the 3 authorized oral ART classes.
•5. The patient had acceptable laboratory values within 35 days prior to the treatment phase of this study.
•6. The patient has a chest x-ray without signs of active lung disease within 60 days prior to treatment in this study.
•7. The patient with reproductive potential agrees to use an acceptable method of birth control throughout the study. Or The patient has no reproductive potential.

•1. Does not meet the inclusion criteria for the protocol.
•2. The female patient is pregnant or nursing, or is waiting to conceive or donate their eggs during the study. The male patient is planning to fertilize or donate his sperm during the study.
•3. The patient has used any agent under investigation within the month prior to treatment.
•4. The patient has used another experimental HIV integrase inhibitor.
•5. The patient has used an immunosuppressive therapy within the month prior to treatment in this study.
•6. The patient requires or is expected to require any of the prohibited medications listed in the protocol.
•7. The patient has a current (active) diagnosis of acute hepatitis or chronic hepatitis that is not a stable chronic Hepatitis B and / or C.
•8. The patient has a history of abuse of alcohol or other substance that could interfere with the patient´s compliance or safety.
•9. The patient has any laboratory disorder or anomaly prior to the study, or a history of any disease, which could confuse the results of the study or pose an additional risk when administering the study drugs to the patient.
•10. There is an inability to obtain a signed informed consent from a patient 18 years of age or older or when the parent / legal representative has granted consent and there is an inability to obtain the consent of the patient 16 or 17 years of age.

发起方

MERCK SHARP & DOHME PERU S.R.L.,