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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 Optimi...

Update Il y a 5 ans
Reference: EUCTR2005-005127-34

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 HIVInfected Patients With Documented Resistance to at Least 1 Drug in Each of the 3 Classes of Licensed Oral Antiretroviral Therapies

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Extract

In HIV-infected patients failing therapy, with HIV RNA >1000 copies/mL and documented resistance to at least 1 drug in each of the 3 classes of licensed oral antiretrovirals (ARTs) (Nucleoside Reverse Transcriptase Inhibitors [NRTIs], Non-Nucleoside Reverse Transcriptase Inhibitors [NNRTIs], and Protease Inhibitors [PIs]): (1) Evaluate the antiretroviral activity of MK-0518 400 mg b.i.d. compared to placebo, both in combination with Optimized Background Therapy (OBT), as measured by proportion of patients achieving HIV RNA <400 copies/mL at Week 16. (2) Evaluate the safety and tolerability of MK-0518 400 mg b.i.d. compared to placebo, both in combination with OBT, assessed by review of the accumulated safety data.

Inclusion criteria

  • Unspecified human immuno-deficiency virus [HIV] disease

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