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An Open-Label, Randomized Study Evaluating a Switch from a Regimen of Two Nucleoside Reverse Transcriptase Inhibitors plus any Third Agent to either a Regimen of Atazanavir/Ritonavir Once Daily and Ra...

Update Il y a 5 ans
Reference: EUCTR2009-017032-41

An Open-Label, Randomized Study Evaluating a Switch from a Regimen of Two Nucleoside Reverse Transcriptase Inhibitors plus any Third Agent to either a Regimen of Atazanavir/Ritonavir Once Daily and Raltegravir Twice Daily or to a Regimen of Atazanavir/Ritonavir Once Daily and Tenofovir/Emtricitabine Once Daily in Virologically Suppressed HIV-1 Infected Subjects With Safety and/or Tolerability Issues on their Present Treatment Regimen (the HARNESS study)

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Extract

The primary objective of this study is to estimate the proportion of subjects with HIV 1 RNA < 40 c/mL through 24 weeks, following a switch due to treatment related safety and/or tolerability issues, from a regimen consisting of 2 NRTI + any 3rd agent, to a regimen consisting of ATV/RTVHS 300/100mg QD + RAL 400 mg BID

Inclusion criteria

  • HIV-1 infected subjects who are virologically suppressed on a regimen of 2 NRTIs plus any 3rd agent, but experience safety and/or tolerability issues to this regimen

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