Last updated on February 2015

Test Albuvirtide in Experienced Patients


Brief description of study

The purpose of this study is to determine the efficacy and safety of albuvirtide plus lopinavir-ritonavir in HIV-1-infected adults who failed first-line antiretroviral therapy.

Detailed Study Description

This is a 48-week, randomized, controlled, open-label, multicenter study of the safety and efficacy of albuvirtide plus lopinavir-ritonavir in HIV-1 infected adults who are failing their first antiretroviral regimen and have HIV-1 RNA levels >= 1000 copies/mL at screening. Subjects meeting inclusion criteria are randomized in a 1:1 ratio to receive either albuvirtide + lopinavir-ritonavir or lopinavir-ritonavir + TDF + 3TC. If TDF is used in the current regimen or genotypic resistance test shows primary mutation to TDF, zidovudine (AZT) or abacavir will be used. Albuvirtide will be given by weekly intravenous infusion and LPV/r will be given twice daily. The primary end point is the percentage of participants with HIV-1 RNA<50 copies/mL at Week 48, the secondary end points include the change of HIV-1 RNA from baseline through Week 48, the percentage of participants with HIV-1 RNA<400 copies/mL at Week 48, and the change of CD4 count from baseline through Week 48.

Clinical Study Identifier: NCT02369965

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