drugset / Trial / NCT01605084

Second-line Treatment of HIV-1 With Ritonavir Boosted Atazanavir or Darunavir With an Optimized NRTI Backbone

NCT01605084

Phase 3 Withdrawn Bristol-Myers Squibb
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to determine the proportion of subjects with HIV-1 RNA \< 50 c/mL at Week 48 in patients who failed their first line therapy containing a non-nucleoside reverse transcriptase inhibitor (NNRTI) or an integrase inhibitor

Timeline

Start
2012-06-30
Primary completion
2014-08-31
Completion
2014-08-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Atazanavir Other / unclassified 300 mg Oral
Subject Darunavir Small molecule 800 mg Oral
Background Abacavir Other / unclassified 300 mg
Background Abacavir Other / unclassified 600 mg
Background Didanosine Small molecule 250 mg
Background Didanosine Small molecule 400 mg
Background Lamivudine Other / unclassified 150 mg
Background Lamivudine Other / unclassified 300 mg
Background Ritonavir Other / unclassified 100 mg Oral
Background Stavudine Other / unclassified 30 mg
Background Stavudine Other / unclassified 40 mg
Background Tenofovir Small molecule 300 mg
Background Zidovudine Small molecule 300 mg
Background emtricitabine Other / unclassified 200 mg