Phase IIB Pilot of Atazanavir + Raltegravir

Phase 2 Terminated 167 enrolled Bristol-Myers Squibb Merck Sharp & Dohme LLC · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to determine if the combination of atazanavir and raltegravir taken together is safe and effective in the treatment of human immunodeficiency virus (HIV).

Timeline

Start: 2008-11
Primary completion: 2010-01
Completion: 2010-05

Outcome

Outcome not reported

Stopped: “Efficacy endpoint met, but overall experimental dosing regimen not considered optimal to support further clinical development in this population.”

Publications

Kozal MJ, Lupo S, DeJesus E, Molina JM, McDonald C, Raffi F, Benetucci J, Mancini M, Yang R, Wirtz V, Percival L, Zhang J, Zhu L, Arikan D, Farajallah A, Nguyen BY, Leavitt R, McGrath D, Lataillade M, The Spartan Study Team. A nucleoside- and ritonavir-sparing regimen containing atazanavir plus raltegravir in antiretroviral treatment-naive HIV-infected patients: SPARTAN study results. HIV Clin Trials. 2012 May-Jun;13(3):119-30. doi: 10.1310/hct1303-119.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Atazanavir	Other / unclassified	300 mg	Oral
Subject	Raltegravir	Other / unclassified	400 mg	Oral
Comparator	Ritonavir	Other / unclassified	100 mg	Oral
Comparator	Tenofovir	Small molecule	300 mg	Oral
Comparator	emtricitabine	Other / unclassified	200 mg	Oral