DRIVESHAFT: Darunavir/Ritonavir In HIV-infected Virologically-suppressed Experienced Subjects (DRIVESHAFT)
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ClinicalTrials.gov Identifier: NCT01423812
Recruitment Status :
First Posted : August 26, 2011
Results First Posted : February 7, 2018
Last Update Posted : February 7, 2018
Ruth M. Rothstein CORE Center
Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
The sample size was not adequately powered to evaluate non-inferiority, which might be clinically relevant. As a single-center study, identifying an appropriate number of eligible patients to determine non-inferiority was not feasible.
1. De Meyer S, et al. Antiviral activity of TMC 114, a potent next generation protease inhibitor against more than 4000 recent recombinant clinical isolates exhibiting a wide range of protease inhibitor resistance profile. Antiviral Ther 2003;8:3S19. 2. De Meyer S, et al. In vitro selection experiments demonstrate an increased genetic barrier to resistance development to TMC 114 as compared with currently licensed protease inhibitors. Antiviral Ther 2002;7(Suppl 1):S5. 3. De Meyer SD, et al. Phenotypic and genotypic determinants of resistance to TMC 114: pooled analysis of POWER 1,2, and 3. Antiviral Ther 2006;11:S83. 4. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services. December 1,2009;1-161. Available at http://www.aidsinfo.nih.gov/ContentFiles/Adultand AdolescentGL.pdf. Accessed September 15, 2010. 5. Clotet B, et al. Efficacy and Safety of Darunavir/ritonavir at week 48 in treatment-experienced patients with HIV-1 infection in POWER 1 and 2: A Pooled Subgroup Analysis of Data from Two Randomized Trials. The Lancet 2007;369:1169-78. 6. Cahn PK, et al. Efficacy and Safety at 48 Weeks of Once-daily vs Twice-daily DRV.r in Treatment-experienced HIV-1-positive Patients with No DRV Resistance-associated Mutations: The ODIN Trial. Abstract 57. 17th Conference on Retroviruses and Opportunistic Infections (CROI 2010). San Francisco. February 16-19, 2010. 7. Moltó J, et al. Treatment simplification to once daily darunavir/ritonavir guided by the darunavir inhibitory quotient in heavily pretreated HIV-infected patients. Antivir Ther. 2010;15(2):219-25. 8. Paterson DL, et al. Adherence to protease inhibitor therapy and outcomes in patients with HIV infection. Ann Intern Med 2000;133:21-30.
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