Common TitleM98-863
Official Title A Randomized, Double-Blind, Phase III Study of Lopinavir (ABT-378)/Ritonavir Plus Stavudine and Lamivudine vs Nelfinavir Plus Stavudine and Lamivudine in Antiretroviral Naive HIV-Infected Subjects
Phase Phase III
ClinicalTrials.gov NCT00004583
Treatments
Stavudine
, Stavudine
Tradename:ZeritOther Names:d4TClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Lopinavir-Ritonavir
, Lopinavir-Ritonavir
Tradename:KaletraOther Names:LPV-RTVClass:Protease Inhibitors (PI)Nelfinavir
Nelfinavir
Tradename:ViraceptOther Names:NFVClass:Protease Inhibitors (PI)Categories Resistance/Virological FailureTreatment-NaivePharmacologyAdverse Effects
Funding
IndustryAbbott
References
- Kempf DJ, King MS, Bernstein B, et al. Incidence of resistance in a double-blind study comparing lopinavir/ritonavir plus stavudine and lamivudine to nelfinavir plus stavudine and lamivudine. J Infect Dis. 2004;189:51-60.
- King MS, Bernstein BM, Walmsley SL, et al. Baseline HIV-1 RNA level and CD4 cell count predict time to loss of virologic response to nelfinavir, but not lopinavir/ritonavir, in antiretroviral therapy-naive patients. J Infect Dis. 2004;190:280-4.
- Sherman KE, Shire NJ, Cernohous P, et al. Liver injury and changes in hepatitis C Virus (HCV) RNA load associated with protease inhibitor-based antiretroviral therapy for treatment-naive HCV-HIV-coinfected patients: lopinavir-ritonavir versus nelfinavir. Clin Infect Dis. 2005;41:1186-95.
- Walmsley S, Bernstein B, King M, et al. Lopinavir-ritonavir versus nelfinavir for the initial treatment of HIV infection. N Engl J Med. 2002;346:2039-46.