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Examination of noninferiority, safety, and tolerability of lopinavir/ritonavir and raltegravir compared with lopinavir/ritonavir and tenofovir/ emtricitabine in antiretroviral-naïve subjects: the progress study, 48-week results.

TitleExamination of noninferiority, safety, and tolerability of lopinavir/ritonavir and raltegravir compared with lopinavir/ritonavir and tenofovir/ emtricitabine in antiretroviral-naïve subjects: the progress study, 48-week results.
Publication TypeJournal Article
Year of Publication2011
AuthorsReynes J, Lawal A, Pulido F, Soto-Malave R, Gathe J, Tian M, Fredrick LM, Podsadecki TJ, Nilius AM
JournalHIV Clin Trials
Volume12
Issue5
Pagination255-67
Date Published2011 Sep-Oct
ISSN1528-4336
KeywordsAdenine, Adult, Algorithms, Anti-HIV Agents, Antiretroviral Therapy, Highly Active, Deoxycytidine, Drug Administration Schedule, Drug Therapy, Combination, Emtricitabine, Female, HIV Infections, HIV Integrase Inhibitors, HIV Protease Inhibitors, HIV-1, Humans, Lopinavir, Male, Middle Aged, Organophosphonates, Pyrrolidinones, Raltegravir Potassium, Reverse Transcriptase Inhibitors, Ritonavir, RNA, Viral, Tenofovir, Treatment Outcome, United States, United States Food and Drug Administration, Viral Load
Abstract

PURPOSE: Current antiretroviral regimens recommended for treatment-naïve patients include 2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs). The purpose of this study is to evaluate whether a new NRTI-sparing regimen may provide an alternative for persons for whom traditional regimens may not be the best option.

METHODS: PROGRESS is a 96-week, randomized, open-label, multicenter trial comparing the efficacy and safety of a boosted protease inhibitor (PI) and an integrase inhibitor (lopi-navir/ritonavir [LPV/r] + raltegravir [RAL]) to a boosted PI and 2 NRTIs (LPV/r + tenofovir/ emtricitabine [TDF/FTC]) in antiretroviral (ARV)-naïve HIV-1-infected adults.

RESULTS: A total of 206 subjects were randomized to receive LPV/r + RAL (n=101) or LPV/r + TDF/FTC (n=105) and analyzed for ARV efficacy using the US Food and Drug Administration time to loss of virologic response (FDA-TLOVR) algorithm. The percentage of subjects with plasma HIV-1 RNA <40 copies/mL at week 48 was 83.2% in the LPV/r + RAL group and 84.8% in the LPV/r + TDF/FTC group (P = .850; difference -1.6%; exact 95% CI, -12.0% to 8.8%). As the lower limit of the exact 95% CI for the difference between regimens was at or above the protocol-defined threshold of -20% (as well as the more stringent threshold of -12%), LPV/r + RAL was noninferior to LPV/r + TDF/FTC. The occurrence of treatment-related, moderate/severe adverse events was similar between treatment groups through 48 weeks of treatment.

CONCLUSIONS: The HIV treatment regimen of LPV/r + RAL resulted in noninferior efficacy and comparable safety and tolerability compared with a traditional NRTI-containing regimen through 48 weeks of treatment. These results support further evaluation of the LPV/r + RAL regimen.

DOI10.1310/hct1205-255
Alternate JournalHIV Clin Trials
PubMed ID22180523