2026-06-08T12:22:20Zhttps://docta.ucm.es/rest/oai/requestoai:docta.ucm.es:20.500.14352/1073042025-09-01T17:31:16Zcom_20.500.14352_14col_20.500.14352_15
Docta Complutense
author
Pulido Ortega, Federico
author
Rubio García, Rafael
author
Norton, Michael
2024-07-31T11:09:30Z
2024-07-31T11:09:30Z
2008
Pulido F, Arribas JR, Delgado R, Cabrero E, González-García J, Pérez-Elias MJ, Arranz A, Portilla J, Pasquau J, Iribarren JA, Rubio R, Norton M; OK04 Study Group. Lopinavir-ritonavir monotherapy versus lopinavir-ritonavir and two nucleosides for maintenance therapy of HIV. AIDS. 2008 Jan 11;22(2):F1-9
0269-9370
10.1097/QAD.0b013e3282f4243b
https://hdl.handle.net/20.500.14352/107304
https://doi.org/10.1097/QAD.0b013e3282f4243b
18097218
https://journals.lww.com/aidsonline/abstract/2008/01110/lopinavir_ritonavir_monotherapy_versus.1.aspx
Background: Prior attempts to reduce the number of drugs needed to maintain viral suppression in patients with suppressed HIV replication while receiving three antiretroviral drugs have been unsuccessful.
Methods: In 205 patients with suppressed HIV replication on lopinavir-ritonavir and two nucleosides, this randomized, open-label, non-inferiority clinical trial compared the strategies of continuation of triple therapy versus lopinavir-ritonavir monotherapy followed by reinduction with two nucleosides if virological rebound occurred without genotypic resistance to lopinavir-ritonavir. The primary endpoint was proportion of patients without therapeutic failure, defined as confirmed HIV RNA higher than 500 copies/mL (with exclusion of patients receiving monotherapy who resuppressed to < 50 copies/mL after resuming baseline nucleosides), or loss to follow-up, or change of randomized therapy other than reinduction.
Results: At week 48, the percentage of patients without therapeutic failure was 94% in the monotherapy group versus 90% in the triple therapy group (difference,-4%; upper limit of 95% confidence interval for difference, 3.4%). The percentage of patients with HIV RNA 50 copies/mL at 48 weeks by intention-to-treat, missing data or reinductions considered as failures, were 85% in the monotherapy group versus 90% in the triple therapy group (P = 0.31; 95% upper limit of 95% confidence interval for difference, 14%).
Conclusion: In this trial, 48 weeks of lopinavir-ritonavir monotherapy with reintroduction of nucleosides as needed was non-inferior to continuation of two nucleosides and lopinavir-ritonavir in patients with prior stable suppression. However, episodes of low level viremia were more common in patients receiving monotherapy.
eng
Lopinavir-ritonavir monotherapy versus lopinavir-ritonavir and two nucleosides for maintenance therapy of HIV
journal article
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URL
https://docta.ucm.es/bitstreams/63012422-9f1d-46d6-a264-87d437ba2cd2/download
File
MD5
ad2fddda7c6cf04cb1f080708aea8878
146868
application/pdf
2008. AIDS. OK-Pulido.pdf