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Lopinavir/ritonavir monotherapy after virologic failure of first-line antiretroviral therapy in resource-limited settings.

dc.contributor.author Bartlett, John A
dc.contributor.author Ribaudo, Heather J
dc.contributor.author Wallis, Carole L
dc.contributor.author Aga, Evgenia
dc.contributor.author Katzenstein, David A
dc.contributor.author Stevens, Wendy S
dc.contributor.author Norton, Michael R
dc.contributor.author Klingman, Karin L
dc.contributor.author Hosseinipour, Mina C
dc.contributor.author Crump, John A
dc.contributor.author Supparatpinyo, Khuanchai
dc.contributor.author Badal-Faesen, Sharlaa
dc.contributor.author Kallungal, Beatrice A
dc.contributor.author Kumarasamy, Nagalingeswaran
dc.coverage.spatial England
dc.date.accessioned 2017-03-02T19:21:47Z
dc.date.available 2017-03-02T19:21:47Z
dc.date.issued 2012-07-17
dc.identifier https://www.ncbi.nlm.nih.gov/pubmed/22441252
dc.identifier.uri https://hdl.handle.net/10161/13791
dc.description.abstract OBJECTIVE: To evaluate virologic response rates of lopinavir/ritonavir (LPV/r) monotherapy as second-line antiretroviral treatment (ART) among adults in resource-limited settings (RLSs). DESIGN: An open-label pilot study of LPV/r monotherapy in participants on first-line nonnucleoside reverse transcriptase inhibitor three-drug combination ART with plasma HIV-1 RNA 1000-200 000  copies/ml. METHODS: Participants were recruited from five sites in Africa and Asia within the AIDS Clinical Trials Group (ACTG) network. All participants received LPV/r 400/100  mg twice daily. The primary endpoint was remaining on LPV/r monotherapy without virologic failure at week 24. Participants with virologic failure were offered addition of emtricitabine and tenofovir (FTC/TDF) to LPV/r. RESULTS: Mutations associated with drug resistance were encountered in nearly all individuals screened for the study. One hundred and twenty-three participants were enrolled, and 122 completed 24 weeks on study. A high proportion remained on LPV/r monotherapy without virologic failure at 24 weeks (87%). Archived samples with HIV-1 RNA levels less than 400  copies/ml at week 24 (n=102) underwent ultrasensitive assay. Of these individuals, 62 had levels less than 40  copies/ml and 30 had levels 40-200  copies/ml. Fifteen individuals experienced virologic failure, among whom 11 had resistance assessed and two had emergent protease inhibitor mutations. Thirteen individuals with virologic failure added FTC/TDF and one individual added FTC/TDF without virologic failure. At study week 48, 11 of 14 adding FTC/TDF had HIV-1 RNA levels less than 400  copies/ml. CONCLUSION: In this pilot study conducted in diverse RLS, LPV/r monotherapy as second-line ART demonstrated promising activity.
dc.language eng
dc.publisher Ovid Technologies (Wolters Kluwer Health)
dc.relation.ispartof AIDS
dc.relation.isversionof 10.1097/QAD.0b013e328353b066
dc.subject Acquired Immunodeficiency Syndrome
dc.subject Adenine
dc.subject Adult
dc.subject Africa
dc.subject Anti-HIV Agents
dc.subject Deoxycytidine
dc.subject Drug Administration Schedule
dc.subject Drug Therapy, Combination
dc.subject Emtricitabine
dc.subject Female
dc.subject Health Resources
dc.subject Humans
dc.subject India
dc.subject Lopinavir
dc.subject Male
dc.subject Medication Adherence
dc.subject Middle Aged
dc.subject Mutation
dc.subject Organophosphonates
dc.subject Patient Selection
dc.subject Pilot Projects
dc.subject RNA, Viral
dc.subject Reverse Transcriptase Inhibitors
dc.subject Ritonavir
dc.subject Surveys and Questionnaires
dc.subject Tenofovir
dc.subject Thailand
dc.subject Treatment Failure
dc.subject Viral Load
dc.title Lopinavir/ritonavir monotherapy after virologic failure of first-line antiretroviral therapy in resource-limited settings.
dc.type Journal article
duke.contributor.id Bartlett, John A|0058484
duke.contributor.id Crump, John A|0231646
pubs.author-url https://www.ncbi.nlm.nih.gov/pubmed/22441252
pubs.begin-page 1345
pubs.end-page 1354
pubs.issue 11
pubs.organisational-group Clinical Science Departments
pubs.organisational-group Duke
pubs.organisational-group Duke Cancer Institute
pubs.organisational-group Duke Science & Society
pubs.organisational-group Global Health Institute
pubs.organisational-group Initiatives
pubs.organisational-group Institutes and Centers
pubs.organisational-group Institutes and Provost's Academic Units
pubs.organisational-group Medicine
pubs.organisational-group Medicine, Infectious Diseases
pubs.organisational-group Pathology
pubs.organisational-group School of Medicine
pubs.organisational-group School of Nursing
pubs.organisational-group School of Nursing - Secondary Group
pubs.organisational-group University Institutes and Centers
pubs.publication-status Published
pubs.volume 26
dc.identifier.eissn 1473-5571


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