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

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Date
2012-07-17
Authors
Bartlett, John A
Ribaudo, Heather J
Wallis, Carole L
Aga, Evgenia
Katzenstein, David A
Stevens, Wendy S
Norton, Michael R
Klingman, Karin L
Hosseinipour, Mina C
Crump, John A
Supparatpinyo, Khuanchai
Badal-Faesen, Sharlaa
Kallungal, Beatrice A
Kumarasamy, Nagalingeswaran
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(14 total)
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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.
Type
Journal article
Subject
Acquired Immunodeficiency Syndrome
Adenine
Adult
Africa
Anti-HIV Agents
Deoxycytidine
Drug Administration Schedule
Drug Therapy, Combination
Emtricitabine
Female
Health Resources
Humans
India
Lopinavir
Male
Medication Adherence
Middle Aged
Mutation
Organophosphonates
Patient Selection
Pilot Projects
RNA, Viral
Reverse Transcriptase Inhibitors
Ritonavir
Surveys and Questionnaires
Tenofovir
Thailand
Treatment Failure
Viral Load
Permalink
https://hdl.handle.net/10161/13791
Published Version (Please cite this version)
10.1097/QAD.0b013e328353b066
Publication Info
Bartlett, John A; Ribaudo, Heather J; Wallis, Carole L; Aga, Evgenia; Katzenstein, David A; Stevens, Wendy S; ... Kumarasamy, Nagalingeswaran (2012). Lopinavir/ritonavir monotherapy after virologic failure of first-line antiretroviral therapy in resource-limited settings. AIDS, 26(11). pp. 1345-1354. 10.1097/QAD.0b013e328353b066. Retrieved from https://hdl.handle.net/10161/13791.
This is constructed from limited available data and may be imprecise. To cite this article, please review & use the official citation provided by the journal.
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Scholars@Duke

Bartlett

John Alexander Bartlett

Professor of Medicine
My clinical investigation is focused on the pathogenesis and treatment of HIV infection and its complicastions, especially in resource-limited settings. Key Words: HIV infection, AIDS, treatment strategies, treatment failure, co-infections, resource-limited settings

John Andrew Crump

Adjunct Professor in the Department of Medicine
I am based in northern Tanzania where I am Site Leader for Duke University’s collaborative research program based at Kilimanjaro Christian Medical Centre and Director of Tanzania Operations for the Duke Global Health Institute. I oversee the design and implementation of research studies on infectious diseases, particularly febrile illness, invasive bacterial disease, HIV-associated opportunistic infections, clinical trials of antiretroviral therapy and prevention of mother-to-child tr
Alphabetical list of authors with Scholars@Duke profiles.
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