Lopinavir/ritonavir monotherapy after virologic failure of first-line antiretroviral therapy in resource-limited settings.
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 articleSubject
Acquired Immunodeficiency SyndromeAdenine
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
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https://hdl.handle.net/10161/13791Published Version (Please cite this version)
10.1097/QAD.0b013e328353b066Publication 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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Show full item recordScholars@Duke
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
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