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.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.identifier | ||
dc.identifier.eissn | 1473-5571 | |
dc.identifier.uri | ||
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 | |
pubs.author-url | ||
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 |