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dc.contributor.authorJourdain, Gonzagueen_US
dc.contributor.authorLe Cœur, Sophieen_US
dc.contributor.authorNgo-Giang-Huong, Nicoleen_US
dc.contributor.authorTraisathit, Patrineeen_US
dc.contributor.authorCressey, Tim R.en_US
dc.contributor.authorFregonese, Federicaen_US
dc.contributor.authorLeurent, Baptisteen_US
dc.contributor.authorCollins, Intira J.en_US
dc.contributor.authorTechapornroong, Maleeen_US
dc.contributor.authorBanchongkit, Sukiten_US
dc.contributor.authorBuranabanjasatean, Sudaneeen_US
dc.contributor.authorHalue, Guttigaen_US
dc.contributor.authorNilmanat, Ampaipithen_US
dc.contributor.authorLuekamlung, Nuananongen_US
dc.contributor.authorKlinbuayaem, Viraten_US
dc.contributor.authorChutanunta, Apichaten_US
dc.contributor.authorKantipong, Pachareeen_US
dc.contributor.authorBowonwatanuwong, Chureeratanaen_US
dc.contributor.authorLertkoonalak, Ritthaen_US
dc.contributor.authorLeenasirimakul, Prattanaen_US
dc.contributor.authorTansuphasawasdikul, Somboonen_US
dc.contributor.authorSang-a-gad, Pensiriwanen_US
dc.contributor.authorPathipvanich, Panitaen_US
dc.contributor.authorThongbuaban, Srisudaen_US
dc.contributor.authorWittayapraparat, Pakornen_US
dc.contributor.authorEiamsirikit, Nareeen_US
dc.contributor.authorBuranawanitchakorn, Yuwadeeen_US
dc.contributor.authorYutthakasemsunt, Narueponen_US
dc.contributor.authorWiniyakul, Narongen_US
dc.contributor.authorDecker, Lucen_US
dc.contributor.authorBarbier, Sylvaineen_US
dc.contributor.authorKoetsawang, Supornen_US
dc.contributor.authorSirirungsi, Wasnaen_US
dc.contributor.authorMcIntosh, Kennethen_US
dc.contributor.authorThanprasertsuk, Sombaten_US
dc.contributor.authorLallemant, Marcen_US
dc.date.accessioned2014-03-01T02:23:50Z
dc.date.issued2013en_US
dc.identifier.citationJourdain, G., S. Le Cœur, N. Ngo-Giang-Huong, P. Traisathit, T. R. Cressey, F. Fregonese, B. Leurent, et al. 2013. “Switching HIV Treatment in Adults Based on CD4 Count Versus Viral Load Monitoring: A Randomized, Non-Inferiority Trial in Thailand.” PLoS Medicine 10 (8): e1001494. doi:10.1371/journal.pmed.1001494. http://dx.doi.org/10.1371/journal.pmed.1001494.en
dc.identifier.issn1549-1277en
dc.identifier.urihttp://nrs.harvard.edu/urn-3:HUL.InstRepos:11855722
dc.description.abstractBackground: Viral load (VL) is recommended for monitoring the response to highly active antiretroviral therapy (HAART) but is not routinely available in most low- and middle-income countries. The purpose of the study was to determine whether a CD4-based monitoring and switching strategy would provide a similar clinical outcome compared to the standard VL-based strategy in Thailand. Methods and Findings: The Programs for HIV Prevention and Treatment (PHPT-3) non-inferiority randomized clinical trial compared a treatment switching strategy based on CD4-only (CD4) monitoring versus viral-load (VL). Consenting participants were antiretroviral-naïve HIV-infected adults (CD4 count 50–250/mm3) initiating non-nucleotide reverse transcriptase inhibitor (NNRTI)-based therapy. Randomization, stratified by site (21 public hospitals), was performed centrally after enrollment. Clinicians were unaware of the VL values of patients randomized to the CD4 arm. Participants switched to second-line combination with confirmed CD4 decline >30% from peak (within 200 cells from baseline) in the CD4 arm, or confirmed VL >400 copies/ml in the VL arm. Primary endpoint was clinical failure at 3 years, defined as death, new AIDS-defining event, or CD4 <50 cells/mm3. The 3-year Kaplan-Meier cumulative risks of clinical failure were compared for non-inferiority with a margin of 7.4%. In the intent to treat analysis, data were censored at the date of death or at last visit. The secondary endpoints were difference in future-drug-option (FDO) score, a measure of resistance profiles, virologic and immunologic responses, and the safety and tolerance of HAART. 716 participants were randomized, 356 to VL monitoring and 360 to CD4 monitoring. At 3 years, 319 participants (90%) in VL and 326 (91%) in CD4 were alive and on follow-up. The cumulative risk of clinical failure was 8.0% (95% CI 5.6–11.4) in VL versus 7.4% (5.1–10.7) in CD4, and the upper-limit of the one-sided 95% CI of the difference was 3.4%, meeting the pre-determined non-inferiority criterion. Probability of switch for study criteria was 5.2% (3.2–8.4) in VL versus 7.5% (5.0–11.1) in CD4 (p = 0.097). Median time from treatment initiation to switch was 11.7 months (7.7–19.4) in VL and 24.7 months (15.9–35.0) in CD4 (p = 0.001). The median duration of viremia >400 copies/ml at switch was 7.2 months (5.8–8.0) in VL versus 15.8 months (8.5–20.4) in CD4 (p = 0.002). FDO scores were not significantly different at time of switch. No adverse events related to the monitoring strategy were reported. Conclusions: The 3-year rates of clinical failure and loss of treatment options did not differ between strategies although the longer-term consequences of CD4 monitoring would need to be investigated. These results provide reassurance to treatment programs currently based on CD4 monitoring as VL measurement becomes more affordable and feasible in resource-limited settings. Trial registration ClinicalTrials.gov NCT00162682 Please see later in the article for the Editors' Summaryen
dc.language.isoen_USen
dc.publisherPublic Library of Scienceen
dc.relation.isversionofdoi:10.1371/journal.pmed.1001494en
dc.relation.hasversionhttp://www.ncbi.nlm.nih.gov/pmc/articles/PMC3735458/pdf/en
dash.licenseLAAen_US
dc.subjectMedicineen
dc.subjectClinical Research Designen
dc.subjectClinical Trialsen
dc.subjectEpidemiologyen
dc.subjectInfectious Diseasesen
dc.subjectSexually Transmitted Diseasesen
dc.subjectPublic Healthen
dc.titleSwitching HIV Treatment in Adults Based on CD4 Count Versus Viral Load Monitoring: A Randomized, Non-Inferiority Trial in Thailanden
dc.typeJournal Articleen_US
dc.description.versionVersion of Recorden
dc.relation.journalPLoS Medicineen
dash.depositing.authorJourdain, Gonzagueen_US
dc.date.available2014-03-01T02:23:50Z
dc.identifier.doi10.1371/journal.pmed.1001494*
dash.authorsorderedfalse
dash.contributor.affiliatedMcIntosh, Kenneth
dash.contributor.affiliatedLallemant, Marc
dash.contributor.affiliatedJourdain, Gonzague


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