FrancophonIA/ELRC3.0 huggingface dataset:
English: Of the 7 subjects who developed high level doravirine resistance in the pivotal studies, 6 had phenotypic resistance to EFV and nevirapine, 3 to rilpivirine, and 2 had partial resistance to etravirine based on the Monogram Phenosense assay.
Danish: Af de 7 forsøgspersoner, der udviklede en høj grad af resistens over for doravirin i de pivotale studier, havde 6 fænotypisk resistens over for EFV og nevirapin og 3 over for rilpivirin, og 2 havde delvis resistens over for etravirin på baggrund af Monogram Phenosense-analysen.
English: Therefore, caution should be used when co-administering doravirine with medicinal products that are sensitive CYP3A substrates that also have a narrow therapeutic window (e.g., tacrolimus and sirolimus).
Danish: Derfor skal der udvises forsigtighed, når doravirin administreres sammen med lægemidler, der er følsomme CYP3A-substrater, og som også har et smalt terapeutisk vindue (f.eks. tacrolimus og sirolimus).
English: There is not sufficient clinical evidence to support the use of doravirine in patients infected with HIV-1 with evidence of resistance to the NNRTI class.
Danish: Der er ikke tilstrækkelig klinisk evidens til at understøtte brugen af doravirin hos hiv-1-inficerede patienter med tegn på resistens over for NNRTI-klassen.
English: Treatment emergent doravirine resistance associated substitutions may confer cross-resistance to efavirenz, rilpivirine, nevirapine, and etravirine.
Danish: Behandlingsrelaterede substitutioner associeret med resistens over for doravirin kan give krydsresistens over for efavirenz, rilpivirin, nevirapin og etravirin.
English: Doravirine is primarily metabolised and eliminated by the liver.
Danish: Doravirin metaboliseres og elimineres primært via leveren.
English: Doravirine exhibited an EC50 value of 12.0±4.4 nM against wild-type laboratory strains of HIV-1 when tested in the presence of 100 % normal human serum using MT4-GFP reporter cells.
Danish: Doravirin havde en EC50-værdi på 12,0±4,4 nM mod vildtype-laboratoriestammer af hiv-1, når det blev testet under tilstedeværelse af 100% normalt humant serum ved brug af MT4-GFP-reporterceller.
English: Approximately 70-80 % of the intravenous dose of tenofovir is recovered as unchanged medicinal product in the urine within 72 hours of dosing.
Danish: Ca. 70-80% af den intravenøse dosis tenofovir genvindes som uomdannet lægemiddel i urinen inden for 72 timer efter dosering.
English: Tenofovir is eliminated by a combination of glomerular filtration and active tubular secretion with a renal clearance in adults with CrCl greater than 80 mL per minute of 243.5 ± 33.3 mL per minute (mean ± SD).
Danish: Tenofovir elimineres ved en kombination af glomerulær filtrering og aktiv tubulær sekretion med en renal clearance hos voksne med en CrCl større end 80 ml pr. minut på 243,5 ± 33,3 ml pr. minut (gennemsnit ± SD).
English: The highest frequency category reported in the 3TC or TDF Summary of Product Characteristics is used.
Danish: Den højeste bivirkningskategori, der er rapporteret i produktresuméerne for 3TC eller TDF, er anvendt.
English: The oral bioavailability of tenofovir from tenofovir disoproxil in fasted subjects is approximately 25 %.
Danish: Den orale biotilgængelighed af tenofovir fra tenofovirdisoproxil hos fastende forsøgspersoner er ca. 25%.
English: Uncommon pruritus
Danish: Ikke almindelig pruritus
English: • Do not take two doses of Delstrigo at the same time to make up for a missed dose.
Danish: • Du må ikke tage en dobbeltdosis af Delstrigo som erstatning for den glemte dosis.
English: To monitor maternal-foetal outcomes in patients exposed to antiretroviral medicinal products while pregnant, an Antiretroviral Pregnancy Registry has been established.
Danish: Register over anvendelse af antiretroviral behandling under graviditet Med henblik på at monitorere maternelle-føtale udfald hos patienter, der er blevet eksponeret for antiretrovirale lægemidler under graviditeten, er der oprettet et register over anvendelse af antiretroviral behandling under graviditet.
English: Includes subjects who discontinued study drug or study before Week 48 for ISG or before Week 24 for DSG for lack or loss of efficacy and subjects with HIV-1 RNA ≥ 40 copies/mL in the Week 48 window for ISG and in the Week 24 window for DSG.
Danish: Inkluderer forsøgspersoner som ophørte med studiemedicinen eller udtrådte af studiet før uge 48 for ISG eller før uge 24 for DSG på grund af mangel på eller tab af virkning og forsøgspersoner med hiv-1 RNA ≥ 40 kopier/ml i uge 48-vinduet for ISG og i uge 24-vinduet for DSG.
English: A panel of 96 diverse clinical isolates containing NNRTI-associated mutations was evaluated for susceptibility to doravirine in the presence of 10 % foetal bovine serum.
Danish: Et panel af 96 forskelligartede kliniske isolater, der havde NNRTI-associerede mutationer, blev vurderet for følsomhed over for doravirin under tilstedeværelsen af 10% føtalt okseserum.
English: The DRIVE-SHIFT study included virologically suppressed patients (N=670) with no history of treatment failure (see section, Clinical experience).
Danish: DRIVE-SHIFT-studiet inkluderede virologisk supprimerede patienter (N=670) uden behandlingssvigt i anamnesen (se afsnittet Klinisk erfaring).
English: The EC50 values for tenofovir were in the range of 0.04-8.5 microM.
Danish: værdierne for tenofovir lå i intervallet 0,04-8,5 µM.
English: Lamivudine was not teratogenic in animal studies but there were indications of an increase in early embryonic deaths in rabbits at relatively low systemic exposures, comparable to those achieved in humans.
Danish: Lamivudin var ikke teratogent i dyreforsøg, men der var tegn på en stigning i antallet af dødsfald i det tidlige fosterstadium hos kaniner ved relativt lave systemiske eksponeringer sammenlignet med de eksponeringer, der nås hos mennesker.
English: You may require blood tests for several months after stopping treatment.
Danish: Det kan være nødvendigt, at du får taget blodprøver, i flere måneder efter at du er stoppet med behandlingen.
English: Following a single 245 mg dose of tenofovir disoproxil, a 4-hour hemodialysis session removed approximately 10 % of the administered tenofovir dose.
Danish: Efter en enkelt 245 mg dosis tenofovirdisoproxil fjernede en hæmodialyse-session på 4 timer ca. 10% af den administrerede tenofovir-dosis.
English: Use with CYP3A inducers
Danish: Brug sammen med CYP3A-induktorer
English: See “Other medicines and Delstrigo” section for a list of medicines.
Danish: Se punktet “Brug af anden medicin sammen med Delstrigo” for en liste over lægemidler.
English: Based on more than 200 mother/child pairs treated for HIV, serum concentrations of lamivudine in breast-fed infants of mothers treated for HIV are very low (< 4 % of maternal serum concentrations) and progressively decrease to undetectable levels when breast-fed infants reach 24 weeks of age.
Danish: På baggrund af flere end 200 mor/barn-par, der blev behandlet mod hiv, er serumkoncentrationen af lamivudin hos spædbørn, ammet af mødre i behandling mod hiv, meget lav (< 4% af serumkoncentrationen hos moderen) og falder gradvist til et ikke-detekterbart niveau, når de ammede spædbørn når en alder af 24 uger.
English: Your doctor may check your blood levels or monitor for side effects if you take the following medicines with Delstrigo:
Danish: Det kan være nødvendigt for lægen at kontrollere medicinindholdet i blodet eller holde øje med, om du får bivirkninger, hvis du tager følgende lægemidler sammen med Delstrigo:
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Delstrigo in one or more subsets of the paediatric population in treatment of human immunodeficiency virus-1 (HIV-1) infection, as per Paediatric Investigation Plans (PIP) decision in the granted indication.
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Delstrigo i en eller flere undergrupper af den pædiatriske population ved behandling af humant immundefektvirus-1 (hiv-1)-infektion i henhold til afgørelsen i det Pædiatriske Forsknings- og Udviklingsprogram (PIP) (se pkt.
English: Blood tests may also show: • increased levels in liver enzymes (ALT)
Danish: Blodprøver kan også vise: • øget indhold af leverenzymer (ALAT)
English: Doravirine is primarily eliminated via oxidative metabolism mediated by CYP3A4.
Danish: Doravirin elimineres primært via oxidativ metabolisering medieret af CYP3A4.
English: • increased levels of lipase
Danish: • forhøjet indhold af lipase
English: Table 4: Efficacy response (< 40 copies/mL, Snapshot approach) in the pivotal studies
Danish: Tabel 4: Virkningsrespons (< 40 kopier/ml, Snapshot-metode) i pivotale studier
English: Doravirine 100 mg once daily
Danish: Doravirin 100 mg en gang dagligt
English: Immunosuppressants tacrolimus sirolimus
Danish: Immunsuppressiva tacrolimus sirolimus
English: Serum parathyroid hormone levels and 1,25 Vitamin D levels were also higher in subjects receiving tenofovir disoproxil.
Danish: Serumniveauerne af parathyroideahormon og 1,25 vitamin D var også højere hos forsøgspersoner, der fik tenofovirdisoproxil.
English: Administration of doravirine in animal toxicity studies was not associated with toxicity.
Danish: Doravirin Administration af doravirin i toksicitetsstudier hos dyr var ikke forbundet med toksicitet.
English: In other studies (prospective and cross-sectional), the most pronounced decreases in BMD were seen in patients treated with tenofovir disoproxil as part of a regimen containing a boosted protease inhibitor.
Danish: I andre studier (prospektive studier og tværsnitsstudier) blev de mest udtalte fald i BMD set hos patienter, der blev behandlet med tenofovirdisoproxil som del af et regime, der indeholdt en boostet proteasehæmmer.
English: Week 48 outcome (< 40 copies/mL) by baseline factors
Danish: Resultat i uge 48 (< 40 kopier/ml) efter baseline-faktorer
English: Miscellaneous sorbitol solution (3.2 g, 10.2 g, 13.4 g)/lamivudine
Danish: Andet sorbitolopløsning (3,2 g; 10,2 g; 13,4 g)/lamivudin
English: At baseline, the median age of subjects was 43 years, 16 % were female, and 24 % were nonwhite.
Danish: Ved baseline var forsøgspersonernes gennemsnitsalder 43 år, 16% var kvinder og 24% var ikke kaukasiere.
English: Each carton contains a high density polyethylene (HDPE) bottle with a polypropylene child-resistant closure with silica gel desiccants.
Danish: Hver karton indeholder en højdensitetspolyethylen (HDPE)-flaske med et børnesikret polypropylenlåg med silicagel-tørremiddel.
English: Bone toxicity was diagnosed as osteomalacia (monkeys) and reduced bone mineral density (BMD) (rats and dogs).
Danish: Knogletoksicitet blev diagnosticeret som osteomalaci (aber) og reduceret knoglemineraltæthed (BMD) (rotter og hunde).
English: Tenofovir diphosphate inhibits the activity of HIV-1 RT by competing with the natural substrate deoxyadenosine 5´-triphosphate and, after incorporation into DNA, by DNA chain termination.
Danish: Tenofovirdifosfat hæmmer aktiviteten af hiv-1-RT ved at konkurrere med det naturlige substrat deoxyadenosin-5´-trifosfat og, efter inkorporering i DNA, ved DNA-kæde-terminering.
English: Subjects were randomized to either switch to Delstrigo at baseline [N= 447, Immediate Switch Group (ISG)], or stay on their baseline regimen until Week 24, at which point they switched to Delstrigo [N= 223, Delayed Switch Group (DSG)].
Danish: Forsøgspersonerne blev randomiseret til enten at skifte til Delstrigo ved baseline [N=447, Immediate Switch Group (ISG)] eller blive på deres baseline-regime indtil uge 24, hvor de skiftede til Delstrigo [N=223, Delayed Switch Group (DSG)].
English: One subject developed RT M184M/I mutation and phenotypic resistance to 3TC and FTC during treatment with their baseline regimen.
Danish: En forsøgsperson udviklede RT M184M/I-mutation og fænotypisk resistens over for 3TC og FTC under behandlingen med baselineregimet.
English: 5, abdominal distension, dyspepsia, faeces soft gastrointestinal motility disorder
Danish: 5, abdominal distension, dyspepsi, blød afføring gastrointestinale motilitetsforstyrrelser pankreatitis*
English: Special care is advised in this age group due to age associated changes such as decreases in renal function (see section 4.4).
Danish: Særlig forsigtighed tilrådes hos denne aldersgruppe på grund af aldersrelaterede forandringer, f.eks. tiltagende nedsat nyrefunktion (se pkt.
English: • abnormal dreams, difficulty in sleeping (insomnia)
Danish: • unormale drømme, søvnbesvær (søvnløshed)
English: Doravirine is a pyridinone non-nucleoside reverse transcriptase inhibitor of HIV-1 and inhibits HIV-1 replication by non-competitive inhibition of HIV-1 reverse transcriptase (RT).
Danish: Doravirin er en pyridinon-non-nukleosid-revers transkriptasehæmmer af hiv-1 og hæmmer hiv-1replikation ved non-kompetitiv hæmning af hiv-1-revers transkriptase (RT).
English: Intracellularly, lamivudine is phosphorylated to its active 5´- triphosphate metabolite, lamivudine triphosphate (3TC-TP).
Danish: Intracellulært fosforyleres lamivudin til dets aktive 5´-trifosfatmetabolit, lamivudintrifosfat (3TC-TP).
English: Warnings and precautions Talk to your doctor, pharmacist, or nurse before taking Delstrigo.
Danish: Advarsler og forsigtighedsregler Kontakt lægen, apotekspersonalet eller sygeplejersken, før du tager Delstrigo.
English: If you take more Delstrigo than you should Do not take more than the recommended dose.
Danish: Du må ikke tage mere end den anbefalede dosis.
English: Arthralgias and muscle pain or weakness have also been reported in cases of proximal renal tubulopathy.
Danish: Artralgier og muskelsmerter eller -svaghed er også rapporteret i tilfælde med proksimal renal tubulopati.
English: • carbamazepine, oxcarbazepine, phenobarbital, phenytoin
Danish: • carbamazepin, oxcarbazepin, phenobarbital, phenytoin
English: Following oral administration of a single 245 mg dose of tenofovir disoproxil to HIV-1-infected subjects in the fasted state, Cmax was achieved in one hour.
Danish: Efter oral administration af en enkelt 245 mg dosis tenofovirdisoproxil til hiv-1-inficerede forsøgspersoner i fastende tilstand blev Cmax nået på en time.
English: Subjects must have been virologically suppressed (HIV-1 RNA < 40 copies/mL) on their baseline regimen for at least 6 months prior to trial entry, with no history of virologic failure, and a documented absence of RT substitutions conferring resistance to doravirine, lamivudine and tenofovir (see section, Resistance).
Danish: Forsøgspersonerne skal have været virologisk supprimerede (hiv-1 RNA < 40 kopier/ml) på deres baseline-regime i mindst 6 måneder før indtræden i studiet, uden virologisk svigt i anamnesen, og med dokumenteret fravær af RT-substitutioner, der kan give resistens over for doravirin, lamivudin og tenofovir (se afsnittet Resistens).
English: • inflammation of the skin due to allergy, redness on the cheeks, nose, chin or forehead, bumps or pimples on the face, swelling of the face, lips, tongue or throat
Danish: • inflammation i huden på grund af allergi, rødme på kinder, næse, hage eller pande, buler eller bumser i ansigtet, hævelse af ansigt, læber, tunge eller svælg
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Danish: I hver hyppighedsgruppe er bivirkningerne opstillet efter faldende alvorlighed.
English: At baseline, the median age of subjects was 33 years (range 18 to 69 years), 86 % had CD4
Danish: Ved baseline var forsøgspersonernes medianalder 33 år (interval 18-69 år), 86% havde et CD4
English: Findings in the rat and monkey studies indicated that there was a substance related decrease in intestinal absorption of phosphate with potential secondary reduction in BMD.
Danish: Fund ved studier med rotter og aber viste, at der var en stofrelateret reduktion i den intestinale absorption af fosfat med potentiel, sekundær reduktion af BMD.
English: After multiple-dose oral administration of lamivudine 300 mg once daily for 7 days to 60 healthy subjects, steady-state Cmax (Cmax,ss) was 2.04 ± 0.54 mcg per mL (mean ± SD) and the 24-hour steady-state AUC (AUC24,ss) was 8.87 ± 1.83 mcg•hour per mL.
Danish: Efter oral administration af flere doser lamivudin 300 mg en gang dagligt i 7 dage til 60 raske forsøgspersoner var steady stateCmax (Cmax,ss) 2,04 ± 0,54 µg pr. ml (gennemsnit ± SD), og 24-timers-steady state-AUC (AUC24,ss) var 8,87 ± 1,83 µg•t pr. ml.
English: Metabolism and nutrition disorders Uncommon hypophosphataemia, hypokalaemia*
Danish: Metabolisme og ernæring Ikke almindelig hypofosfatæmi, hypokaliæmi*
English: Uncommon aspartate aminotransferase increased, lipase increased, amylase increased, haemoglobin decreased
Danish: Ikke almindelig forhøjet aspartataminotransferase, forhøjet lipase, forhøjet amylase, nedsat hæmoglobin
English: Animal studies do not indicate harmful effects of doravirine, lamivudine, or tenofovir disoproxil on fertility at exposure levels higher than the exposure in humans at the recommended clinical dose (see section 5.3).
Danish: Dyreforsøg indikerer ingen skadelige virkninger af doravirin, lamivudin eller tenofovirdisoproxil på fertilitet ved eksponeringsniveauer højere end eksponeringen hos mennesker ved den anbefalede kliniske dosis (se pkt.
English: Baseline regimen = ritonavir or cobicistat-boosted PI (specifically atazanavir, darunavir, or lopinavir), or cobicistat-boosted elvitegravir, or NNRTI (specifically efavirenz, nevirapine, or rilpivirine), each administered with two NRTIs.
Danish: Baseline-regime = ritonavir- eller cobicistat-boostet PI (især atazanavir, darunavir eller lopinavir), eller cobicistat-boostet elvitegravir eller NNRTI (især efavirenz, nevirapin eller rilpivirin), hver især administreret sammen med to NRTIer.
English: Excipient with known effect Each film-coated tablet contains 8.6 mg lactose (as monohydrate).
Danish: Hver filmovertrukken tablet indeholder 8,6 mg lactose (som monohydrat).
English: Doravirine steady state pharmacokinetics following administration of 100 mg once daily to HIV-1 infected subjects, based on a population pharmacokinetics analysis are provided below.
Danish: Doravirins farmakokinetik ved steady state efter administration af 100 mg en gang dagligt til hiv-1-inficerede forsøgspersoner på baggrund af en farmakokinetisk populationsanalyse er vist nedenfor.
English: If appropriate, initiation of anti-hepatitis B therapy may be warranted, especially in patients with advanced liver disease or cirrhosis, since post-treatment exacerbation of hepatitis may lead to hepatic decompensation and liver failure.
Danish: Hvis det er relevant, kan initiering af anti-hepatitis Bbehandling være berettiget, særligt hos patienter med fremskreden leversygdom eller levercirrose, da eksacerbation af hepatitis efter behandling kan føre til leverdekompensation og leversvigt.
English: However, co-administration of doravirine and the sensitive CYP3A substrate midazolam resulted in a 18 % decrease in midazolam exposure, suggesting that doravirine may be a weak CYP3A inducer.
Danish: Samtidig administration af doravirin og det følsomme CYP3A-substrat midazolam gav dog et fald på 18% i eksponering for midazolam, hvilket tyder på, at doravirin kan være en svag CYP3A-induktor.
English: • 1 bottle with 30 film-coated tablets
Danish: • 1 flaske med 30 filmovertrukne tabletter
English: Do not give this medicine to anybody aged less than 18 years.
Danish: Børn og unge Dette lægemiddel må ikke anvendes til personer under 18 år.
English: Calcium Channel Blockers diltiazem verapamil
Danish: Calciumantagonister diltiazem verapamil
English: • muscle symptoms (pain, stiffness)
Danish: • muskelsymptomer (smerter, stivhed)
English: Oral carcinogenicity studies in rats and mice only revealed a low incidence of duodenal tumours at an extremely high-dose in mice.
Danish: Karcinogenicitetsstudier med oral administration hos rotter og mus viste kun en lav incidens af duodenale tumorer ved en ekstremt høj dosis hos mus.
English: In patients at risk of renal dysfunction, including patients who have previously experienced renal events while receiving adefovir dipivoxil, it is recommended that estimated CrCl, serum phosphorus, urine glucose, and urine protein be assessed prior to initiation of Delstrigo and more frequent renal function monitoring should be assessed as appropriate per the patient's medical condition during Delstrigo therapy.
Danish: Hos patienter med risiko for dysfunktion af nyrerne, herunder patienter, der tidligere har oplevet nyrerelaterede hændelser, mens de fik adefovirdipivoxil, anbefales det at vurdere estimeret CrCl, serumfosfor, uringlucose og urinprotein, før behandling med Delstrigo initieres, og under behandlingen med Delstrigo skal der foretages hyppigere monitorering af nyrefunktionen efter behov i henhold til patientens medicinske tilstand.
English: A moderate amount of data on pregnant women (between 300-1,000 pregnancy outcomes) indicate no malformations or foetal/neonatal toxicity associated with tenofovir disoproxil.
Danish: Data fra et begrænset antal gravide kvinder (mellem 300 og 1.000) indikerer ingen misdannelser eller føtal/neonatal toksicitet associeret med tenofovirdisoproxil.
English: If your doctor decides you should take these medicines with Delstrigo, your doctor will prescribe a 100 mg tablet of doravirine to be taken daily, approximately 12 hours after your dose of Delstrigo.
Danish: Hvis lægen beslutter, at du skal tage disse lægemidler sammen med Delstrigo, vil lægen ordinere en 100 mg tablet doravirin, som du skal tage dagligt, ca. 12 timer efter at du har taget Delstrigo.
English: • feeling of incomplete defecation
Danish: • følelse af ufuldstændig tømning efter afføring
English: Subjects whose virus expressed an L74V RT substitution without zidovudine resistance-associated substitutions (n = 8) had reduced response to tenofovir disoproxil.
Danish: Forsøgspersoner, hvis virus udtrykte en L74V-RT-substitution uden zidovudin-resistens-associerede substitutioner (n=8), havde reduceret respons på tenofovirdisoproxil.
English: In most singledose trials in HIV-1 infected subjects, or healthy subjects with serum sampling for 24 hours after dosing, the observed mean elimination half-life (t½) ranged from 5 to 7 hours.
Danish: I de fleste enkeltdosisstudier med hiv-1-inficerede forsøgspersoner, eller raske forsøgspersoner med serumprøvetagning over 24 timer efter dosering, lå den observerede gennemsnitlige eliminationshalveringstid (t½) i intervallet 5 til 7 timer.
English: Patients should be informed that fatigue, dizziness, and somnolence have been reported during treatment with Delstrigo (see section 4.8).
Danish: Patienterne skal informeres om, at der er rapporteret træthed, svimmelhed og døsighed under behandlingen med Delstrigo (se pkt.
English: + T'.
Danish: + T-celler'.
English: Blood tests may also show: • failure of the bone marrow to produce new red blood cells (pure red cell aplasia)
Danish: Blodprøver kan også vise: • manglende dannelse af nye røde blodlegemer i knoglemarven (ren erytrocyt aplasi).
English: The M184I/V lamivudine resistance substitution confers resistance to emtricitabine.
Danish: Lamivudin-resistens-substitutionen M184I/V medfører resistens over for emtricitabin.
English: • This medicinal product does not require any special temperature storage conditions.
Danish: • Der er ingen særlige krav vedrørende opbevaringstemperaturer for dette lægemiddel.
English: If Delstrigo is co-administered with rifabutin, the doravirine dose should be increased to 100 mg twice daily.
Danish: Hvis Delstrigo administreres sammen med rifabutin, skal dosis af doravirin øges til 100 mg to gange dagligt.
English: The efficacy of doravirine is based on the analyses of 96-week data from two randomised, multicentre, double-blind, active controlled Phase 3 trials, (DRIVE-FORWARD and DRIVE-AHEAD) in antiretroviral treatment-naïve, HIV-1 infected subjects (n = 1494).
Danish: Doravirins virkning er baseret på analyserne af 96 ugers data fra to randomiserede, dobbeltblindede, aktivt kontrollerede fase 3-multicenterstudier (DRIVE-FORWARD og DRIVE-AHEAD) hos hiv-1inficerede forsøgspersoner, der ikke tidligere havde fået antiretroviral behandling (n=1.494).