***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: ABSTRACT Background Patients infected with HIV-1 initiating antiretroviral therapy ( ART ) containing a non-nucleoside reverse transcriptase inhibitor ( NNRTI )  show presumably fewer atherogenic lipid changes than those initiating most ARTs containing a protease inhibitor . We analysed whether lipid changes differed between the two most commonly used NNRTIs , nevirapine ( NVP ) and efavirenz ( EFV ) . Methods and Findings Prospect i ve analysis of lipids and lipoproteins was performed in patients enrolled in the NVP and EFV treatment groups of the 2NN study who remained on allocated treatment during 48 wk of follow-up . Patients were allocated to  NVP ( n = 417 ) , or EFV ( n = 289 ) in combination with stavudine and lamivudine . The primary endpoint was percentage change over 48 wk in high-density lipoprotein cholesterol ( HDL-c ) , total cholesterol ( TC ) , TC : HDL-c ratio , non-HDL-c , low-density lipoprotein cholesterol , and triglycerides . The increase of HDL-c was significantly larger for patients receiving NVP ( 42.5 % ) than for patients receiving EFV ( 33.7 % ; p = 0.036 ) , while the increase in TC was lower ( 26.9 % and 31.1 % , respectively ; p = 0.073 ) , result ing in a decrease of the TC : HDL-c ratio for patients receiving NVP ( −4.1 % ) and an increase for patients receiving EFV ( + 5.9 % ; p < 0.001 ) . The increase of non-HDL-c was smaller for patients receiving NVP ( 24.7 % ) than for patients receiving EFV ( 33.6 % ; p = 0.007 ) , as were the increases of triglycerides ( 20.1 % and 49.0 % , respectively ; p < 0.001 ) and low-density lipoprotein cholesterol ( 35.0 % and 40.0 % , respectively ; p = 0.378 ) . These differences remained , or even increased , after adjusting for changes in HIV-1 RNA and CD4 + cell levels , indicating an effect of the drugs on lipids over and above that which may be explained by suppression of HIV-1 infection . The increases in HDL-c were of the same order of magnitude as those seen with the use of the investigational HDL-c-increasing drugs . Conclusion NVP-containing ART shows larger increases in HDL-c and decreases in TC : HDL-c ratio than an EFV-containing regimen . Based on these findings , protease-inhibitor-sparing regimens based on non-nucleoside reverse transcriptase inhibitor , particularly those containing NVP , may be expected to result in a reduced risk of coronary heart disease Objective : To evaluate atazanavir/ritonavir ( ATV/RTV ) ( 300/100 mg ) once daily , atazanavir/saquinavir ( ATV/SQV ) ( 400/1200 mg ) once daily , and lopinavir/ritonavir ( LPV/RTV ) ( 400/100 mg ) twice daily , each with tenofovir ( 300 mg ) once daily and a nucleoside reverse transcriptase inhibitor in treatment-experienced HIV-infected patients . Methods : R and omized , open-label , 48-week multicenter trial of 358 r and omized adult patients who had failed two or more prior HAART regimens with baseline HIV RNA ≥ 1000 copies/ml and CD4 cell count ≥ 50 × 106 cells/l . Results : The primary efficacy endpoint [ plasma HIV RNA reduction assessed by time-averaged difference ( TAD ) ] was similar for ATV/RTV and LPV/RTV [ TAD 0.13 ; 97.5 % confidence interval , −0.12 to 0.39 ] at 48 weeks . Mean reductions from baseline for ATV/RTV and LPV/RTV were comparable at 1.93 and 1.87 log10 copies/ml , respectively . Mean CD4 cell count increases were 110 and 121 × 106 cells/l for ATV/RTV , and LPV/RTV , respectively . The efficacy  of ATV/SQV was lower than LPV/RTV by both these parameters . Declines in total cholesterol and fasting triglycerides were greater with ATV/RTV and ATV/SQV than with LPV/RTV ( P ≤ 0.005 ) . Lipids in the LPV/RTV arm at week 48 generally increased from baseline . Lipid-lowering agents were used more frequently in the LPV/RTV arm than in the ATV arms ( P < 0.05 versus ATV/RTV ) , as were antidiarrheal agents ( P ≤ 0.04 versus both ATV treatments ) . No new or unique safety findings emerged . Conclusions : ATV boosted with RTV is as effective and well tolerated as LPV/RTV in treatment-experienced patients , with a more favorable impact on serum lipids . Pharmacokinetically enhanced ATV provides a suitable choice for therapy of treatment-experienced HIV-infected patients CONTEXT Selective reporting of outcomes within published studies based on the nature or direction of their results has been widely suspected , but direct evidence of such bias is currently limited to case reports . OBJECTIVE To study empirically the extent and nature of outcome reporting bias in a cohort of r and omized trials . DESIGN Cohort study using protocol s and published reports of r and omized trials approved by the Scientific-Ethical Committees for Copenhagen and Frederiksberg , Denmark , in 1994 - 1995 . The number and characteristics of reported and unreported trial outcomes were recorded from protocol s , journal articles , and a survey of trialists . An outcome was considered incompletely reported if insufficient data were presented in the published articles for meta- analysis . Odds ratios relating the completeness of outcome reporting to statistical significance were calculated for each trial and then pooled to provide an overall estimate of bias . Protocol s and published articles were also compared to identify discrepancies in primary outcomes . MAIN OUTCOME MEASURES Completeness of reporting of efficacy and harm outcomes and of statistically significant vs nonsignificant outcomes ; consistency between primary outcomes defined in the most recent protocol s and those defined in published articles . RESULTS One hundred two trials with 122 published journal articles and 3736 outcomes were identified . Overall , 50 % of efficacy and 65 % of harm outcomes per trial were incompletely reported . Statistically significant outcomes had a higher odds of being fully reported compared with nonsignificant outcomes for both efficacy ( pooled odds ratio , 2.4 ; 95 % confidence interval [ CI ] , 1.4 - 4.0 ) and harm ( pooled odds ratio , 4.7 ; 95 % CI , 1.8 - 12.0 ) data . In comparing published articles with protocol s , 62 % of trials had at least 1 primary outcome that was changed , introduced , or omitted . Eighty-six percent of survey responders ( 42/49 ) denied the existence of unreported outcomes despite clear evidence to the contrary . CONCLUSIONS The reporting of trial outcomes is not only frequently incomplete but also biased and inconsistent with protocol s. Published articles , as well as review s that incorporate them , may therefore be unreliable and overestimate the benefits of an intervention . To ensure transparency , planned trials should be registered and protocol s should be made publicly available prior to trial completion Background : In BMS Study 045 , once-daily ( QD ) atazanavir/ritonavir ( ATV/RTV ) demonstrated comparable efficacy and safety to twice-daily ( BID ) lopinavir/ritonavir ( LPV/RTV ) over 48 weeks in treatment-experienced patients . Results of extended follow-up to 96 weeks are presented . Methods : BMS Study 045 was an open-label , r and omized , multi-national trial of HIV-infected patients with virologic failure on two or more prior HAART regimens design ed to evaluate the efficacy and safety of ATV/RTV ( 300/100 mg ) QD and LPV/RTV ( 400/100 mg ) BID , each with tenofovir ( 300 mg ) QD and one nucleoside reverse transcriptase inhibitor . The primary efficacy measure was the time-averaged difference ( TAD ) in reduction in HIV RNA from baseline . Secondary objectives included evaluation of safety and plasma lipid levels through week 96 . Results : Over 96 weeks , the ATV/RTV regimen demonstrated similar virologic efficacy to the LPV/RTV regimen . Mean reductions from baseline in HIV RNA were −2.29 and −2.08 log10 copies/ml , respectively [ TAD ( 97.5 % confidence interval ) : 0.14 log10 copies/ml ( −0.13 , 0.41 ) ] . The LPV/RTV regimen result ed in significant increases in total cholesterol ( + 9 % ) and fasting triglycerides ( + 30 % ) in comparison with the ATV/RTV regimen , which demonstrated decreases in these parameters [ −7 and −2 % , respectively , ( P < 0.0001 ) ] . Grade 2–4 diarrhoea occurred less frequently in ATV/RTV patients ( 3 % ) in comparison with LPV/RTV patients ( 13 % ) ( P < 0.01 ) . Grade 3–4 elevations in bilirubin were more common in ATV/RTV patients ( 53 % ) than LPV/RTV patients ( < 1 % ) ( P < 0.0001 ) , with no result ing discontinuations . Conclusions : Regimens containing once-daily ATV/RTV demonstrated comparable efficacy and safety , with significant reductions in total cholesterol and fasting triglycerides and improved gastrointestinal-tolerability in comparison with twice-daily regimens containing LPV/RTV over 96 weeks in treatment-experienced patients Two hundred and twelve HIV-positive patients who started a new protease inhibitor (PI)-based antiretroviral regimen between January 1998 and December 2000 in our tertiary care centre were prospect ively followed-up during a 12-month study period , in order to assess the incidence of hyperlipidaemia and related clinical adverse events . At the end of 1-year follow-up , PI-containing antiretroviral treatment led to a statistically significant increase in serum triglyceride levels ( P<0.005 ) and total and LDL-cholesterol levels ( P<0.05 ) . The overall incidence of hypertriglyceridaemia and hypercholesterolaemia was 38.2 and 25 % , respectively . The incidence of increased serum triglyceride levels was significantly higher in patients treated with ritonavir ( 66.6 % ) or lopinavir/ritonavir ( 60.7 % ) , compared with other PIs ( P<0.04 ) . Clinical adverse events possibly related to the hyperlipidaemia ( such as cardiovascular diseases or acute pancreatitis ) were not observed during the entire 12 months study period . In conformity with other previously published studies , the very high incidence of hyperlipidaemia during a PI-based therapy recognised in our work raises a big concern about its potential clinico-pathological consequences and the most convenient pharmacological management of these metabolic imbalances Background : Atazanavir ( ATV ) , the first once-daily protease inhibitor approved for the treatment of HIV-1 infection , is recommended for use in antiretroviral ( ARV ) treatment-naive and -experienced patients . Study AI424 - 089 was a prospect i ve , r and omized , open-label , 96-week study comparing 2 ATV-based treatment regimens in ARV-naive HIV-infected patients . Methods : Adults with HIV RNA levels ≥2000 copies/mL were r and omized ( 1:1 ) to once-daily ATV at a dose of 300 mg with ritonavir at a dose of 100 mg ( ATV300/RTV ) or ATV at a dose of 400 mg ( ATV400 ) ; both regimens included lamivudine and an investigational extended-release formulation of stavudine . The primary endpoint for this noninferiority study was the proportion of patients ( response rate ) with an HIV RNA load < 400 copies/mL at week 48 . Results : Response rates at week 48 were 86 % and 85 % on the ATV300/RTV and ATV400 regimens , respectively ( difference estimate [ 95 % confidence interval ] = 1.5 [ −8.2 to 11.1 ] ) . There were 3 and 10 patients with virologic failure in the ATV300/RTV and ATV400 groups , respectively . One patient ( ATV400 ) developed phenotypic resistance to ATV associated with an I50L substitution . Adverse event-related discontinuations were 8 % among ATV300/RTV-treated patients and < 1 % among ATV400-treated patients . Plasma lipid elevations were low with both regimens . Both regimens were well tolerated . Conclusions : These findings demonstrate the safety and efficacy of the ATV300/RTV regimen and confirm the safety and efficacy of ATV400 in an ARV-naive patient population B 
    Output:
    
At 48 weeks , plasma lipid concentrations were lower with atazanavir/ritonavir than with other ritonavir-boosted protease inhibitor regimens .
Total and non-HDL cholesterol were higher with atazanavir/ritonavir than atazanavir alone