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Background The aim of this study was to investigate long-term renal function in HIV-infected adults initiating antiretroviral therapy (ART) with a CD4+T-cell count <200 cells/mm3in Africa.Methods This was an observational analysis within the DART trial randomizing 3,316 adults to routine laboratory and clinical monitoring (LCM) or clinically driven monitoring (CDM). Serum creatinine was measured pre-ART (all =360 µmol/l), at weeks 4 and 12, then every 12 weeks for 4-5 years; estimated glomerular filtration rate (eGFR) was determined using the Cockcroft-Gault formula. We analysed eGFR changes, and cumulative incidences of eGFR<30 ml/min/1.73 m2and chronic kidney disease (CKD; <60 ml/min/1.73 m2or 25% decrease if <60 ml/min/1.73 m2pre-ART; confirmed >3 months).Results At ART initiation, median CD4+T-cell count was 86 cells/mm3; 1,492 (45%) participants had mild (60–<90 ml/min/1.73 m2), 237 (7%) moderate (30–<60 ml/min/1.73 m2) and 7 (0.2%) severe (15–<30 ml/min/1.73 m2) decreases in eGFR. First-line ART was zidovudine/lamivudine plus tenofovir (74%), abacavir (9%) or nevirapine (17%). By 4 years, cumulative incidence of eGFR<30 ml/min/1.73 m2was 2.8% (n=90) and CKD was 5.0% (n=162). Adjusted eGFR increases to 4 years were 1, 9 and 6 ml/min/1.73 m2with tenofovir, abacavir and nevirapine, respectively (P<0.001), and 4 and 2 ml/min/1.73 m2for LCM and CDM, respectively (P=0.005; 2 and 3 ml/min/1.73 m2to 5 years; P=0.81).Conclusions On all regimens and monitoring strategies, severe eGFR impairment was infrequent; differences in eGFR changes were small, suggesting that first-line ART, including tenofovir, can be given safely without routine renal function monitoring.

Objective To describe the prevalence, incidence and predictors of severe anaemia in previously untreated symptomatic HIV-infected adults with CD4+T-cells <200 cells/mm3initiating zidovudine-containing regimens in Africa.Design DART is a randomized trial comparing two strategies for HIV/AIDS management in Uganda and Zimbabwe.Methods We analysed the occurrence of anaemia at weeks 4 and 12, and then every 12 weeks. We also evaluated sex, age, WHO stage, body mass index (BMI), baseline laboratory measurements and first regimen as predictors of developing grade 4 anaemia (<6.5 mg/dl) by week 48 using logistic regression.Results To May 2005, 3,314 participants (65% women, 23% at WHO stage 4, median age=37 years, baseline CD4+T-cell=86 cells/mm3and median baseline haemo-globin=11.4 g/dl) had a median 72 weeks follow-up. Prevalence of grade 4 anaemia was 0.7%, 2.0%, 0.5% and <0.5% at weeks 4, 12, 24 and =36, respectively. Overall, 219 (6.6%) participants developed grade 4 anaemia by week 48; women and those with lower haemoglobin, CD4+T-cell count and BMI at baseline were at significantly higher risk (P<0.05), but not those with lower neutrophils or receiving cotrimoxazole at baseline.Conclusions We observed a higher incidence of grade 4 anaemia than in studies from industrialized countries, which is likely to be due in part to population characteristics and in part to a higher rate of concurrent HIV-related clinical events. Clinical vigilance and haemoglobin measurements 4, 8 and 12 weeks after starting zidovudine could help to manage serious anaemia.