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. 2017 Sep 11;7(9):e019022. doi: 10.1136/bmjopen-2017-019022

Table 2.

Study characteristics of HIV-positive pregnant and non-pregnant adults randomised to different NRTI regimens, combined with the same third antiretroviral agent

Authors, year Design Study period Setting Population Sample size Age Third ARV NRTI comparison
Campbell, 201235 RCT 2005–2007 Brazil, Haiti, India, Malawi, Peru, South Africa, Thailand, USA, Zimbabwe Antiretroviral-naïve, CD4 <350 cells/μL 1042 Median 34 Efavirenz TDF/FTC versus AZT/3TC
Fowler et al, 2016 (PROMISE)12 RCT 2012–2014 India, Malawi, South Africa,
Tanzania, Uganda, Zambia, Zimbabwe
Pregnant women,
CD4 ≥350 cells/μL
694 Median 26 (IQR 22–30) Lopinavir boosted with ritonavir TDF/FTC versus AZT/3TC
Gallant, 200643 RCT 2003–2004 France, Germany, Italy, Spain, UK, USA Antiretroviral-naïve, HIV viral load >10 000 copies/mL 509 Median 36.5 Efavirenz TDF/FTC versus AZT/3TC
Nishijima, 201344 RCT 2007–2010 Japan Antiretroviral-naïve, CD4 <350 cells/μL 107 Median 36 (IQR 29–42.5) Atazanavir boosted with ritonavir TDF/FTC versus ABC/3TC
Post, 201045 RCT 2007 13 European countries Antiretroviral-naïve, HIV viral load ≥1000 copies/mL 385 Median 37 (range 18–70) Efavirenz TDF/FTC versus ABC/3TC
Rey, 200946 RCT 2005–2006 France Antiretroviral-naïve, CD4 <350 cells/μL for men and <250 cells/μL for women 71 Mean 41.4 (range 24–74) Nevirapine TDF/FTC versus AZT/3TC
Sax, 200947 48 RCT 2005–2007 USA Antiretroviral-naïve 1857 Median 39 (IQR 32–45) Atazanavir boosted with ritonavir or efavirenz* TDF/FTC versus ABC/3TC
Smith, 200949 RCT 2005–2006 Puerto Rico, USA Antiretroviral-naïve, HIV viral load ≥1000 copies/mL 688 Median 38 Lopinavir boosted with ritonavir TDF/FTC versus ABC/3TC

*Patients with an HIV viral load <10 000 copies/mL were also randomised to receive atazanavir boosted with ritonavir or efavirenz; patients with higher viral loads all received atazanavir boosted with ritonavir.

3TC, lamivudine; ABC, abacavir; ARV, antiretroviral; AZT, zidovudine; FTC, emtricitabine; NRTI, nucleoside/nucleotide reverse transcriptase inhibitors; PROMISE, Promoting Maternal and Infant Survival Everywhere; RCT, randomised controlled trial; TDF, tenofovir disoproxil fumarate.