Table 2.
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.