Núñez 2002.

Methods	A randomized, open‐label, pilot study in Hospital Carlos III in Madrid Span from March 1999 to January 2002
Participants	Eligibility criteria: HIV‐infected antiretroviral‐naïve adults, aged above 18 years old with CD4 counts > 100 cells/mm3 and detectable plasma HIV RNA below 100,000 copies/mL, no major organ failure, use of standard of care prophylaxis for opportunistic infections, negative pregnancy test in women of child‐bearing age, and no current high alcohol intake or substance abuse. N = 67 (NVP = 36, EFV = 31).
Interventions	d4T and ddI with either NVP or EFV at the following doses: NVP 400 mg once a day, d4T 40 mg twice a day, ddI 400 mg once a day, and EFV 600 mg once a day. Follow‐up was for 48 weeks.
Outcomes	Primary: the proportion of individuals achieving plasma HIV RNA < 50 copies/mL and the proportion developing drug‐related toxicities, which caused cessation of the NNRTI. Secondary: mean changes in CD4+ lymphocyte counts, overall safety, degree of adherence, and adverse events.
Notes	All participants provided informed consent to participate in the trial. This trial is referred to as the SENC trial.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Trial authors provided no information on methods of sequence generation
Allocation concealment (selection bias)	Unclear risk	The trial authors did not report this information.
Blinding (performance bias and detection bias) All outcomes	High risk	Open‐label study.
Incomplete outcome data (attrition bias) All outcomes	Low risk	There was no missing outcome data. Three participants were lost to follow‐up right after enrolment.
Selective reporting (reporting bias)	Low risk	The trial authors reported primary and secondary outcomes.
Baseline data reported?	Low risk	The trial authors reported on age, gender, HIV transmission, plasma HIV RNA, absolute CD4 count, number of participants with AIDS, positive anti‐HCV antibody, positive HBsAg.
Other bias	Low risk	This trial was not funded by industry. It was funded by the Asociacíon Investigacíon y Educación en SIDA (AIES) and Comunidad Autónoma de Madrid.