Table 2. Virology, immunology and secondary endpoints over all follow-up.

	Short cycle therapy	Continuous Therapy	p-value
Young people randomised and included	99	100
Median weeks from randomisation [IQR] (range)	186.1 [162.3–216.1] (82.0, 264.0)	183.3 [159.8–216.1] (25.0, 262.4)
Virology Endpoints
Confirmed VL ≥50copies/mL by 144 weeks	15 (15)	13 (13)	0.72
Confirmed VL ≥50copies/mL over all follow-up*	16	16
During main trial	10	10
During extended follow up	6	6
Incidence of confirmed VL≥50 copies/mL over all follow-up per 100 PYs (95% CI)	4.88 (2.99, 7.97)	4.88 (2.99, 7.97)	0.99
Confirmed VL ≥400copies/mL by 144 weeks	9 (9)	8 (8)	0.78
VL <50copies/mL at 96 weeks×	77 (92)	76 (93)	1.00
VL <50copies/mL at 144 weeks×	71 (93)	71 (90)	0.57
Other Endpoints
Immunology
Mean change in CD4 T+ cell count by 96 weeks, cells/μL	-18.1 (24.3) ‡†	-38.6 (25.0) ‡†	0.56‡
Mean change in CD4% by 96 weeks	-0.1 (0.5) ‡§	-0.6 (0.5) ‡§	0.50‡
Mean change in CD4 T+ cell count by 144 weeks, cells/ μL	16.9 (24.5) ‡†	-19.5 (24.8) ‡†	0.31‡
Mean change in CD4% by 144 weeks	1.0 (0.6) ‡§	0.0 (0.6) ‡§	0.25‡
Resistance in participants with confirmed VL ≥50copies/ml
Number of young people with any major mutations/     Number of young people with available sequences	5/8∞	12/13∞
Number without resistance	3	1
Number with NNRTI mutations only	3	7
Number with NRTI and NNRTI mutations	2	5

Data are n (%) or mean change from randomisation (standard error) unless otherwise stated. VL = viral load; NNRTI = non-nucleoside reverse transcriptase inhibitors; NRTI = nucleoside reverse transcriptase inhibitors.

*All follow-up includes all data available until the last randomised patient reached 144 weeks. × Cross-sectional analyses, participants missing viral load at time point are missing outcome.

†79 and 73 young people (YP) in short cycle therapy arm and 75 and 71 YP in continuous therapy arm had CD4 T+ cell count available at baseline and week 96 and baseline and week 144, respectively.

§80 and 75 YP in short cycle therapy arm and 79 and 76 YP in continuous therapy arm had available CD4% at baseline and week 96 and baseline and week 144, respectively.

‡Change in CD4 and CD4% adjusting for baseline CD4/CD4% and stratification factors.

∞6 samples (4SCT, viral loads = 56 copies/mL, 144 copies/mL, 126 copies/mL, 62 copies/mLl and 2CT, viral load = 231 copies/mL, 75 copies/mL) from young people who experienced virological failure in the main trial failed to amplify. 5YP did not have a stored sample available for testing (4 SCT and 1 CT).