Table 1.

Entry and baseline characteristics of study populations

Characteristic	All enrolled (N = 32)	Included in safety analysis (n = 30)	Primary efficacy populationa (n = 16)	Secondary efficacy populationb (n = 13)
Age at study entry
Median (Q1, Q3)	52 (46, 55)	52 (46, 55)	52 (43, 59)	52 (46, 53)
Female gender
N (%)	9 (28%)	7 (23%)	3 (19%)	3 (23%)
Race/Ethnicity
White Non-Hispanic	9 (28%)	8 (27%)	6 (38%)	2 (15%)
Black Non-Hispanic	18 (56%)	18 (60%)	7 (44%)	10 (77%)
Hispanic	4 (13%)	3 (10%)	2 (13%)	1 (8%)
More than one race	1 (3%)	1 (3%)	1 (6%)	0 (0%)
IV drug history
Never used	29 (91%)	27 (90%)	14 (88%)	12 (92%)
Previously	3 (9%)	3 (10%)	2 (12%)	1 (8%)
Entry HIV plasma RNA
≥40 copies/mL	0 (0%)	0 (0%)	0 (0%)	13 (100%)
Txt week 0 HIV plasma RNA
≥40 copies/mL	1 (3%)	1 (3%)	0 (0%)	1 (8%)
Baseline CD4+ T cell count (c/mm3)
Median (Q1, Q3)	813 (618, 1,014)	818 (635, 1,031)	846 (662, 1,065)	765 (635, 972)
Baseline CD4/CD8+ ratio
Median (Q1, Q3)	0.9 (0.7, 1.3)	0.9 (0.7, 1.3)	0.9 (0.7, 1.4)	1.0 (0.8, 1.3)
Baseline weight (kg)
Median (Q1, Q3)	83 (68, 99)	83 (68, 99)	79 (64, 93)	90 (77, 100)
Baseline BMI (kg/m2)
Median (Q1, Q3)	27 (23, 31)	27 (23, 30)	24 (22, 29)	29 (26, 31)
Entry ARV regimen
Non-PI, non-NNRTI (INSTI) based	14 (44%)	13 (43%)	9 (56%)	4 (31%)
Non-PI, RPV based	3 (9%)	2 (7%)	1 (6%)	1 (8%)
Non-PI, other NNRTI based	15 (47%)	15 (50%)	6 (38%)	8 (62%)c

IV, intravenous; BMI, body mass index; ARV, antiretroviral; PI, protease inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; INSTI, integrase strand transfer inhibitor; RPV, rilpivirine. Baseline is the average of pre-sirolimus measurements at study weeks 0 and 12.

^aIncludes participants who completed the full 20 weeks of sirolimus.

^bIncludes participants who completed 6 to 16 weeks of sirolimus.

^cParticipants in the primary efficacy population had lower efavirenz (NNRTI) use than in secondary efficacy population (38% versus 62%).