Table 1 Baseline demographic and clinical characteristics of the study population

From: Dolutegravir restores gut microbiota in late-stage HIV-1 unlike darunavir: an open-label, randomized clinical trial

Characteristic

N

Overall

N = 79

Darunavir/ritonavir (DRV/r)

N = 39

Dolutegravir (DTG)

N = 40

SMDa

Age (years), Median (Q1, Q3)

79

40 (31, 48)

41 (34, 47)

38 (30, 49)

0.27

Gender, n (%)

79

   

0.06

 Female

 

13 (16%)

6 (15%)

7 (18%)

 

 Male

 

66 (84%)

33 (85%)

33 (83%)

 

Ethnic group, n (%)

78

   

0.51

 Asian

 

1 (1.3%)

0 (0%)

1 (2.5%)

 

 Black

 

6 (7.7%)

4 (11%)

2 (5.0%)

 

 Caucassian

 

32 (41%)

13 (34%)

19 (48%)

 

 Hispanic

 

31 (40%)

15 (39%)

16 (40%)

 

 Other

 

8 (10%)

6 (16%)

2 (5.0%)

 

 Unknown

 

1

1

0

 

Risk group, n (%)

79

   

0.29

 HTS

 

34 (43%)

19 (49%)

15 (38%)

 

 MSM

 

42 (53%)

18 (46%)

24 (60%)

 

 Unknown

 

3 (3.8%)

2 (5.1%)

1 (2.5%)

 

Center, n (%)

79

   

0.47

 01

 

32 (41%)

17 (44%)

15 (38%)

 

 02

 

15 (19%)

6 (15%)

9 (23%)

 

 03

 

14 (18%)

6 (15%)

8 (20%)

 

 04

 

3 (3.8%)

3 (7.7%)

0 (0%)

 

 05

 

9 (11%)

4 (10%)

5 (13%)

 

 06

 

6 (7.6%)

3 (7.7%)

3 (7.5%)

 

BMI, Median (Q1, Q3)

78

22.1 (20.1, 24.4)

22.1 (19.7, 24.4)

22.1 (21.0, 24.4)

−0.16

 Unknown

 

1

0

1

 

BMI class, n (%)

78

   

0.12

 Healthy weight (18.5–24.9)

 

56 (72%)

27 (69%)

29 (74%)

 

 Overweight (25–29.9)

 

15 (19%)

8 (21%)

7 (18%)

 

 Underweight (<18.5)

 

7 (9.0%)

4 (10%)

3 (7.7%)

 

 Unknown

 

1

0

1

 

CD4+ T cells (cells/mm3), Median (Q1, Q3)

79

33 (13, 67)

23 (8, 42)

41 (18, 75)

−0.58

CD4+ T cell count nadir (cells/mm3), Median (Q1, Q3)

79

35 (13, 60)

30 (10, 50)

38 (19, 67)

−0.56

CD8+ T cells (cells/mm3), Median (Q1, Q3)

79

582 (342, 853)

554 (234, 750)

636 (404, 884)

−0.14

CD4+ CD38+ HLA-DR+ T cells (cells/mm3), Median (Q1, Q3)

79

28 (15, 36)

28 (17, 36)

27 (15, 39)

0.07

CD8+ CD38+ HLA-DR+ T cells (cells/mm3), Median (Q1, Q3)

79

44 (31, 55)

41 (31, 54)

47 (32, 60)

−0.23

IL-6 (pg/mL), Median (Q1, Q3)

55

19 (10, 32)

16 (8, 26)

20 (11, 44)

−0.31

Unknown

 

24

13

11

 

TNF-a (pg/mL), Median (Q1, Q3)

79

16 (13, 21)

15 (13, 18)

18 (16, 24)

−0.29

sCD14 (pg/mL), Median (Q1, Q3)

79

2708 (2156, 3624)

2788 (2156, 3776)

2706 (2078, 3550)

0.07

CRP (mg/L), Median (Q1, Q3)

79

0.22 (0.11, 0.77)

0.26 (0.12, 0.83)

0.20 (0.10, 0.68)

−0.40

7 Standardized Mean Difference

HIV viral load (copies/mL), Median (Q1, Q3)

79

366,000 (98,197, 1,399,754)

373,348 (132,573, 1,399,754)

345,066 (71,844, 1,631,869)

−0.03

CMV viral load (copies/mL), Median (Q1, Q3)

79

35 (0, 155)

35 (0, 140)

35 (0, 178)

−0.41

CMV status, n (%)

79

   

0.19

 Negative

 

30 (38%)

13 (33%)

17 (43%)

 

 Positive

 

49 (62%)

26 (67%)

23 (58%)

 

Gene richness, Median (Q1, Q3)

70

756,557 (618,951, 931,126)

748,385 (613,626, 950,184)

776,668 (638,678, 926,433)

−0.07

 Unknown

 

9

4

5

 
  1. Data are presented as median (Q1, Q3) for continuous variables or n (%) for categorical variables. The total study population was N = 79 (darunavir/ritonavir [DRV/r], n = 39; dolutegravir [DTG], n = 40). Standardized mean difference (SMD) was used to assess the balance of baseline characteristics between treatment arms.
  2. The “Unknown” category indicates missing data for the respective clinical or biological parameters.
  3. BMI body mass index, CRP C-reactive protein, HTS heterosexual, IL-6 interleukin-6, MSM men who have sex with men, Q1 first quartile, Q3 third quartile, sCD14 soluble CD14, TNF-a tumor necrosis factor alpha.
  4. aStandardized mean difference.
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