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Table 1 Baseline characteristics of cohort participants selected for the study

From: Maternal HIV infection and the milk microbiome

Variable (mean (SD))

WWoH

WWH

p Value

N

25

24a

 

Parity

2.96 (1.90)

3.21 (1.72)

0.634

Days postpartum

71.44 (56.60)

66.88 (45.78)

0.758

Exclusive breastfeeding (%)

19 (76.0)

19 (79.2)

1

CD4 count (cells/mm3)

NA

573.79 (275.77)

NA

Plasma HIV-1 RNA (log10 copies/mL)

NA

2.31 (1.41)

NA

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Variable (mean (SD))

No maternal ART

Maternal ARTb

p Value

N

25

25

 

Country (%) ^

 Malawi

16 (64)

16 (64)

 

 South Africa

7 (28)

7 (28)

 

 Uganda

1 (4)

1 (4)

 

 Zimbabwe

1 (4)

1 (4)

 

Parity prior to delivery

1.7 (1.3)

1.6 (1.2)

0.91

Gestational age at delivery (weeks)

38.5 (3.3)

38.3 (2.2)

0.81

CD4 count (cells/mm3) ^

555 (166)

557 (166)

0.97

Plasma HIV-1 RNA (log10 copies/mL) ^

3.85 (0.97)

3.63 (0.86)

0.41

Variable (mean (SD))

CD4 ≤ 200

CD4 > 200

p Value

N

20

46

 

Site 1 of 2 (%)

13 (65.0)

28 (60.9)

0.967

Parity prior to delivery

2.15 (1.27)

2.24 (1.45)

0.812

Gestational age at delivery (weeks)

38.43 (4.39)

38.57 (3.43)

0.887

Maternal baseline CD4 mean (SD)

151.25 (45.52)

361.93 (115.03)

 < 0.001

CD4 < or = 350

20 (100.0)

24 (52.2)

 < 0.001

Plasma HIV-1 RNA (log10 copies/mL)

5.05 (0.45)

4.76 (0.68)

0.085

Breast milk HIV-1 RNA (1 month)

 Detectable (%)

9/12 (75.0)

14/25 (56.0)

0.451

 log10 copies/mL (detectable only)

3.27 (1.07)

2.67 (1.00)

0.103

Variable (mean (SD))

Transmitter group

Non-transmitter group

p Value

N

22

44

 

Parity prior to delivery

2.32 (1.64)

2.16 (1.26)

0.66

Gestational age at delivery (weeks)

38.3 (3.71)

38.7 (3.75)

0.65

CD4 Count (cells/mm3) ^

289 (133)

303 (143)

0.71

CD4 < or = 350 (%)

16 (72.7)

28 (63.6)

0.64

CD4 ≤ 200 (%)

7 (31.8)

13 (29.5)

1

Plasma HIV-1 RNA (log10 copies/mL) ^

4.83 (0.68)

4.86 (0.61)

0.85

Breast milk HIV-1 RNA (1 week)

   

 Detectable

5/7 (71.4)

6/11 (54.5)

0.826

 log10 copies/mL

2.83 (1.13)

2.16 (0.70)

0.132

Breast milk HIV-1 RNA (1 month)

   

 Detectable

16/22 (72.7)

7/15 (46.7)

0.208

 log10 copies/mL

3.15 (1.09)

2.43 (0.85)

0.037

Variable (mean (SD))

Transmitter group

Non-transmitter group

p Value

N

21a

42

 

Transmission

 Early mucosal

5

  

 Breast milk

15

  

 Unknown

1

  

Prophylaxis – maternal ART (%)

7 (33.3)

23 (54.8)

0.181

Maternal ART regimen prior to transmission (%)

  

0.324

 3TC,ZDV,LPV/r

0 (0.0)

3 (7.1)

 

 FTC,TDF,LPV/r

6 (28.6)

18 (42.9)

 

 ZDV,sdNVP,FTC,TDF

1 (4.8)

2 (4.8)

 

 No maternal ARVs

14 (66.7)

19 (45.2)

 

Country^ (%)

  

0.252

 India

1 (4.8)

0 (0.0)

 

 Malawi

9 (47.4)

23 (54.8)

 

 South Africa

3 (15.8)

9 (21.4)

 

 Tanzania

1 (4.8)

0 (0.0)

 

 Uganda

3 (15.8)

7 (16.7)

 

 Zimbabwe

4 (21.1)

3 (7.1)

 

Parity prior to delivery

1.19 (1.12)

2.12 (1.11)

0.003

Gestational age at delivery (wks)

37.99 (2.87)

38.05 (3.10)

0.946

CD4 count (cells/mm3) ^

534.38 (188.21)

526.52 (162.35)

0.864

Plasma HIV-1 RNA (log10 copies/mL) ^

4.56 (0.74)

4.03 (0.91)

0.026

  1. WWoH women without HIV, WWH women with HIV, 3tc lamivudine, zdv zidovudine, lpv/r ritonavir-boosted lopinavir, ftc emtricitabine, tdf tenofovir diproxil fumarate, sd. nvp single-dose nevirapine
  2. aNumber of participants selected for the study are shown. Sequences from three participants in the GUMBO WWH and two participants in the PROMISE by Transmission Transmitter Group (one participant each from India and Tanzania) were not evaluable and not included in the final analyses
  3. bMaternal antiretroviral therapy (ART) with tenofovir, emtricitabine, and ritonavir-boosted lopinavir
  4. ^CD4 count and viral load are from baseline plasma samples
  5. ^Study matching criteria as well as date of randomization