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Table 2 Baseline characteristics of ISS T-002 subjects pre- and post-protocol amendment and ISS OBS T-002 subjects

From: HIV-1 Tat immunization restores immune homeostasis and attacks the HAART-resistant blood HIV DNA: results of a randomized phase II exploratory clinical trial

 

ISS T-002 pre-amendment

ISS T-002 post-amendment

ISS OBS T-002

OBS vs pre-amendment T-002

OBS vs post-amendment T-002

( n  = 87)

( n  = 81)

( n  = 79)

p-value b

p-value b

Age

     

Mean ± s.d.a

41 ± 7

42 ± 7

42 ± 6

0.2963

0.8043

Range

26-54

23-55

24-55

  

Gender

     

Male

78%

86%

75%

0.5977

0.0604

Female

22%

14%

25%

  

CD4 + nadir (cells/μl)

     

Mean ± s.d.

352 ± 114

251 ± 131

219 ± 140

<0.0001

0.1131

Range

252-846

14-585

2-612

  

CD4 + (cells/μl)

     

Mean ± s.d.

693 ± 210

585 ± 215

657 ± 271

0.4018

0.0668

Range

425-1490

144-1250

208-1527

  

CD4 + (%)

     

Mean ± s.d.

34 ± 7

32 ± 8

31 ± 8

0.0033

0.2596

Range

19-53

14-61

12-52

  

Years from diagnosis of HIV

     

Mean ± s.d.

9 ± 6

9 ± 7

11 ± 7

0.1583

0.3703

Range

1-23

1-25

1-24

  

Years from HAART initiation

     

Mean ± s.d.

6 ± 4

7 ± 5

6 ± 5

0.2552

0.9073

Range

0-19

0-19

0-19

  

Current HAART regimen

     

NNRTI-based or NRTI

75%

56%

62%

0.0784

0.3434

PI-based

25%

44%

38%

  
  1. n indicates the number of individuals; aStandard deviation; b t-test was applied for continuous variables, Chi-square test was applied for categorical variables.