Patient
Randomization
Number

Cohort

Dose
mg/kg

Age
(years)

Gender

DLT

Adverse Events

Day -1 HIV-Load in logs

Day +7 HIV Load In logs

Log Reduction

6

1

0/PCB

31

M

None

Odinophagia, Cough, Dysuria
(CTC1, NR for all)

36403 (4.6)

46146 (4.7)

-0.1

10

2

0/PCB

44

M

None

Dizziness (CTC1, NR)

4280 (3.6)

11489 (4.1)

-0.5

16

3

0/PCB

30

M

None

Headache, OM (CTC1, NR for all)

70961 (4.9)

98908 (5.0)

-0.1

23

4

0/PCB

37

M

None

Soft tissue infection (CTC 2, NR)

31250 (4.5)

65556 (4.8)

-0.3

27

5

0/PCB

41

M

None

Vomiting (CTC1, NR)

>100000(>5.0)

>100000(>5.0)

ND

1

1

5

39

M

None

Tooth ache (CTC1, NR)

2369 (3.4)

5182 (3.7)

 -0.3

2

1

5

30

M

None

None

3601 (3.6)

5393 (3.7)

-0.1

3

1

5

38

M

None

None

6820 (3.8)

10416 (4.0)

-0.2

4

1

5

42

F

None

None

9379 (4.0)

81221 (4.9)

-0.9

5

1

5

36

F

None

Headache (CTC1, NR)

5264 (3.7)

7599 (3.9)

-0.2

7*

2

10

29

M

None

Scabies, N/V (CTC1, NR for all)

>100000 (>5.0)

65933 (4.8)

>0.2

8

2

10

30

M

None

None

40425 (4.6)

37196 (4.6)

0.0

9

2

10

28

M

None

None

6771 (3.8)

69059 (4.8)

-1.0

11

2

10

41

M

None

None

25687 (4.4)

>100000 (>5.0)

<-0.6

12

2

10

23

M

None

Headache (CTC1, UNL R)

65366 (4.8)

>100000 (>5.0)

<-0.2

13

3

15

25

F

None

Gingivitis, Throat pain, Fever
(CTC1, NR for all)

45462 (4.7)

48402 (4.7)

0.0

14

3

15

30

M

None

Headache, Nausea
(CTC1, NR for all)

19207 (4.3)

46207 (4.7)

-0.4

15*

3

15

31

F

None

None

71108 (4.9)

34011 (4.5)

0.4

17*

3

15

42

M

None

Nasal congestion, cough, tooth ache, headache (CTC1, NR for all)

12169 (4.1)

6135 (3.8)

0.3

18*

3

15

34

M

None

None

>100000(>5.0)

81576(4.9)

>0.1

19

4

20

35

M

None

None

23380 (4.4)

23660 (4.4)

0.0

20

4

20

34

M

None

Diarrhea, Abdominal pain
(CTC1, NR for all)

47932 (4.7)

>100000 (>5.0)

<-0.3

21*

4

20

33

M

None

None

6789 (3.8)

2418 (3.4)

0.4

22*

4

20

45

M

None

Tooth ache (CTC1, NR);
Headache (CTC1, Pos R)

7473 (3.9)

3714 (3.6)

0.3

24

4

20

37

M

None

Nausea (CTC1, UNL R);
Diarrhea (CTC1, NR)

74012 (4.9)

>100000 (>5.0)

<-0.1

25

5

25

40

F

None

None

16440 (4.2)

17366 (4.2)

0.0

26

5

25

32

M

None

Night sweats (CTC1, NR);
Diarrhea (CTC1, Prob R)

47857 (4.7)

40419 (4.6)

0.1

28*

5

25

38

M

None

Headache (CTC1, NR)

41058 (4.6)

30973 (4.5)

0.12

29*

5

25

32

M

None

None

40634 (4.6)

17081 (4.2)

0.4

30*

5

25

42

F

None

Diarrhea (CTC1, Prob R)

8482 (3.9)

4026 (3.6)

0.3

CTC, common terminology criteria for toxicity grading (ctep.cancer.gov/reporting/ctc.html).
UNL, unlikely to be related; Prob. R, probably related; Pos R, possibly related; NR, not related. OM, otitis media;
N/V, nausea and vomiting. * >0.1 logs reduction of the HIV burden.
Table 3: Characteristics and Treatment Response of Patients Enrolled in The First-In-Human Placebo-Controlled Phase I Clinical Trial of Stampidine.