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. |