iod. In the second stage, patients that received placebo were treated with crofelemer 125 mg twice daily in the placebo-free period.
The median time since diagnosis of HIV was 12 years. The percentage of patients with a CD4 cell count of less than 404 was 39%. The percentage of patients with a HIV viral load greater than or equal to 1000, 400 to 999, and less than 400 HIV copies/mL was 7%, 3%, and 9%, respectively; the remainder had a viral load that was not detectable. The median time since diarrhea started was 4 years. The median number of daily watery bowel movements was 2.5 per day.
Most patients were male (85%). The percentage of patients that were Caucasian was 46%; the percentage of patients that were African-American was 32%. The median age was 45 years with a range of 21 to 68 years.
In the double-blind period of the study, 136 patients received crofelemer 125 mg twice daily, 54 patients received 250 mg twice daily, 47 patients received 500 mg twice daily, and 138 patients received placebo. The percentages of patients that completed the double-blind period were 92%, 100%, 85%, and 94% in the 125 mg, 250 mg, 500 mg, and placebo arms, respectively.
Most patients received concomitant protease inhibitors (PI) during the double-blind period (Table 2). The most frequently used ARTs in each group were tenofovir/emtricitabine, ritonavir, and lopinavir/ritonavir.
Table 2: Concomitant ART Use in the Double-Blind Period
|
125 mg BID
(N = 136)
n (%)
|
250 mg BID
(N = 54)
n (%)
|
500 mg BID
(N = 46)
n (%)
|
Placebo BID
(N = 138)
n (%)
|
|
Any ART
|
135 (99)
|
53 (98)
|
45 (98)
|
134 (97)
|
|
Any PI
|
87 (64)
|
41 (76)
|
33 (72)
|
97 (70)
|
|
Tenofovir/Emtricitabine
|
45 (33)
|
22 (41)
|
16 (35)
|
52 (38)
|
|
Ritonavir
|
46 (34)
|
18 (33)
|
15 (33)
|
49 (36)
|
|
Lopinavir/Ritonavir
|
30 (22)
|
21 (39)
|
15 (33)
|
40 (29)
|
|
Efavirenz/Tenofovir/ Emtricitabine
|
30 (22)
|
7 (13)
|
7 (15)
|
21 (15)
|
|
Tenofovir disoproxil fumarate
|
18 (13)
|
8 (15)
|
5 (11)
|
14 (10)
|
|
Atazanavir sulfate
|
19 (14)
|
3 (6)
|
6 (13)
|
22 (16)
|
|
Abacavir w/ lamivudine
|
17 (13)
|
5 (9)
|
5 (11)
|
18 (13)
|
|
Darunavir
|
|
