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
19 (14)
4 (7)
4 (9)
14 (10)
Raltegravir
16 (12)
4 (7)
5 (11)
11 (8)
Valaciclovir hydrochloride
12 (9)
8 (15)
5 (11)
16 (12)
Fosamprenavir
12 (9)
6 (11)
4 (9)
13 (9)
Zidovudine w/ lamivudine
12 (9)
3 (6)
3 (7)
15 (11)
Lamivudine
7 (5)
6 (11)
4 (9)
6 (4)
Nevirapine
8 (6)
6 (11)
3 (7)
9 (7)
Atazanavir
5 (4)
6 (11)
2 (4)
2 (1)
Abbreviations: ART = antiretroviral therapy; PI = Protease Inhibitor; BID = twice daily.
The primary efficacy endpoint was the proportion of patients with a clinical response, defined as less than or equal to 2 watery bowel movements per week during at least 2 of the 4 weeks of the placebo-controlled phase. Patients who received concomitant ADMs or opiates were cou
