HIV Associated Diarrhea
Conditions
Keywords
HIV, AIDS, Diarrhea, HIV Associated Diarrhea
Brief summary
This is a randomized, double-blind, parallel-group, placebo-controlled, multi-center study. This study will compare an investigational new drug (crofelemer) to placebo for the control of HIV-associated diarrhea. The first stage of the study will determine the optimal dose of study drug based on safety and response to therapy and the second stage will evaluate further the effectiveness of the optimal dose.
Interventions
DRUGCrofelemer 125 mg
Crofelemer 125 mg
DRUGCrofelemer 250 mg
Crofelemer 250 mg
DRUGCrofelemer 500 mg
Crofelemer 500 mg
DRUGPlacebo
Placebo
Sponsors
Bausch Health Americas, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* History of HIV-1 infection confirmed by standard serological tests * Stable medical regimen for treatment of HIV disease and associated conditions for at least 4 weeks prior to screening * Patient-reported history of diarrhea, defined as either persistently loose stools despite regular ADM use, or one or more watery bowel movements per day without regular ADM use, of at least 1 month duration * Colonoscopy within the past 5 years if ≥ 50 years of age.
Exclusion criteria
* Pregnancy or breast-feeding * Current or past gastrointestinal (GI) medical or surgical conditions * Use of certain opiate pain medication within 2 weeks of screening * Use of an antibiotic within 2 weeks prior to screening, with the exception of stable antibiotic therapy for prophylactic treatment of infection or an HIV-associated condition * CD4 counts \< 100 cells/mm3 * Previous randomization into this study, or into any other crofelemer study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Efficacy Outcome is Count of Participants With Two or Less Watery Bowel Movements Per Week During at Least Two Weeks of the Treatment Phase of the Optimal Dose of Crofelemer Compared to Placebo | 31 days |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Experiencing Relief of Diarrhea | 31 days | Relief of diarrhea was defined as two or less watery bowel movements per week during at least two weeks of the treatment phase. |
Countries
Puerto Rico, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo: Placebo | 138 |
| Crofelemer 125 mg Crofelemer 125 mg: Crofelemer 125 mg | 136 |
| Crofelemer 250 mg Crofelemer 250 mg: Crofelemer 250 mg | 54 |
| Crofelemer 500 mg Crofelemer 500 mg: Crofelemer 500 mg | 46 |
| Total | 374 |
Baseline characteristics
| Characteristic | Placebo | Crofelemer 125 mg | Crofelemer 250 mg | Crofelemer 500 mg | Total |
|---|---|---|---|---|---|
| Age, Continuous | 44.8 years STANDARD_DEVIATION 8.42 | 45 years STANDARD_DEVIATION 7.66 | 43.8 years STANDARD_DEVIATION 8.37 | 45.8 years STANDARD_DEVIATION 9.06 | 44.9 years STANDARD_DEVIATION 1.59 |
| Sex: Female, Male Female | 22 Participants | 21 Participants | 6 Participants | 7 Participants | 56 Participants |
| Sex: Female, Male Male | 116 Participants | 115 Participants | 48 Participants | 39 Participants | 318 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 137 | 0 / 130 | 0 / 54 | 0 / 42 |
| serious Total, serious adverse events | 4 / 137 | 2 / 130 | 0 / 54 | 0 / 42 |
Outcome results
Primary
Primary Efficacy Outcome is Count of Participants With Two or Less Watery Bowel Movements Per Week During at Least Two Weeks of the Treatment Phase of the Optimal Dose of Crofelemer Compared to Placebo
Time frame: 31 days
Population: The primary efficacy analysis was pre-specified to be for the optimal dose of crofelemer compared to placebo. Crofelemer 125 mg BID group was selected as the optimal dose. Since other doses of crofelemer were not considered to be the optimal dose, they are not included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Crofelemer 125Mg BID | Primary Efficacy Outcome is Count of Participants With Two or Less Watery Bowel Movements Per Week During at Least Two Weeks of the Treatment Phase of the Optimal Dose of Crofelemer Compared to Placebo | 24 Participants |
| Placebo BID | Primary Efficacy Outcome is Count of Participants With Two or Less Watery Bowel Movements Per Week During at Least Two Weeks of the Treatment Phase of the Optimal Dose of Crofelemer Compared to Placebo | 11 Participants |
Other Pre-specified
Percentage of Participants Experiencing Relief of Diarrhea
Relief of diarrhea was defined as two or less watery bowel movements per week during at least two weeks of the treatment phase.
Time frame: 31 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Crofelemer 125Mg BID | Percentage of Participants Experiencing Relief of Diarrhea | 11 Participants |
| Placebo BID | Percentage of Participants Experiencing Relief of Diarrhea | 24 Participants |
| Crofelemer 250 mg | Percentage of Participants Experiencing Relief of Diarrhea | 5 Participants |
| Crofelemer 500 mg | Percentage of Participants Experiencing Relief of Diarrhea | 9 Participants |