Trial · NCT01374490
Safety and Tolerability of Crofelemer for HIV-Associated Diarrhea
NCT01374490, Phase 3, Completed, Bausch Health Americas, Inc.; results first posted 2020-08-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Tolerability of Crofelemer for HIV-Associated Diarrhea. Trials, record NCT01374490. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01374490
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Tolerability of Crofelemer for HIV-Associated Diarrhea
- NCT number
- NCT01374490
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 250 participants, actual
- Lead sponsor
- Bausch Health Americas, Inc.
- Conditions
- HIV Enteropathy, Diarrhea With HIV
- Interventions
- Crofelemer
- First posted
- 2011-06-16
- Last updated
- 2020-08-31
- Results first posted
- 2020-08-17
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs). | 48 weeks |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs). | 48 weeks | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs). | Crofelemer | Any TEAE | 189 | Participants | |
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs). | Crofelemer | Any SAEs | 20 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Crofelemer | 250 | |
| Overall Study | COMPLETED | Crofelemer | 190 | |
| Overall Study | NOT COMPLETED | Crofelemer | 60 |
Source ClinicalTrials.gov
Adverse events35
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Constipation | Gastrointestinal disorders | Crofelemer | 14 | 250 | |
| other | Nausea | Gastrointestinal disorders | Crofelemer | 14 | 250 | |
| other | Upper respiratory tract infection | Infections and infestations | Crofelemer | 42 | 250 | |
| other | Parasitic infection intestinal | Infections and infestations | Crofelemer | 31 | 250 | |
| other | Giardiasis | Infections and infestations | Crofelemer | 20 | 250 | |
| other | Bronchitis | Infections and infestations | Crofelemer | 15 | 250 | |
| other | Blastocystis infection | Infections and infestations | Crofelemer | 13 | 250 | |
| serious | IDIOPATHIC THROMBOCYTOPENIC PURPURA | Blood and lymphatic system disorders | Crofelemer | 1 | 250 | |
| serious | THROMBOCYTOPENIA | Blood and lymphatic system disorders | Crofelemer | 1 | 250 | |
| serious | ANGINA PECTORIS | Cardiac disorders | Crofelemer | 1 | 250 |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Crofelemer | ||
| Total, other adverse events | Crofelemer | 107 | 250 |
| Total, serious adverse events | Crofelemer | 20 | 250 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01374490
GET https://conductscience.org/api/trials/v1/NCT01374490/events?page=2