Trial Outcomes & Findings for Safety and Tolerability of Crofelemer for HIV-Associated Diarrhea (NCT NCT01374490)
NCT ID: NCT01374490
Last Updated: 2020-08-31
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
250 participants
Primary outcome timeframe
48 weeks
Results posted on
2020-08-31
Participant Flow
Participant milestones
| Measure |
Crofelemer
Crofelemer: Crofelemer will be administered orally as 1 tablet(125 mg)BID for a total daily dose of 250mg crofelemer.
|
|---|---|
|
Overall Study
STARTED
|
250
|
|
Overall Study
COMPLETED
|
190
|
|
Overall Study
NOT COMPLETED
|
60
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Tolerability of Crofelemer for HIV-Associated Diarrhea
Baseline characteristics by cohort
| Measure |
Crofelemer
n=250 Participants
Crofelemer: Crofelemer will be administered orally as 1 tablet(125 mg)BID for a total daily dose of 250mg crofelemer.
|
|---|---|
|
Age, Continuous
|
46.8 years
STANDARD_DEVIATION 8.27 • n=5 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
211 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 48 weeksOutcome measures
| Measure |
Crofelemer
n=250 Participants
Crofelemer: Crofelemer will be administered orally as 1 tablet(125 mg)BID for a total daily dose of 250mg crofelemer.
|
|---|---|
|
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs).
Any TEAE
|
189 Participants
|
|
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs).
Any SAEs
|
20 Participants
|
Adverse Events
Crofelemer
Serious events: 20 serious events
Other events: 107 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Crofelemer
n=250 participants at risk
Crofelemer: Crofelemer will be administered orally as 1 tablet(125 mg)BID for a total daily dose of 250mg crofelemer.
|
|---|---|
|
Blood and lymphatic system disorders
IDIOPATHIC THROMBOCYTOPENIC PURPURA
|
0.40%
1/250 • 48 weeks
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.40%
1/250 • 48 weeks
|
|
Cardiac disorders
ANGINA PECTORIS
|
0.40%
1/250 • 48 weeks
|
|
Gastrointestinal disorders
PANCREATITIS ACUTE
|
0.40%
1/250 • 48 weeks
|
|
General disorders
CHEST DISCOMFORT
|
0.40%
1/250 • 48 weeks
|
|
Infections and infestations
ABSCESS LIMB
|
0.40%
1/250 • 48 weeks
|
|
Infections and infestations
CELLULITIS
|
1.6%
4/250 • 48 weeks
|
|
Infections and infestations
CYTOMEGALOVIRUS CHORIORETINITIS
|
0.40%
1/250 • 48 weeks
|
|
Infections and infestations
GASTROENTERITIS CRYPTOSPORIDIAL
|
0.40%
1/250 • 48 weeks
|
|
Infections and infestations
INFLUENZA
|
0.40%
1/250 • 48 weeks
|
|
Infections and infestations
PNEUMONIA
|
0.40%
1/250 • 48 weeks
|
|
Infections and infestations
SEPSIS
|
0.40%
1/250 • 48 weeks
|
|
Infections and infestations
VIRAL INFECTION
|
0.40%
1/250 • 48 weeks
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
0.40%
1/250 • 48 weeks
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.80%
2/250 • 48 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ANAL CANCER
|
0.40%
1/250 • 48 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLON CANCER
|
0.40%
1/250 • 48 weeks
|
|
Nervous system disorders
CONVULSION
|
0.40%
1/250 • 48 weeks
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
0.40%
1/250 • 48 weeks
|
|
Psychiatric disorders
DEPRESSION
|
0.40%
1/250 • 48 weeks
|
|
Psychiatric disorders
SUICIDE ATTEMPT
|
0.80%
2/250 • 48 weeks
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
0.40%
1/250 • 48 weeks
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.40%
1/250 • 48 weeks
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.40%
1/250 • 48 weeks
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
0.40%
1/250 • 48 weeks
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY MASS
|
0.40%
1/250 • 48 weeks
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.40%
1/250 • 48 weeks
|
|
Vascular disorders
HYPERTENSION
|
0.40%
1/250 • 48 weeks
|
Other adverse events
| Measure |
Crofelemer
n=250 participants at risk
Crofelemer: Crofelemer will be administered orally as 1 tablet(125 mg)BID for a total daily dose of 250mg crofelemer.
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
5.6%
14/250 • 48 weeks
|
|
Gastrointestinal disorders
Nausea
|
5.6%
14/250 • 48 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
16.8%
42/250 • 48 weeks
|
|
Infections and infestations
Parasitic infection intestinal
|
12.4%
31/250 • 48 weeks
|
|
Infections and infestations
Giardiasis
|
8.0%
20/250 • 48 weeks
|
|
Infections and infestations
Bronchitis
|
6.0%
15/250 • 48 weeks
|
|
Infections and infestations
Blastocystis infection
|
5.2%
13/250 • 48 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Contact sponsor directly for details
- Publication restrictions are in place
Restriction type: OTHER