Safety and Effectiveness of 3 Doses of Crofelemer Compared to Placebo in the Treatment of HIV Associated Diarrhea (ADVENT)
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ClinicalTrials.gov Identifier: NCT00547898 |
Recruitment Status
:
Completed
First Posted
: October 23, 2007
Last Update Posted
: December 23, 2011
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Associated Diarrhea | Drug: Crofelemer 125 mg Drug: Crofelemer 250 mg Drug: Crofelemer 500 mg Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 350 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Two-Stage Study to Assess the Efficacy and Safety of 3 Doses of Crofelemer Orally Twice Daily for the Treatment of HIV-Associated Diarrhea |
Study Start Date : | October 2007 |

Arm | Intervention/treatment |
---|---|
Experimental: Placebo |
Drug: Placebo
Placebo
|
Experimental: Crofelemer 125 mg |
Drug: Crofelemer 125 mg
Crofelemer 125 mg
|
Experimental: Crofelemer 250 mg |
Drug: Crofelemer 250 mg
Crofelemer 250 mg
|
Experimental: Crofelemer 500 mg |
Drug: Crofelemer 500 mg
Crofelemer 500 mg
|
- The primary objective is to determine the proportion of HIV-positive subjects experiencing relief of diarrhea with crofelemer compared to placebo during the placebo-controlled treatment phase. [ Time Frame: 31 days ]
- Primary efficacy outcome is two or less watery bowel movements per week during at least two weeks of the treatment phase. [ Time Frame: 31 days ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00547898

Responsible Party: | Valeant Pharmaceuticals International, Inc. |
ClinicalTrials.gov Identifier: | NCT00547898 History of Changes |
Other Study ID Numbers: |
NP303-101 |
First Posted: | October 23, 2007 Key Record Dates |
Last Update Posted: | December 23, 2011 |
Last Verified: | December 2011 |
Keywords provided by Valeant Pharmaceuticals International, Inc.:
HIV AIDS Diarrhea HIV Associated Diarrhea |
Additional relevant MeSH terms:
Diarrhea Signs and Symptoms, Digestive Signs and Symptoms |