HIV Associated DiarrheaPhase 3ADVENTNCT00547898

Safety and Effectiveness of 3 Doses of Crofelemer Compared to Placebo in the Treatment of HIV Associated Diarrhea

A Phase 3 study testing Crofelemer 125 mg, Crofelemer 250 mg and Crofelemer 500 mg in people with HIV Associated Diarrhea, run by Bausch Health Americas, Inc. at 82 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV Associated Diarrhea
What is being tested?: Crofelemer 125 mg, Crofelemer 250 mg and Crofelemer 500 mg
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 374 participants
Where: 82 sitesin 2 countries
Study dates: Oct 2007to 11 Jul 2011
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

82 sites in 2 countries.

Country

City, postcode or hospital

82 sites in 2 countries

United States79 sites

Study site
Albuquerque, New Mexico, 87131
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Ann Arbor, Michigan, 48109
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Atlanta, Georgia, 30309
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Atlanta, Georgia, 30318
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Austin, Texas, 78705
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Bakersfield, California, 93301
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Baltimore, Maryland, 21201
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Bellaire, Texas, 77401
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Beverly Hills, California, 90210
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Beverly Hills, California, 90211
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Boston, Massachusetts, 02111
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Chicago, Illinois, 60607
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Chicago, Illinois, 60611
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Chicago, Illinois, 60654
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Cincinnati, Ohio, 45267
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Columbia, South Carolina, 29203
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Dallas, Texas, 75243
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Dallas, Texas, 75246
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Dallas, Texas, 77030
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Daytona Beach, Florida, 32117
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Denver, Colorado, 80205
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Detroit, Michigan, 48201
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Detroit, Michigan, 48202
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Fort Lauderdale, Florida, 33306
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Fort Lauderdale, Florida, 33308
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Fort Lauderdale, Florida, 33316
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Fountain Valley, California, 92708
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Ft. Pierce, Florida, 34982
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Gastonia, North Carolina, 28504
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Great Neck, New York, 11023
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Harlingen, Texas, 78550
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Houston, Texas, 77004
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Houston, Texas, 77030
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Houston, Texas, 77074
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Houston, Texas, 77098
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Huntsville, Alabama, 35801
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Iowa City, Iowa, 52242
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Kansas City, Missouri, 64106
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Kansas City, Missouri, 64111
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Little Rock, Arkansas, 72207
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Long Beach, California, 90813
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Longview, Texas, 75605
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Los Angeles, California, 90015
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Los Angeles, California, 90022
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Los Angeles, California, 90027
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Lynchburg, Virginia, 24501
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Manhasset, New York, 11030
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Miami, Florida, 33133
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Miami, Florida, 33137
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Miami, Florida, 33180
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Miami Beach, Florida, 33139
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Mount Vernon, New York, 10550
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New York, New York, 10010
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New York, New York, 10011
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New York, New York, 10018
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Oakland, California, 94609
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Orlando, Florida, 32803
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Orlando, Florida, 32806
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Palm Springs, California, 92262
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Phoenix, Arizona, 85006
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Portland, Oregon, 97210
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Portland, Oregon, 97219
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Richmond, Virginia, 23219
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Rochester, New York, 14604
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San Antonio, Texas, 78229
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San Antonio, Texas, 78258
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San Diego, California, 92120
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San Francisco, California, 94118
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San Mateo, California, 94403
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Santa Fe, New Mexico, 87505
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Seattle, Washington, 98104
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Spokane, Washington, 99204
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Springfield, Massachusetts, 01107
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St Louis, Missouri, 63108
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Tampa, Florida, 33602
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Tampa, Florida, 33614
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The Bronx, New York, 10461
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West Palm Beach, Florida, 33401
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Wilton Manors, Florida, 33305

Other trials in United States

Puerto Rico3 sites

Study site
Ponce, 00717
Study site
Rio Piedras, 00935
Study site
San Juan, 00909

Other trials in Puerto Rico

About this study

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

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.

Conditions: HIV Associated Diarrhea
Being tested: Crofelemer 125 mg, Crofelemer 250 mg, Crofelemer 500 mg, Placebo
Keywords: HIV, AIDS, Diarrhea, HIV Associated Diarrhea
Medical subject headings: Acquired Immunodeficiency Syndrome, Diarrhea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Crofelemer 125 mgDrug
Crofelemer 125 mg
Crofelemer 250 mgDrug
Crofelemer 250 mg
Crofelemer 500 mgDrug
Crofelemer 500 mg
PlaceboDrug
Placebo

Study groups in NCT00547898
Study group	Role	What they receive
Placebo	Experimental	Not described Receives: Drug: Placebo
Crofelemer 125 mg	Experimental	Not described Receives: Drug: Crofelemer 125 mg
Crofelemer 250 mg	Experimental	Not described Receives: Drug: Crofelemer 250 mg
Crofelemer 500 mg	Experimental	Not described Receives: Drug: Crofelemer 500 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 31 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 200711 Jul 2011

First posted23 Oct 2007 (estimated)
Study startOct 2007
Primary completion27 Jan 2011
Study completion11 Jul 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HIV Associated DiarrheaStudies of the same condition, open and under way.
More trials run by Bausch Health Americas, Inc.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 374 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00547898
Sponsor's protocol ID: NP303-101
Acronym: ADVENT
Status last verified: Aug 2020
First submitted: 21 Oct 2007
Last updated: 3 Sep 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Study at a glance

From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00547898
Acronym / sponsor ID: ADVENT / NP303-101
Conditions: HIV Associated Diarrhea
Keywords: HIV, AIDS, Diarrhea, HIV Associated Diarrhea
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 374 participants (actual)
Lead sponsor: Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
Study start: Oct 2007
Primary completion: 27 Jan 2011 (actual)
Study completion: 11 Jul 2011 (actual)
First posted: 23 Oct 2007 (estimated)
Results: Posted 3 Sep 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Placebo	Experimental	Drug: Placebo
Crofelemer 125 mg	Experimental	Drug: Crofelemer 125 mg
Crofelemer 250 mg	Experimental	Drug: Crofelemer 250 mg
Crofelemer 500 mg	Experimental	Drug: Crofelemer 500 mg

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Crofelemer 125 mgCrofelemer 125 mg	Drug	Crofelemer 125 mg
Crofelemer 250 mgCrofelemer 250 mg	Drug	Crofelemer 250 mg
Crofelemer 500 mgCrofelemer 500 mg	Drug	Crofelemer 500 mg
PlaceboPlacebo	Drug	Placebo

Primary outcome

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

Results and safety

Results posted to the registry on 3 Sep 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	138	129
Crofelemer 125 mg	136	126
Crofelemer 250 mg	54	54
Crofelemer 500 mg	46	40

Primary outcome: 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. Count of participants. Unit: Participants

Measure	Crofelemer 125Mg BID n = 136	Placebo BID n = 138
Value	24	11

Population analysed: 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.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	4 of 137 (2.9%)	0 of 137 (0%)	Not reported
Crofelemer 125 mg	2 of 130 (1.5%)	0 of 130 (0%)	Not reported
Crofelemer 250 mg	0 of 54 (0%)	0 of 54 (0%)	Not reported
Crofelemer 500 mg	0 of 42 (0%)	0 of 42 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

82 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Crofelemer 125 mg, Crofelemer 250 mg and Crofelemer 500 mg in people with HIV Associated Diarrhea, run by Bausch Health Americas, Inc. at 82 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 82 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00547898.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2020.