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

August 19, 2020 updated by: Bausch Health Americas, Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
374

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Ponce, Puerto Rico, 00717
      • Rio Piedras, Puerto Rico, 00935
      • San Juan, Puerto Rico, 00909
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
    • Arizona
      • Phoenix, Arizona, United States, 85006
    • Arkansas
      • Little Rock, Arkansas, United States, 72207
    • California
      • Bakersfield, California, United States, 93301
      • Beverly Hills, California, United States, 90211
      • Beverly Hills, California, United States, 90210
      • Fountain Valley, California, United States, 92708
      • Long Beach, California, United States, 90813
      • Los Angeles, California, United States, 90027
      • Los Angeles, California, United States, 90015
      • Los Angeles, California, United States, 90022
      • Oakland, California, United States, 94609
      • Palm Springs, California, United States, 92262
      • San Diego, California, United States, 92120
      • San Francisco, California, United States, 94118
      • San Mateo, California, United States, 94403
    • Colorado
      • Denver, Colorado, United States, 80205
    • Florida
      • Daytona Beach, Florida, United States, 32117
      • Fort Lauderdale, Florida, United States, 33308
      • Fort Lauderdale, Florida, United States, 33316
      • Fort Lauderdale, Florida, United States, 33306
      • Fort Pierce, Florida, United States, 34982
      • Miami, Florida, United States, 33137
      • Miami, Florida, United States, 33133
      • Miami, Florida, United States, 33180
      • Miami Beach, Florida, United States, 33139
      • Orlando, Florida, United States, 32806
      • Orlando, Florida, United States, 32803
      • Tampa, Florida, United States, 33614
      • Tampa, Florida, United States, 33602
      • West Palm Beach, Florida, United States, 33401
      • Wilton Manors, Florida, United States, 33305
    • Georgia
      • Atlanta, Georgia, United States, 30309
      • Atlanta, Georgia, United States, 30318
    • Illinois
      • Chicago, Illinois, United States, 60611
      • Chicago, Illinois, United States, 60654
      • Chicago, Illinois, United States, 60607
    • Iowa
      • Iowa City, Iowa, United States, 52242
    • Maryland
      • Baltimore, Maryland, United States, 21201
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
      • Springfield, Massachusetts, United States, 01107
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
      • Detroit, Michigan, United States, 48201
      • Detroit, Michigan, United States, 48202
    • Missouri
      • Kansas City, Missouri, United States, 64111
      • Kansas City, Missouri, United States, 64106
      • Saint Louis, Missouri, United States, 63108
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
      • Santa Fe, New Mexico, United States, 87505
    • New York
      • Bronx, New York, United States, 10461
      • Great Neck, New York, United States, 11023
      • Manhasset, New York, United States, 11030
      • Mount Vernon, New York, United States, 10550
      • New York, New York, United States, 10011
      • New York, New York, United States, 10010
      • New York, New York, United States, 10018
      • Rochester, New York, United States, 14604
    • North Carolina
      • Gastonia, North Carolina, United States, 28504
    • Ohio
      • Cincinnati, Ohio, United States, 45267
    • Oregon
      • Portland, Oregon, United States, 97210
      • Portland, Oregon, United States, 97219
    • South Carolina
      • Columbia, South Carolina, United States, 29203
    • Texas
      • Austin, Texas, United States, 78705
      • Bellaire, Texas, United States, 77401
      • Dallas, Texas, United States, 75246
      • Dallas, Texas, United States, 75243
      • Dallas, Texas, United States, 77030
      • Harlingen, Texas, United States, 78550
      • Houston, Texas, United States, 77030
      • Houston, Texas, United States, 77004
      • Houston, Texas, United States, 77074
      • Houston, Texas, United States, 77098
      • Longview, Texas, United States, 75605
      • San Antonio, Texas, United States, 78229
      • San Antonio, Texas, United States, 78258
    • Virginia
      • Lynchburg, Virginia, United States, 24501
      • Richmond, Virginia, United States, 23219
    • Washington
      • Seattle, Washington, United States, 98104
      • Spokane, Washington, United States, 99204

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome 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
Time Frame: 31 days
31 days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Experiencing Relief of Diarrhea
Time Frame: 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.
31 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bausch Health Americas, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 27, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 11, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 21, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 22, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 23, 2007

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 3, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NP303-101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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