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Therapeutic Areas: Immunology/Infectious Diseases
Disease Category: HIV

Trial Information

HIV-Associated Diarrhea

At last you can take action for HIV-Associated Diarrhea

Sidelined by diarrhea? Approximately half of HIV/AIDS patients may experience diarrhea. Chronic diarrhea may have a significant impact on your quality of life but it can also affect your treatment. Severe diarrhea could lead to your doctor switching you to another antiretroviral treatment, reducing your future treatment options. If diarrhea causes you to skip doses of your antiretroviral treatment this can lead to less effective therapy and possibly promote antiretroviral therapy resistance.

We are currently recruiting patients to take part in a clinical study. In this study, we are testing an investigational medicine that may help control HIV-associated diarrhea and get you back in the game.

Why is controlling diarrhea so important?
Approximately half of HIV/AIDS patients will experience diarrhea. Chronic diarrhea can have a negative impact on your quality of life, but it can also affect your treatment. Severe diarrhea can reduce the absorption of antiretroviral medications into the body, which may decrease the efficacy of antiretroviral therapy and possibly promote antiretroviral resistance. This may lead to your doctor switching you to another antiretroviral medication, reducing your future treatment options.

In this study, researchers are looking to see if an investigational medicine can help control HIV associated diarrhea.

What is a clinical research study?
Clinical research studies are medical research studies designed to answer specific questions about the safety and/or effectiveness of investigational drugs or vaccines. They may also look at new ways of using existing treatments. Carefully conducted clinical studies are the fastest and safest way to help find treatments that work.

What is Crofelemer?
Crofelemer is the investigational medicine being tested in this study. It comes from a common tree found in South America that has been widely used within those cultures for its medicinal properties, including the treatment of diarrhea.

The efficacy and safety of crofelemer has been evaluated in 15 clinical studies, involving approximately 1,250 individuals, across various diarrhea states including HIV-associated diarrhea, acute infectious diarrhea (cholera, others), traveler’s diarrhea (non-specific diarrhea), and diarrhea-predominant Irritable Bowel Syndrome (d-IBS).

What will happen if I take part in this study?
During this study you will be seen as an outpatient. At your first visit, the study doctor will make sure you are eligible to participate. You will be asked to call into a telephone diary daily to answer a series of brief question regarding your symptoms. If you are enrolled, you will continue to call into the diary and also required to come to the clinic for 8 more visits over the next 28 weeks to receive your study medication and study-related assessments. During the trial, you will receive your study medicines at no cost to you, and your health will be closely monitored by the study team. You may also be reimbursed for certain expenses connected to attending your clinic visits.

How will I be given the study treatment?
This is a two-part study (Stage 1 and Stage 2) both comprised of a similar treatment phase and an extension phase.

If you join the study during Stage 1 during the treatment phase, you will be placed into one of four different groups. Three groups will get the investigational treatment for 31 days, while the fourth group will receive a placebo (a sugar tablet that contains no active drug). During the extension phase all patients will receive the investigational treatment crofelemer for up to 20 additional weeks. Meaning that if you are in the group receiving placebo during the treatment phase, you will start receiving active drug in the extension phase. If you are on active drug during the treatment phase, you will remain on active drug during the extension phase.

If you join the study during Stage 2, you will be divided into two different groups for 31 days of treatment. Just like in Stage 1 of the treatment phase, one group will receive placebo the other group will receive active drug. If you are on placebo during the treatment phase, you will start receiving active drug in the extension phase.

Thank you for your interest in the ADVENT study.

Please call us at 1-619-287-6000
San Diego Clinical Trials

Patient Inclusion Criteria:

• Diagnosed with HIV
• Diarrhea
• 18 Years Old

Patient Exclusion Criteria:

• Not on HIV Medication

Trish, Study Coordinator
San Diego Clinical Trials
6719 Alvarado Road #201
San Diego, CA 92120
Phone: 6192876000
Fax: 6192876001
EMail: tristacamccray@sdclinicaltrials.com

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