- The study compound is a new compound that may potentially be used for the treatment of HIV. Approximately 40 million people are currently living with HIV/AIDS worldwide. HIV is a virus that affects the immune system, especially the cells that help the body fight infections. In the case of infections, viruses, bacteria, fungi or parasites (so-called 'pathogens') enter the body and start to grow. If the immune system is strong enough, such a pathogen is less likely to cause an infection. But, if the immune system is weakened, the body can no longer protect itself properly and someone becomes ill. If someone is not treated for HIV, this person can therefore become more susceptible to diseases.
- The study compound has been administered to humans before. In addition, it has been extensively tested in the laboratory and on animals.
- In group 1 you will receive the study compound once as a cloudy drink. In addition, you will receive the study compound once via an infusion directly into the blood vessel, which will take approximately one hour.
- In group 2 you will receive the study compound once as a cloudy drink.
- Only for group 1: On the day of the administration, you will swallow a capsule on a thread to collect fluid from your small intestine. Before swallowing, the end of the string is secured to your cheek with a plaster. Stomach action then moves the capsule and thread into the small intestine where the capsule dissolves. The thread remains there to absorb bile and intestinal fluid. The thread will be removed a few hours after you have swallowed the capsule.
- This is a clinical trial with a radioactive (14C) labeled compound. Radioactively labeling a compound is done to be able to study how quickly and to what extent the compound is absorbed, converted and excreted by the body. The radioactivity disappears from the body at the same time as the compound through the feces, urine and/or breath. The compound has a radiation burden which is less than from the natural background radiation that you are exposed to in the Netherlands in 1 month. This background radiation is released from space, soil, air, water, food and construction materials. To measure radioactivity levels in your body, blood, urine and feces will be collected during the trial.
In previous studies, 277 participants (including 20 participants with HIV) have taken the study compound, as single or multiple doses. Overall, there have been no safety problems of concern. Potential side effects include:
- a very small amount of the study compound may seep into the tissue around the injection site. This can cause pain, swelling and redness at that site.
- hypersensitivity (severe allergic reactions).
You may also experience other, yet unknown, side effects. Prior to the medical screening, you will receive written information about the trial, which also describes the possible side effects. This information will also be discussed with you at the start of the medical screening. You can then ask the screening physician or nurse any questions you may have. Once everything is clear to you, you can decide whether to give written consent to participate in the trial. The medical screening will only take place after you have given written consent to participate in the trial. We want to emphasize that even after giving written consent, participation in any clinical trial is voluntary. You can decide at any time not to participate or to stop the medical screening or the trial. You do not need to provide a reason for why you no longer wish to participate.
You are only allowed to drink water in the 8 hours before the start of the screening. This means that, prior to your potential participation in the study, we will ask you to refrain from eating for a certain period of time. You have not yet signed the form for participation in the trial. After the screening it will be announced whether you can participate.
