Clinical Research FAQs

Clinical research studies are conducted to determine if potential new medicines are safe and whether they work. Clinical research studies are performed according to government regulations that help protect the safety and rights of study participants.

A clinical investigator is a medical researcher in charge of conducting a clinical study and ensuring the well-being of study volunteers. The investigators conducting the PURPOSE clinical studies are all qualified licensed doctors and medical specialists.

An investigational drug, or research study drug, is a drug that has not yet been approved by the Food and Drug Administration (FDA), or other regulatory agencies for prescription by doctors. The investigational medicine in the PURPOSE clinical studies is lenacapavir.

Yes, participation in any clinical research study is completely voluntary. If you decide to stop participating at any time, your exit will not affect the medical care you would otherwise receive.

Informed consent is the process of learning the key facts and details about a clinical research study. This information will be provided to you before you decide to participate and as new information becomes available during your continued participation throughout the study. Once you have read the informed consent form and understand the details, including the risks and benefits, you can decide whether to sign the document. The informed consent process also includes opportunities for you to ask questions about the study. No study-related procedures will take place without a signed informed consent form.