Consider joining a clinical trial that's evaluating a potential treatment for HIV with once-weekly dosing. During the trial, you will get the support of a clinical trial team at no cost and may be reimbursed for study-related travel costs to trial visits.
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What is HIV?1
HIV is a virus that attacks your immune system (the part of your body that fights off infections and other diseases) and makes it weaker. Without treatment, HIV can turn into AIDS, where your immune system is badly damaged.
Fortunately, medicine can help. It can stop HIV from getting worse or progressing to AIDS. So, the sooner you start it, the better.
When HIV medicine is taken as prescribed, it can lower the amount of HIV in your body to the point that is considered “undetectable”. When you maintain such low levels of virus in your body:
- You are more likely to stay healthy while living with HIV
- The HIV in your body can't be spread to other people through sex
About the WONDERS 2 HIV clinical trial
The WONDERS 2 clinical trial is for people who have never been on an HIV treatment. It is looking at whether an investigational once-weekly HIV treatment works as well as a currently available single tablet, daily medicine (bictegravir, emtricitabine & tenofovir alafenamide). It is also looking at whether people have side effects, and which ones, while taking the weekly HIV pill.
Right now, the once-weekly treatment for HIV isn’t an option outside of a clinical trial and is not approved for the treatment of HIV or any other conditions. The findings of the WONDERS 2 clinical trial may help with its development. By joining this clinical trial, you could help contribute to important research about HIV.
Why participate?
If you qualify and decide to join, you will receive the following during the trial at no cost:
- Access to the clinical trial team for support
- The study drug or a currently available single tablet, daily medicine (bictegravir, emtricitabine & tenofovir alafenamide)
You may also be reimbursed for study-related travel costs to trial visits.
In addition, joining a clinical trial may:
- Help others with HIV, both now and in the future
- Help researchers learn about this investigational treatment and HIV
Do I qualify?
You may be eligible to participate in the WONDERS 2 clinical trial if you:
- Are at least 18 years old
- Have never taken an HIV medicine since being diagnosed
- It’s ok if you were on PrEP or PEP prior to your diagnosis
Frequently Asked Questions
About WONDERS 2
Where will I go to participate in WONDERS 2?
WONDERS 2 will be conducted at many locations throughout the US. When you take the pre-screener, we will use your zip code to locate a trial site in your area.
What if I don’t qualify to participate?
If you don’t qualify due to not meeting the trial criteria, the onsite study team may make recommendations about the next steps to take.
How is my personal information protected?
As with all medical records, participant privacy and confidentiality in trials are protected by law. Once the consent form is signed, you will be given a trial code. Your trial records will not include your name or personal identity but will identify you with a trial code. This code can only be tracked back to you via a code key which is held by the responsible physician. Your name or personal identity will never be disclosed.
Who is the clinical trial sponsor?
Gilead Sciences is conducting the WONDERS 2 clinical trial. Gilead Sciences, a leading innovator in the field of HIV, is a biopharmaceutical company that is headquartered in Foster City, California.
What is the time commitment?
The time commitment may vary. During the consent process before enrolling, the research team will explain the specifics about the time commitment that would be required.
Can I withdraw from WONDERS 2?
Yes, participation is voluntary and you may withdraw from a clinical trial at any time.
What does it mean if I provide “informed consent”?
Your written informed consent is required before being enrolled in WONDERS 2. This means you have been provided all relevant information about the study design, how you will participate, your right to withdraw at any time, study alternatives, your personal data protection and the associated risks and benefits, and have had the opportunity to ask any questions and agree to participate. Informed consent is designed to protect your safety and privacy.
Am I allowed to visit my usual healthcare provider when enrolled in WONDERS 2?
Participants are always welcome to visit their usual healthcare providers during a trial. Sometimes, it is important for healthcare providers to collaborate with the research team to ensure success.
Who is on the clinical trial team?
There are a wide variety of professionals involved with any clinical trial, all of whom are vital to ensuring safety and success. The principal investigator, or PI, leads the trial and directs the team of doctors, nurses, and other healthcare workers. The clinical trial coordinator manages day-to-day activities and is the main contact for participants. Many clinical trials also have an independent Data and Safety Monitoring Board (DSMB) who periodically reviews data to ensure participant safety, and sometimes effectiveness.
About Clinical Trials
What is a clinical trial?
Clinical trials answer questions about how well a treatment or therapy works and/or how safe it is by monitoring its effect on people (often through bloodwork and other tests, as well as checking for symptoms and side effects). The people in clinical trials are called clinical trial participants and are volunteers who may be healthy or have a specific illness or condition.
Why do we need clinical trials?
Clinical trials are used to determine the safety data and effectiveness of an investigational treatment. The treatment can be a drug, vaccine, medical device, medical procedure, and/or behavioral intervention. Before treatments can be used by the general public, they must undergo a series of clinical trials, called phases, and be approved by regulatory agencies (such as the FDA in the United States and the European Medicines Agency [EMA] in Europe).
Do participants learn the results of their clinical trial?
After your participation ends, the study may continue for months or years. Once final results from all participants are compiled and analyzed, they are often published publicly. Clinical study report (CSR) synopses and plain language summaries (PLSs) may be made available for certain studies. Check with your clinical trial site or send an email to [email protected] to learn more.
Reference: 1. U.S. Department of Health & Human Services. What are HIV and AIDS? Updated January 13, 2023. Accessed September 24, 2024. https://www.hiv.gov/hiv-basics/overview/about-hiv-and-aids/what-are-hiv-and-aids