There’s more to life than HIV
Learn more about the Illuminate clinical research studies, evaluating an investigational medication for people living with HIV-1.*The information you provide is completely confidential.
About the Studies
The Illuminate Studies are evaluating the safety, tolerability, and effectiveness of an investigational medication that you take once a day. Currently, a 3-drug combination is the standard of care for treating human immunodeficiency virus (HIV). These studies aim to evaluate the safety and effectiveness of a 2-drug combination therapy.
There are 2 different Illuminate Studies currently enrolling, the Illuminate HTE Study and the Illuminate Naïve Study.
The Illuminate HTE Study is for people with HIV who are heavily treatment experienced (HTE) with multiple HIV medications.
In order to qualify, you:*
- Must have tried several HIV medications
- Are still taking HIV medications
- Have a viral load greater than 500
The Illuminate Naïve Study is for people diagnosed with HIV who have not yet received HIV treatment, or who have received treatment for less than 10 days. Prior PreP use is allowed.
In order to qualify, you must:*
- Be 18 years of age or older
- Have not tried any HIV medication (antiretroviral therapy), or have been on HIV treatment for less than 10 days. (Prior PrEP treatment is permitted.)
Currently on an HIV regimen? Haven’t started treatment? Talk to your doctor about the Illuminate Studies
There is a lot to consider when deciding to participate in an HIV research study. We encourage you to download our informational brochure and talk to your doctor about whether the Illuminate Studies are right for you.Download the PDF
If you qualify and decide to participate:
- Participation is voluntary, and you are free to withdraw at any time.
- Your privacy will be maintained throughout the study
- There is no cost to participate, and you will receive all investigational study medications and study-related doctor visits at no charge
- Travel support will be provided, if needed
- Your HIV and overall health will be closely monitored by an experienced HIV study team
- Your participation may help advance medical knowledge about HIV and may help others
Additional potential risks and benefits of participation will be fully described by your study team.
About HIV Clinical Research
Clinical research studies explore whether a study medication is safe and effective for patients. Clinical research has led to improvements in HIV treatments, allowing people with HIV to live with undetectable levels. The HIV-1 infection has become a chronic, manageable condition. Current antiretroviral therapies have known safety and tolerability issues, which may be improved through clinical research.
Some of the goals of HIV clinical trials are to find medications that:
- Keep HIV at undetectable levels in the blood
- Are safe and effective to take over a long period of time
- Possess a high barrier to viral resistance
- Are easy for patients to fit into their lives – for example, pills that can be taken once a day, with or without food, etc
Qualified doctors, nurses, and other medical professionals are responsible for conducting each clinical trial. Regulatory bodies in each country provide oversight and approval after a thorough review. A study medication will only be approved for use after it is shown to be safe and effective in clinical trials.
About Clinical Research
A clinical research study, also known as a clinical trial, is a scientific study that evaluates the safety and effectiveness of an investigational medication. A clinical research study may show that the investigational medication is better than, as good as, or worse than the standard treatment or inactive placebo (looks like the study medication but contains no active ingredient). Qualified doctors, nurses, and other medical professionals are responsible for conducting the study.
It is only through the completion of clinical research studies that investigational medications can be evaluated and, if proven safe and effective, approved for a particular use. Different regulatory bodies in different countries will provide this approval after a thorough review. Prescription medications in use today were first proven safe and effective during clinical research studies.
In order to ensure that a clinical research study is ethical and that subject rights are protected, Institutional Review Boards (IRB) or Ethics Committees (EC) review study protocols that detail all aspects of how the study is conducted. In addition, study monitors, also known as clinical research associates, visit the study sites to confirm the study protocol procedures and research study requirements and regulations are being followed throughout the study. Health authorities may also inspect the study sites to ensure the safety and rights of the subjects participating in a trial and the integrity of the research study objectives.
Only people who meet all required eligibility criteria for a clinical research study may take part. The study team at the clinic you select will review your medical history and current medical status against the eligibility criteria. They will determine if you are eligible to participate in the study. You may also be asked to provide information from your medical records to help the study team determine whether or not you may be eligible.
An investigational medication is a medication that has not been approved by regulatory or health authorities (eg, the US Food and Drug Administration (FDA), European Medicines Agency (EMA) or appropriate regulatory authorities if studies are Ex-US) for prescription use.
About the Illuminate Studies
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. is the sponsor of these studies.
The purpose of the Illuminate Studies is to evaluate the safety, tolerability, and effectiveness of the investigational medication in patients with HIV-1.
The Illuminate HTE Study lasts about 112 weeks and includes about 17 visits to the study site. The Illuminate Naïve Study lasts about 2 years and includes about 13 visits to the study site. If you qualify and are referred to a study site, the study staff can give you more information about the studies.
Before you agree to participate, the study staff will review all aspects of the study for which you qualify, including required study assessments. If you decide to take part, you will be given a document called an Informed Consent Form that provides, in writing, the study’s purpose, assessments, procedures, benefits, risks, and precautions. You will have the opportunity to ask questions and decide if taking part is right for you.
If you are eligible to participate, the study doctor and research nurse can provide more information and answer your questions.
About The Investigational Medication
The investigational medication is being evaluated to see how well it works and how safe it is in people with HIV-1.
A placebo looks like the investigational medication but is an inactive substance. It is sometimes used in clinical research studies to evaluate the safety and effectiveness of the study treatment. Some of the Illuminate Studies use a placebo that’s taken along with the investigational medication or a drug already approved for use.
Privacy, Stopping Participation, Costs, and Permission
The study team respects and protects your privacy and will not share your information except as required by law and will store your personal information with codes that do not identify you. The Informed Consent Form will provide more information about how your privacy will be maintained.
Your participation in the clinical research study is entirely voluntary and you may withdraw at any time. If you decide to withdraw early, you will be asked to notify the study team before doing so. You will be asked to return to the clinic at least once to complete a final visit and return any unused investigational medication.
There is no charge for taking part. All assessments and investigational medication related to the clinical research study are provided at no charge.
You will not be paid for taking part in the study. The study team can inform you about reimbursement for expenses incurred to attend study visits if you are eligible. Travel support will be provided to participants if needed. The study site can give you more information about how travel support may be arranged.
Your doctor does not have to give permission for you to participate. However, either you or the study doctor, with your permission, may contact your personal doctor to discuss your participation before you begin and keep your doctor up-to-date about your progress.