Illuminate HTE Study

The Illuminate HTE study is evaluating the safety, tolerability and effectiveness of an investigational medication for people whose viral levels are no longer suppressed after trying several HIV treatments. It is a combination of an investigational medication and another medication that is already approved for use. Currently, a 3-drug combination is the standard for treating human immunodeficiency virus (HIV). This study aims to evaluate the safety and effectiveness of a 2-drug combination therapy taken once a day.

This clinical trial is sponsored by Merck, Sharpe & Dohme (Australia) Pty Ltd (MSD), a subsidiary of Merck & Co Inc, Kenilworth, NJ, USA. NAPWHA is providing information about this important clinical study to our communities because of the potential benefits (ANZCTR Trial ID: NCT04233216).

Any contact details of your enquiry submitted via the webform below will kept confidential. Read more about the NAPWHA Privacy Policy

To find out more, including the possible risks and benefits of participation, and to see if you may qualify, submit your details in the form below. You will be contacted back within 48 hours and provided with the contact details of a research nurse at your nearest participating centre.  Should the form not be displaying below, click here:  https://forms.office.com/r/sq37zWmVRk

This study lasts about 26 months and includes up to 17 visits to the study doctor’s office. The study is being conducted in four sites with the following:

1. Holdsworth House Medical Practice – Sydney, NSW
2. St Vincent’s Hospital – Sydney, NSW
3. The Alfred Hospital – Melbourne, Victoria
4. Holdsworth House Medical Practice – Brisbane, Queensland
5. Monash Health – Monash Medical Centre – Clayton, Victoria

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 medication and study-related doctor visits for the length of your participation at no charge.
• 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 help others.
• The additional potential risks and benefits of participation will be fully described to you by your study team.

Clinical research studies explore the safety and efficacy of the study medication for patients. Clinical research has led to improvements in HIV treatments, allowing people with HIV to live with undetectable levels. HIV-1 infection has become a chronic, manageable condition. Current anti-retroviral 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
• 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.