Open-label, Follow-up of Doravirine/Islatravir (DOR/ISL 100 mg/0.75mg) for Participants With Human Immunodeficiency Virus-1 (HIV-1) Infection (MK-8591A-033)
This study is a follow-up for people living with HIV-1 who have been taking a new two-drug tablet, MK-8591A (which contains doravirine and islatravir), in earlier clinical trials. The main aim is to continue checking how safe the medicine is and how well people tolerate it over a longer period. Participants will have the option to keep taking MK-8591A for an extended time, up to five and a half years, if their doctor believes it is still helping them. This continuation allows researchers to gather more information on the long-term effects of this combination treatment for HIV-1.
At a glance
What is this study about?
This study is looking at an anti-HIV medicine called MK-8591A. It's a special tablet that contains two different drugs, doravirine and islatravir, combined into one. This particular study is a "follow-up," which means it's for people who have already been taking MK-8591A in previous research studies.
The main goal is to keep learning about how safe this medicine is and how well people tolerate it over a longer period. By letting participants continue to take the drug, researchers can get a better understanding of its long-term effects and benefits for people living with HIV-1.
Participants can choose to keep receiving MK-8591A for quite a long time – up to nearly six years – as long as their study doctor thinks it's still good for them. This helps ensure that patients who are benefiting from the treatment can continue to receive it while also providing valuable information for future HIV treatments.
Key takeaways
- This is a follow-up study for people with HIV-1 already on MK-8591A.
- The study aims to check the long-term safety and tolerability of the medicine.
- Participants can continue taking MK-8591A for up to 5.5 years if beneficial.
- Your study doctor must agree that the medicine is appropriate for you.
- Strict rules apply for women of childbearing potential.
Who may be eligible?
To be able to join this study, you must already be taking the MK-8591A tablet in another study supported by the manufacturer, MSD, and have completed your last visit for that earlier study.
Your study doctor must also believe that the MK-8591A tablet is helping you and is a suitable treatment for you to continue taking. For women, you must not be pregnant or breastfeeding. If you are a woman who could become pregnant, you must either not be sexually active or agree to use effective contraception (birth control) during the study and for at least 6 weeks afterwards.
- Are you currently taking the MK-8591A tablet in another study sponsored by MSD?
- Have you completed the last visit of that previous study?
- Does your study doctor think the MK-8591A is helping you and is a good treatment for you to continue?
- If you are a woman, are you not pregnant or breastfeeding?
- If you are a woman who could become pregnant, are you using effective contraception or not sexually active?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you are eligible, taking part means you will continue to receive the MK-8591A tablet as you have been doing. You will keep attending regular appointments at the study clinic, where the study team will monitor your health and how you are responding to the medication. These visits will likely include blood tests and other routine checks to assess the safety and effectiveness of the treatment. The total duration of your participation could be quite long – up to 288 weeks, or about five and a half years, depending on your individual health and the decision of your study doctor.
Potential risks and benefits
Locations (93)
- Pueblo Family Physicians ( Site 0010)Phoenix, United States
- One Community Health ( Site 0045)Sacramento, United States
- Whitman-Walker Institute ( Site 0039)Washington D.C., United States
- Georgetown University Medical Center-Clinical Trials Unit Division of Infectious Diseases ( Site 002Washington D.C., United States
- Midway Immunology and Research Center ( Site 0033)Ft. Pierce, United States
- Orlando Immunology Center ( Site 0017)Orlando, United States
- Bliss Healthcare Services-Research ( Site 0030)Orlando, United States
- Triple O Research Institute, P.A ( Site 0031)West Palm Beach, United States
- Chatham County Health Department - Chatham CARE Center-Infectious Disease ( Site 0015)Savannah, United States
- Northstar Healthcare ( Site 0003)Chicago, United States
- KC CARE Health Center-Clinical Trials ( Site 0012)Kansas City, United States
- ID Care ( Site 0028)Hillsborough, United States
+81 more sites — see the official record for the full list.
Common questions
What is the main purpose of this study?
The main purpose is to keep checking the safety and how well people tolerate the MK-8591A medicine over a longer period in people who are already taking it for HIV-1.
Who can join this study?
You can join if you're already taking the MK-8591A tablet in an earlier study and your doctor thinks it's still good for you. There are also specific requirements for women related to pregnancy.
How long will I be in the study if I join?
You could be in the study for a long time, potentially up to 288 weeks (about five and a half years), as long as your doctor believes the medicine is still helping you.
Will I get new medicine in this study?
No, this study is about continuing to take the MK-8591A tablet that you have already been receiving in a previous study.
What if I want to stop taking part?
You can choose to leave the study at any time, for any reason, and it won't affect your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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