Active not recruitingPHASE3INTERVENTIONAL

A Study of Doravirine/Islatravir (DOR/ISL, MK-8591A) for the Treatment of Human Immunodeficiency Virus 1 (HIV-1) Infection in Participants Who Previously Received DOR/ISL (MK-8591A-054)

This research study is looking into the long-term safety and how well people tolerate a combination medicine called DOR/ISL. This medicine is for adults living with HIV-1. You can take part in this study if you've previously taken DOR/ISL in other related research studies. The researchers want to continue to understand if this treatment is safe and if people can continue to take it without significant problems. There isn't a specific new treatment being tested here; instead, it's about checking on the people already using this particular medication combination. The study aims to gather more information to help doctors and patients understand the benefits and any potential side effects of DOR/ISL.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

641

Start

17 Mar 2023

Estimated completion

06 Sep 2028

HIV Infection

What is this study about?

This research study is about a medication called DOR/ISL, which is used to treat HIV-1. HIV-1 is a virus that attacks the body's immune system. Medicines like DOR/ISL help to keep the virus under control, allowing people with HIV to lead healthier lives.

This isn't a study where they are trying a completely new drug for the first time. Instead, it's for adults who are already taking DOR/ISL as part of other research studies. The main reason for this study is to keep a close eye on people taking this medicine to make sure it's safe and that they continue to tolerate it well over a longer period. Researchers want to collect more information about the treatment's safety and any side effects that might appear over time.

By taking part, you would be helping researchers learn more about DOR/ISL. This information is really important because it helps improve our understanding of HIV treatments and can help doctors decide the best care for people living with HIV in the future. There are no particular new questions or comparisons being made in this study; it's simply to continue monitoring the safety and how patients cope with the treatment they are already receiving.

Key takeaways

This study is for adults over 18 living with HIV-1.
It's about continuing to monitor the safety of a medicine called DOR/ISL.
You must already be taking DOR/ISL in specific previous research studies to join.
Regular health checks and blood tests will be part of taking part.
You can withdraw from the study at any time.
Your participation helps to improve understanding of HIV treatments.

Who may be eligible?

To join this study, you must already be taking the combination medicine DOR/ISL as part of specific earlier research studies sponsored by a company called Merck Sharp & Dohme (MSD). These specific studies are known by their codes: MK-8591A-018, -020, or -033. If you were in study -033 because you'd had many previous HIV treatments (often called 'heavily treatment-experienced'), you might not be suitable for this particular study.

You cannot join if recent blood tests showed a high level of the HIV-1 virus (200 copies/mL or more) while you were on the DOR/ISL medicine in the previous studies. Also, if your previous study results showed very low levels of certain immune cells (CD4+ T-cells or lymphocytes) which led to you stopping DOR/ISL, you wouldn't be able to join this study.

Essentially, this study is a continuation for most people who have been doing well on DOR/ISL in previous MSD studies. You need to be at least 18 years old to take part, and the study is open to both men and women.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you currently taking the DOR/ISL medicine as part of a Merck Sharp & Dohme (MSD) sponsored HIV study (codes MK-8591A-018, -020, or -033)?
Did you have good control of your HIV-1 virus (less than 200 copies/mL) while on DOR/ISL in your previous study?
Did you avoid stopping DOR/ISL in your previous study because of low immune cell counts (CD4+ T-cells or lymphocytes)?
Were you NOT in study MK-8591A-019, or study -033 as a 'heavily treatment-experienced' participant?
Are you able to attend regular clinic visits and have blood tests?

Answer every question to see your result.

What does participation involve?

If you join this study, you will continue to take the DOR/ISL medicine you are already receiving. The main purpose of your involvement will be for the study team to regularly check on your health and how you are tolerating the medicine. This will usually involve regular visits to the clinic for medical examinations, blood tests, and to answer questions about any side effects you might be experiencing or how you are generally feeling. They will also look at how your HIV-1 levels are doing. The study team will explain how often these visits will be needed and for how long the study will continue.

Potential risks and benefits

Taking part in this study means you'll continue to receive your current HIV treatment, DOR/ISL, under close medical supervision, which could be beneficial. The doctors and nurses will monitor your health regularly. However, like all medicines, DOR/ISL can have side effects, and some people may experience them. The study aims to gather more information on these. You'll be fully informed about any known risks before you decide to take part. Remember, you can choose to leave the study at any time, for any reason, without it affecting your medical care.

Locations (95)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University of Alabama at Birmingham-UAB 1917 Research Clinic ( Site 3104)
Verified postcode
Birmingham, United States
Pueblo Family Physicians ( Site 3102)
Verified postcode
Phoenix, United States
Pacific Oaks Medical Group ( Site 3123)
Verified postcode
Beverly Hills, United States
Kaiser Permanente ( Site 3124)
Verified postcode
Los Angeles, United States
Ruane Clinical Research Group, Inc ( Site 3126)
Verified postcode
Los Angeles, United States
Mills Clinical Research ( Site 3114)
Verified postcode
Los Angeles, United States
University of California Davis Health-Internal Medicine: Infectious Diseases ( Site 3137)
Verified postcode
Sacramento, United States
Georgetown University Medical Center ( Site 3130)
Verified postcode
Washington D.C., United States
Therafirst Medical Center ( Site 3110)
Verified postcode
Fort Lauderdale, United States
Midway Immunology and Research Center ( Site 3117)
Verified postcode
Ft. Pierce, United States
AHF The Kinder Medical Group ( Site 3108)
Verified postcode
Miami, United States
Floridian Clinical Research, LLC ( Site 3133)
Verified postcode
Miami Lakes, United States

Common questions

What is HIV-1?

HIV-1 is a virus that affects your immune system, making it harder for your body to fight off infections. Medicines like DOR/ISL help to manage the virus.

What is DOR/ISL?

DOR/ISL is a combination tablet medicine used to treat HIV-1 infection. This study is checking its safety over time.

Why is this study being done?

This study is an important way to watch people who are already taking DOR/ISL to make sure it continues to be safe and well-tolerated in the long term.

Do I have to pay to be in the study?

No, you will not have to pay for the study medication or related medical care while you are part of the study.

Can I stop being in the study?

Yes, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.