Evaluation of Switch to Dolutegravir/Lamivudine (DTG/3TC) From Current Suppressive Antiretroviral Therapy in People Living With HIV (PLWH) Receiving Opioid Agonist Therapy (OAT)
This study is for people living with HIV who are also taking medication for opioid addiction, like methadone or buprenorphine. We're testing a new HIV medicine called Dovato (which is Dolutegravir/Lamivudine). The main goal is to check if Dovato keeps the HIV virus suppressed (under control) when people switch from their usual HIV treatment. We also want to find out about any side effects from Dovato, if it affects their opioid addiction treatment doses, and how satisfied they are with the new medicine. We're especially interested in how Dovato works for people who might not have been studied much before, including those from Indigenous backgrounds, younger women, or those who use recreational drugs.
At a glance
What is this study about?
This study is for people living with HIV who are currently taking medication to help manage opioid addiction. These medications might include treatments like methadone or buprenorphine. The study focuses on an HIV medicine called Dovato (you might hear its ingredients, Dolutegravir and Lamivudine, mentioned too). If you're currently taking other HIV medicines and your HIV is well controlled, this study looks at what happens if you switch to Dovato instead.
The main aim is to see if Dovato continues to keep your HIV under control after you switch from your current treatment. The researchers will also be carefully watching for any side effects and seeing if Dovato affects the doses of your opioid addiction medication. They'll also check how happy people are with Dovato compared to their previous HIV treatment.
This research is particularly important because there isn't much information yet about how Dovato works in people living with HIV who are also receiving opioid addiction treatment, especially for certain groups like younger women, people from Indigenous backgrounds, or those who might use recreational drugs. This study hopes to fill those gaps in our understanding.
Key takeaways
- Switching HIV medication to Dovato for people on opioid addiction treatment.
- Checking if Dovato keeps HIV under control.
- Monitoring for side effects and impacts on opioid addiction treatment.
- Study lasts for about 11 months with regular check-ups.
- Aims to learn more about Dovato for groups often understudied.
Who may be eligible?
To join this study, you need to be at least 18 years old and living with HIV-1. Your HIV must be well controlled, meaning the virus in your blood is at a very low level for at least three months. You also need to have been taking medication for opioid addiction (like methadone or buprenorphine) for at least three months and your doctor believes you are stable on this treatment.
There are several reasons you might not be able to join. For example, if you have certain liver or kidney problems, or if you're pregnant or planning to get pregnant. Also, if you have hepatitis B, or if you've had an allergic reaction to any ingredients in Dovato before, you wouldn't be able to take part. It's important that Dovato doesn't interfere with any other medicines you're taking.
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 or older?
- Do you have HIV-1 that is currently well controlled?
- Are you taking medication for opioid addiction (like methadone/buprenorphine) and stable on it for at least 3 months?
- Are you not pregnant or planning to become so?
- Do you not have certain liver or kidney issues, or hepatitis B?
- Have you never had a serious allergic reaction to ingredients in Dovato?
What does participation involve?
If you decide to take part in this study, you'll be switching from your current HIV medication to Dovato. During the study, which lasts for 48 weeks (about 11 months), you'll have regular appointments. At these appointments, you’ll complete several questionnaires about your health and how you're feeling. You'll also have blood tests, urine tests to check for certain substances, and a review of all your medications and any side effects you might be experiencing. You'll have an ECG (a heart check) at the start of the study and again at the end, and a physical exam. Your alcohol use will also be discussed. The study team will guide you through all these steps.
Potential risks and benefits
Locations (1)
- Saskatchewan Health AuthorityVerified postcodeRegina, Canada
Common questions
What is Dovato?
Dovato is an HIV medicine that contains two drugs, Dolutegravir and Lamivudine, in one tablet.
Why is this study important?
It helps us understand how Dovato works for people living with HIV who are also on opioid addiction treatment, especially those not often included in past studies.
Will I still take my opioid addiction medication?
Yes, you will continue your opioid addiction treatment as prescribed, and the study will check if Dovato affects its dosage.
What if I experience side effects?
The study team will carefully monitor you for any side effects and address them with you.
Can I leave the study if I change my mind?
Yes, you can leave the study at any point without it affecting your future medical care.
How to find out more
Jones Kalyniuk, MSc
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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