RecruitingPhase 3NCT04892654

Efficacy of Doravirine + Dolutegravir Dual Therapy in the Context of Antiretroviral Therapy Switch

Efficacy of Doravirine + Dolutegravir Dual Therapy in the Context of Antiretroviral Therapy Switch (DORDOL)

Sponsor

Chelsea and Westminster NHS Foundation Trust

Enrollment

150 participants

Start Date

Aug 17, 2022

Study Type

INTERVENTIONAL

Conditions

HIV-1-infection

Summary

Combination antiretroviral therapy (cART) HIV treatments are associated with increased quality of life, and a normalisation of life expectancy in people living with HIV. However, long-term use of cART can lead to side-effects through exposure to drug-related toxicity. For this reason researchers are interested in looking at alternative therapies that might expose patients to fewer and less severe side effects while providing the same quality of care as antiretroviral therapies most often used to treat HIV. The purpose of this study is to investigate if the study drug combination that is being tested (doravirine + dolutegravir) is safe compared with other triple cART regimens.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether switching HIV-positive people who are already well-controlled on three-drug antiretroviral therapy to a simpler two-drug combination (doravirine + dolutegravir) is just as effective and safe. Reducing the number of drugs may lower side effects and simplify treatment. **You may be eligible if...** - You are 18 or older and living with HIV-1 - You have been on stable, effective three-drug HIV treatment for at least 6 months with an undetectable viral load - You have no resistance to either doravirine or dolutegravir (the two new drugs) - Women of childbearing potential who are sexually active must be using a reliable form of contraception (implant, injection, IUD, or oral hormones) **You may NOT be eligible if...** - You have a history of HIV treatment failure involving drugs similar to doravirine or dolutegravir (without resistance testing showing sensitivity) - You take medications that are incompatible with these two drugs - You have very low blood counts, severe kidney disease, or high liver enzymes - You have active or chronic hepatitis B or C (with limited exceptions) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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