RecruitingNCT03884673

Dolutegravir Plus Lamivudine Simplified Therapy

Real World Study: Dolutegravir Plus Lamivudine Simplified Therapy in Treatment Experienced HIV-1 Patients


Sponsor

Guangzhou 8th People's Hospital

Enrollment

300 participants

Start Date

Jan 1, 2019

Study Type

OBSERVATIONAL

Conditions

Summary

Dolutegravir (DTG) is one type of integrase inhibitor, lamivudine (3TC) is one type of reverse transcriptase inhibitor, both of which are HIV medicine prevents HIV from self-multiplying, reduces the viral load. The data of the existing randomized controlled clinical studies show that the simplified two-drug DTG-based regimen is similar to the three-drug regimen in terms of efficacy, but there are no relevant data and reports on the efficacy and safety of DTG+3TC in HIV-infected patients in China so far. This project aims to explore the efficacy and safety of the DTG + 3TC regimen for HIV-infected patients in real clinical environment, to guide clinical application, and to provide a theoretical basis for the selection of simplified schemes for the formulation of guidelines. This study was done to see if the combination of two anti-HIV medicines, dolutegravir (DTG, Tivicay) and lamivudine (3TC, Epivir) taken once a day, provide a safe, effective, and well-tolerated treatment for HIV.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether HIV-positive people who are stable on a standard three-drug antiretroviral regimen can safely switch to a simpler two-drug combination — dolutegravir plus lamivudine. The goal is to find a treatment option that is easier to take and may have fewer long-term side effects on the kidneys and bones. **You may be eligible if...** - You are over 18 years old and HIV-positive - You have been on a standard three-drug antiretroviral therapy for at least 24 weeks - Your doctor has decided you may benefit from switching to a simpler regimen, for reasons such as side effects, kidney problems, osteoporosis, or bone marrow suppression - You are willing to have your CD4 count monitored at regular intervals **You may NOT be eligible if...** - You are not currently on antiretroviral treatment - You have conditions that make the two-drug switch clinically unsafe 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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Interventions

DRUGDTG+ 3TC

It is a simplified therapy regimen study of dolutegravir combined with lamivudine for HIV-1 infected patients in the real world of China.


Locations(1)

Guangzhou 8th People's Hospital

Guangzhou, Guangdong, China

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NCT03884673


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