Dolutegravir Plus Lamivudine Simplified Therapy

Study Overview
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Brief Summary
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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.

Detailed Description
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This study is an open-label, multicentered, single-arm and phase IV clinical trial. 300 HIV-infected patients who received simplified treatment regimen (50mg DTG+ 400mg 3TC, oral, qd) were selected to observe the treatment efficacy. At week 24, 36, 48 and 96, the rate of viral suppression and CD4 cell count were calculated against baseline. In addition, the safety and drug compliance were also monitored.

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

Conditions
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HIV/AIDS

Intervention / Treatment
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* Drug: DTG+ 3TC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age (> 18 years), male and female; HIV-1 infected; Using a standard three-drug-based regimen for at least 24 weeks. Based on clinical decision making* decide if patients can be treated with the DTG+3TC simplified scheme for a variety of reasons, such as (but not limited to): patients cannot tolerate the conventional three-drug treatment scheme, renal insufficiency, osteoporosis, bone marrow suppression and for other reasons patients cannot use the conventional three-drug treatment scheme; Initial HIV-1 RNA viral load and CD4 cell count were unlimited. CD4 can be monitored at least three times in the first year (including baseline, 24 weeks of treatment and 48 weeks of treatment). After the first year, CD4 can be detected at least once every six months. State Informed Consent for Free Treatment has been signed; Good compliance and signing Informed Consent (* Reference criteria: Refer to APSIRE study, creatinine clearance rate (> 50 mL/min), no DTG/3TC allergy history, HBsAg negative, no chronic liver disease, no severe liver damage, no pregnancy during the study) Exclusion Criteria: Has participated in other clinical trials of HIV vaccine or other drug trials in the past three months; Researchers decide if patients could/not complete the scheduled follow-up (factors to consider such as weak, poor compliance, etc.). Has a clear history of DTG or 3TC allergy; HBsAg and/or HBV-DNA positive; Pregnancy during the study period.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| DTG+3TC<br>These cases were given simplified therapy regimen including DTG (50 mg, oral,qd) combined with 3TC (300 mg,oral,qd). | Drug: DTG+ 3TC<br>* It is a simplified therapy regimen study of dolutegravir combined with lamivudine for HIV-1 infected patients in the real world of China.<br>* Other names: A simplified therapy regimen;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Virus suppression rate | ratio of HIV RNA < 50 copies/mL at 48 and 96 weeks of treatment | 96 weeks | 
| Adverse events | Rate of adverse events reported during the observational period | 96 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The immunological ability (CD4+) | CD4 cell count (baseline to 48 weeks and 96 weeks) | 96 weeks | 
| Drug compliance | To explicit the number of people who have completed the treatment | 96 weeks | 
| The immunological ability (CD8+) | CD4 +/ CD8 + ratio (baseline to 48 weeks and 96 weeks) | 96 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DTG + 3TC Simplified Therapy, Simplified Therapy Regimen, Real World Study, HIV-1-infected patients