Real Life Study of Dolutegravir Plus Lamivudine in HIV-1-Infected Treatment-Naive Patients

Study Overview
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Brief Summary
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Thanks to the actual highly active antiretroviral therapy (HAART) patients living with HIV have a better life expectancy, becoming chronical patients. Today's antiretroviral treatment (ART) must be maintained for life to prevent disease progression until a cure is reached. Given this need, ARTs are becoming safer and more effective but are still toxic. Cause of that simplification therapies are real, reducing the number of different Antiretrovirals involved controlling the infection. This strategies include from monotherapy using/with protease inhibitors (PI), which was investigated with treatment-experienced patients and virologically suppressed, to dual therapies which recently were investigated in treatment-naïve and treatment-experienced patients with combinations such as dolutegravir (DTG) plus lamivudine (3TC), Dolutegravir plus rilpivirine or rilpivirine plus darunavir/ritonavir boosted. Nowadays dual therapy in real life (not into the context of a clinical trial) with dolutegravir plus lamivudine is largely studied in treatment-experienced patients who are virologically suppressed and got nearly a 100% efficacy results. Recently published results from clinical trials in treatment-naïve patients GEMINI 1 &2, where efficacy of the dual therapy with DTG 50mg plus 3TC 300mg/QD was compared versus the efficacy of triple therapy with tenofovir disoproxil fumarate, emtricitabine and dolutegravir (TDF/FTC+ DTG) (QD). Both trials show similar efficacy results, with virologic suppression higher than 90% at week 48. Clinical trials are the gold standard to approve and add to the clinical practice new drugs and new therapies, but is also known that have some inconvenient like strict inclusion-exclusion criteria which put the study population far from being a real sample. Studies with real world data (RWD) have several strengths such as quality in medical attention and works like a bridge between clinical trials and standard clinical care, reducing/lowering general costs, improving results and accelerating the generation of knowledge. For all the reasons above, the primary objective of this study is to analyze in treatment-naïve HIV patients the effectiveness in real life of 3TC (300 mg p.o. q 24 h) plus DTG (50 mg p.o. q 24 h). Secondary objectives are: to describe the patient who receive this dual therapy, to quantify the time gap between the clinic visit and the first dose of dual therapy administrated evaluating this dual therapy as candidate to test and treat therapies; to analyze the viral load drop and the increase of cluster of differentiation 4 (CD4) T lymphocytes levels; To analyze virological failures and previous mutations influence in basal resistance tests; and finally a pharmacoeconomic analysis, safety of the treatment and adherence to the healthcare system.

Official Title
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Real Life Study of Dolutegravir Plus Lamivudine in HIV-1-Infected Treatment-Naive Patients

Conditions
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HIV-1-infection

Intervention / Treatment
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* Drug: Dolutegravir 50mg Tab
* Drug: Lamivudine 300 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HIV-1 infected adults (<17 y.o.) Antiretroviral-naïve. Be able to comply with protocol requirements and instructions. Subject or the subject's representative capable of giving signed informed consent. Exclusion Criteria: Women who are breastfeeding or plan to become pregnant during the study. Patients who in the investigator's judgment, poses a significant drop out risk or life expectancy inferior to study ending. Patients with anticipated need to change the ART before study ending.

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 |
| --- | --- |
| HIV-1 ART-Naive<br>Lamivudine (300 mg p.o. q 24 h) plus Dolutegravir (50 mg p.o. q 24 h) | Drug: Dolutegravir 50mg Tab<br>* The subjects starts their ART with this drugs, once a day<br>Drug: Lamivudine 300 mg<br>* The subjects starts their ART with this drugs, once a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects with plasma HIV 1 RNA <50 copies/milliliter at week 48 | The proportion of subjects with viral suppression (HIV-1 RNA <50 copies/mL) among subjects who received at least one dose of study medication | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in lymphocytes cell counts at week 24 and 48 |  | Baseline, 24 weeks and 48 weeks | 
| Number of Participants With Any Adverse Event (AE) | An AE is any untoward medical occurrence in a clinical investigation participant | 48 weeks | 
| Number of Participants Who Discontinue Treatment |  | 48 weeks |