Patients who developed metabolic syndrome after initiation of HIV treatment or with antiretroviral therapy (ART) for at least 36 months, treated with second generation integrase inhibitors (BIC/TAF/FTC, DTG/ABC/3Tc or DTG+TDF/FTC) who have gained at least 10% of their total body weight after starting ART, with a body mass index ≥25 kg/m2 and body fat greater than 20% will be eligible to participate in this clinical trial. If they decide to participate, they will sign an informed consent. After this, a mobile application will randomly decide whether the participant will continue with their ART regimen or switch to another ART (listed in the guidelines as one of the main lines of treatment) containing doravirine/lamivudine/disoproxil fumarate tenofovir. Medical visits will be at 1 month, 3 months, 6 months, 9 months, and 12 months after get in to this protocol, with laboratory studies that evaluate fats, blood sugar, liver function, kidney function, and test for HIV control; in addition, each visit will be given self-fillable scales to evaluate neuropsychiatric disorders such as depression, anxiety, insomnia, satisfaction with treatment or symptoms associated with it.The aim of the study is to observe whether there is weight loss with the change in HIV treatment.
Virologically suppressed for at least 48 weeks prior to study entry
Coming from a regimen containing Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF), Dolutegravir/Lamivudine/Abacavir (DTG/3TC/ABC), or, Dolutegravir/Tenofovir Disoproxil Fumarate/Emtricitabine (DTG+TDF/FTC) with no known failures to integrase inhibitors for al least 48 weeks.
BMI ≥25 kg/m2 at screening and
Unintentional weight gain of >10% from baseline (prior to INSTI initiation) within 1-3 years of starting INSTI ART, with no other apparent medical reason to explain the weight gain (concomitant medication use, Cushing's disease, recent prolonged hospitalization, etc.), in the opinion of the site investigator.
Loss of social security
Allergy to any of the components of ART, previously unknown.
Withdrawal of informed consent
Acquiring HBV and/or HCV infection during follow-up.
Parallel
Integrase inhibitor
DrugSecond generation integrase inhibitor 1) Bictegravir 50 mg/ alafenamide tenofovir 25 mg/ emtricitabine 200 mg (BIC/TAF/FTC); 2) Dolutegravir 50 mg/ abacavir 600 mg/ lamivudine 300 mg (DTG/ABC/3TC); 3) DTG 50mg+TDF 300mg/FTC 200mg (DTG+TDF/FTC) Each will be prescribed one tablet every day during 48 weeks
Doravirine + tenofovir DF + lamivudine
DrugIndividuals who meet the selection criteria will be randomized to maintain their same regimen with second-generation integrase inhibitors or switch to DOR/TDF/3TC 100/ 300/300 mg It will be prescribed one tablet every day during 48 weeks
Change in body weight and BMI
To determine the percentage change in body weight and BMI in virologically suppressed PLHIV maintaining a second-generation INSTI regimen compared with those switching to DOR/3TC/TDF at 48 weeks post-switch. This will be measured with with the same scale at baseline, 1 month, 3 months, 6 months, 9 months and 12 months.
Adverse events
Evaluate the number and degree of adverse events in each group of ART at baseline, 1 month, 3 months, 6 months, 9 months and 12 months post-recruitment
Evaluate neuropsychiatric disorders
Assess sleep quality using the Insomnia Severity Score (ISI) baseline and at 48 weeks Assess anxiety and depression using the Hospital Anxiety and Depression Scales (HADS-A and HADS-D) baseline and at 48 weeks Assess the presence and degree of depression using the Patient Health Questionnaire-9 (PHQ-9) baseline and at 48 weeks. This will be measured at baseline, 1 month, 3 months, 6 months, 9 months and 12 months.
Changes in lipid profile
Analyze changes in total cholesterol, hdl cholesterol and triglycerides at baseline and 48 weeks after switch. This will be evaluated at baseline, 1 month, 3 months, 6 months, 9 months and 12 months.
Analyze changes in body composition
Fat in percentage, muscle in kilograms, water in percentage and bone in kilograms. This will be evaluated with same bioimpedance equipment at baseline, 1 month, 3 months, 6 months, 9 months and 12 months.
HIVSDM scale symptom distress scale
Symptom distress an instrument to identify perceived individual symptoms reported by HIV infected patients. The construct distress, in an HIV population, is characterized by phenomena such as fatigue/low energy, fevers, dizziness, tingling/hand/foot pain, memory loss, nausea/vomiting, diarrhea, depression, anxiety, sleep problems, skin problems, cough/shortness of breath, headache, appetite loss, bloating/gas, muscle/joint pain, sexual problems, weight gain weight loss, and hair loss. This will be measured at baseline, 1 month, 3 months, 6 months, 9 months and 12 months.
HIV Treatment Satisfaction Questionnaire (HIVTSQ)
The HIV treatment Satisfaction Questionnaire is a Patient-reported questionnaire that assesses treatment satisfaction, specific to patients with HIV-1. Is a10-item self-answered where they are asked to respond to each of 10 questions, by circling a number (0-6), this will be measured at baseline, 1 month, 3, 6, 9 and 12 months after switch.
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