RECRUITINGPhase 4INTERVENTIONAL

Safety, Tolerability and Effectiveness of DTG/3TC vs BIC/TAF/FTC in PWH Without Antiretroviral Experience

Safety, Tolerability and Effectiveness of DOlutegravir/Lamivudine Compared With Bictegravir/Tenofovir Alafenamide/Emtricitabine in People Living With HIV Without Antiretroviral Experience (TEOTL)

About This Trial

Background: The primary goal of antiretroviral therapy is to prevent HIV-associated morbidity and mortality. The effectiveness of first-line regimens is supported by a large number of clinical trials; current concerns focus on the long-term adverse effects of antiretrovirals, especially integrase strand transfer inhibitors, as they have been associated with significant weight gain, which may be associated with increased cardiovascular risk. Objective: To determine the effectiveness, safety, and tolerability of Dolutegravir/Lamivudine (DTG/3TC) compared with Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/TAF/FTC) in treatment-naive people living with HIV (PWH). Materials and methods: With prior approval from the Ethics and Scientific Research Committee 3502, an open-label, randomized clinical trial will be conducted at the Infectious Diseases Hospital of the National Medical Center "La Raza" from November 2024 to May 2026. Recently diagnosed PWH with no history of PrEP and/or PeP use, without hospitalization criteria, and without a diagnosis of metabolic syndrome based on ATP-III criteria will be identified. They will be invited to participate in the study and, if they accept, they will sign an informed consent form. They will be randomized to start a BIC/TAF/FTC or DTG/3TC 1:1 regimen. Laboratory studies, vital signs, and somatometry including bioimpedance will be performed at 4, 12, 24, 36, 48, 72, 96, 120, 144 weeks of follow-up; viral load and CD4+ count will be measured at weeks 12, 24, 48, 72, 96, 120, 144 weeks after the start of treatment. Sampling will be non-probabilistic; the distribution will be identified using the Kolmogorov-Smirnoff test, and measures of central tendency and percentages will be expressed. Comparisons will be made using the Mann-Whitney U test. Qualitative data will be analyzed using the x2 or Fisher's exact test. Group analysis will be performed at 12, 24, 48, 96 and 144 weeks using the Wilcoxon test. A P value ≤0.05 with a 95% confidence interval will be considered statistically significant.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Men and women ≥18 years of age , diagnosed with HIV, and naive to antiretroviral treatment. 2. HIV-1 RNA quantified by RT-PCR ≥500 and less than 500,000 copies/mL. 3. No history of PrEP or PEP use. 4. Estimated glomerular filtration rate ≥30 mL/min/1.73 m2 SC. 5. No current or planned use of medications associated with significant weight changes during the study period. 6. Be a beneficiary of the Mexican Social Security Institute treated at the Infectious Diseases Hospital, La Raza National Medical Center. 7. Willingness of the participant to give consent. Who Should NOT Join This Trial: 1. Diagnosis of metabolic syndrome. 2. uncontrolled diabetes 3. Contraindication to the use of INSTIs. 4. Known mutations in any of the components of either regimen (second-generation INSTIs, 3TC/FTC, or TAF). 5. Co-medications that have potential interactions with any of the components of the antiretroviral regimens. 6. Coinfection with hepatitis B or hepatitis C virus. 7. High cardiovascular risk (Framinham \>20% or AHA/ACC \>7.5%). 8. Use of recreational drugs with anorexigenic potential (crystal, methamphetamines, cocaine) 60 days prior to randomization. 9. Hospitalization for acute or severe illness 30 days prior to randomization Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Men and women ≥18 years of age , diagnosed with HIV, and naive to antiretroviral treatment. 2. HIV-1 RNA quantified by RT-PCR ≥500 and less than 500,000 copies/mL. 3. No history of PrEP or PEP use. 4. Estimated glomerular filtration rate ≥30 mL/min/1.73 m2 SC. 5. No current or planned use of medications associated with significant weight changes during the study period. 6. Be a beneficiary of the Mexican Social Security Institute treated at the Infectious Diseases Hospital, La Raza National Medical Center. 7. Willingness of the participant to give consent. Exclusion Criteria: 1. Diagnosis of metabolic syndrome. 2. uncontrolled diabetes 3. Contraindication to the use of INSTIs. 4. Known mutations in any of the components of either regimen (second-generation INSTIs, 3TC/FTC, or TAF). 5. Co-medications that have potential interactions with any of the components of the antiretroviral regimens. 6. Coinfection with hepatitis B or hepatitis C virus. 7. High cardiovascular risk (Framinham \>20% or AHA/ACC \>7.5%). 8. Use of recreational drugs with anorexigenic potential (crystal, methamphetamines, cocaine) 60 days prior to randomization. 9. Hospitalization for acute or severe illness 30 days prior to randomization

Treatments Being Tested

DRUG

DTG/3TC

Dual therapy of 2 drugs co-formulated in 1 tablet: Dolutegravir 50 mg/ lamivudine 300 mg, it is the experimental group

DRUG

Bictegravir (BIC) plus Emtricitabine (FTC) plus Tenofovir Alafenamide (TAF)

It is a triple-drug antiretroviral drug co-formulated in a single tablet. It contains bictegravir 50 mg, tenofovir alafenamide 25 mg, and emtricitabine 200 mg. It is the standard therapy.

Locations (1)

Hospital de infectología, Centro Médico Nacional La Raza

Mexico City, Azcapotzalco, Mexico