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

Launched by INSTITUTO MEXICANO DEL SEGURO SOCIAL · Jun 12, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how safe, tolerable, and effective two different HIV treatment options are for people who have just been diagnosed with HIV and have never taken antiretroviral medicines before. The two treatments being compared are called DTG/3TC and BIC/TAF/FTC. Researchers want to see not only how well these medicines control the virus but also how they affect things like weight and overall health, since some HIV medicines can cause weight gain that might increase the risk of heart problems over time.

People who might join the study are adults diagnosed with HIV who have never taken HIV prevention or treatment drugs before, have a certain level of the virus in their blood, and don’t have other serious health issues like metabolic syndrome, uncontrolled diabetes, or liver infections. If you join, you’ll be randomly assigned to start one of the two treatment plans, and your health will be closely monitored through regular check-ups and blood tests for up to nearly three years. The study takes place at a hospital in Mexico City, and participants will need to agree to take part and attend all scheduled visits. This trial aims to help doctors find the best first treatment for people living with HIV, balancing effectiveness and long-term safety.

Gender

ALL

Eligibility criteria

• 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