DTG/3TC versus BIC/TAF/FTC as first-line HIV treatment for people new to antiretrovirals

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

This trial will test whether DTG/3TC gives similar viral control but less weight gain and metabolic side effects than BIC/TAF/FTC in adults newly starting HIV treatment.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 124 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Instituto Mexicano del Seguro Social (Government)
• Locations: 1 site (Mexico City, Azcapotzalco)
• Trial ID: NCT07031063 on ClinicalTrials.gov

What this trial studies

This is an open-label, randomized Phase 4 comparison of two first-line antiretroviral regimens (DTG/3TC versus BIC/TAF/FTC) in treatment-naive adults with HIV seen at the Infectious Diseases Hospital, Centro Médico Nacional La Raza. Eligible participants will have baseline clinical assessment, labs (including viral load, CD4, glucose, lipids, liver and kidney tests) and body composition measured by segmental bioimpedance, then be randomized via a digital system to one of the two arms. The study will monitor viral suppression, safety, tolerability, weight and other metabolic outcomes over the planned enrollment/follow-up period. Data will be collected during routine clinic visits and analyzed for differences in effectiveness and metabolic adverse effects between the regimens.

Who should consider this trial

Good fit: Adults (≥18) with newly diagnosed HIV who are antiretroviral-naive, have HIV-1 RNA between 500 and 500,000 copies/mL, no prior PrEP/PEP, eGFR ≥30 mL/min/1.73 m2, and are treated at the IMSS Infectious Diseases Hospital La Raza who consent to participate.

Not a fit: People with metabolic syndrome, uncontrolled diabetes, hepatitis B or C coinfection, known resistance mutations to regimen components, contraindications to INSTIs, or who take interacting medications are excluded and likely would not benefit from participation.

Why it matters

Potential benefit: If successful, the results could identify a first-line option that controls HIV while causing less weight gain and reduced long-term metabolic risk.

How similar studies have performed: Large trials have shown both DTG/3TC and BIC/TAF/FTC provide strong viral suppression, but direct head-to-head data on comparative weight gain and metabolic effects are limited, so this comparison addresses a partly novel question.

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

Where this trial is running

Mexico City, Azcapotzalco

• Hospital de infectología, Centro Médico Nacional La Raza — Mexico City, Azcapotzalco, Mexico (Recruiting)

Study contacts

• Principal investigator: José A Mata, Master degree — Instituto Mexicano del Seguro Social
• Study coordinator: José A Mata, M.Sc.

Conditions HIV Infection; Metabolic Syndrome; Antiretroviral Treatment; HIV; dual-therapy; BIC/TAF/FTC; DTG/3TC; metabolic syndrome