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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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.
• Email: jamatamarin@gmail.com
• Phone: 525530379053

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.