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Clinical trial Recruiting at 1 site Phase 3 Interventional Ages 18 to 70

Doravirine/TDF/3TC versus Bictegravir/FTC/TAF for adults with HIV who are overweight or obese

Official title: Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate COmpared With Bictegravir/Emtricitabine/Tenofovir Alafenamide in ART-Naïve People Living With HIV and Overweight or Obesity

Run by Instituto Mexicano del Seguro Social · NCT07075146 · Data updated 2026-11-12

This trial will test whether a doravirine-based HIV pill or a bictegravir-based HIV pill leads to less weight gain in adults with HIV who are overweight or obese starting antiretroviral therapy.

More Obesity trials

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years to 70 Years
SexAll
Enrollment306 (estimated)
SponsorInstituto Mexicano del Seguro Social
Government
Locations1 site (Mexico City)
StatusRecruiting
StartedMay 5, 2025
Main results expectedJune 5, 2026
Study endsAugust 1, 2028
Registry record updatedAugust 24, 2025
Trial IDNCT07075146 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (≥18) living with HIV who are ART‑naïve, have BMI ≥25 kg/m² and >20% body fat, HIV‑1 RNA ≥1000 copies/mL, and meet safety labs (GFR ≥60 mL/min, ALT/AST <90 IU/L) would be eligible to participate.

Probably not a fit

People with uncontrolled diabetes, active hepatitis B or C, recent bariatric surgery, significant kidney impairment (GFR <60 mL/min), recent use of weight‑affecting drugs, or prior ART use are unlikely to be eligible or to gain benefit from this comparison.

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

What this trial studies

ART-naïve adults with HIV and BMI ≥25 kg/m² are assigned to receive either DOR/3TC/TDF or BIC/FTC/TAF and followed longitudinally for clinical, virologic, safety, and body composition outcomes. Visits include repeated laboratory testing, HIV viral load and CD4 counts, vital signs, anthropometrics, and segmental bioimpedance measurements at scheduled intervals up to 144 weeks. The trial compares weight change, body fat distribution, viral suppression, and adverse events between the two approved ART regimens. Statistical comparisons and longitudinal analyses will be used to detect differences in metabolic and tolerance outcomes over time.

Why it matters

Potential benefit: If successful, results could help clinicians choose an HIV regimen that minimizes weight gain and long-term metabolic risks for people with HIV who are overweight or obese.

How similar studies have gone: Prior research has shown that integrase inhibitor regimens such as bictegravir are often associated with greater weight gain, while doravirine-containing regimens have shown smaller weight changes in some reports, though direct head‑to‑head Phase 3 comparisons are limited.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Adults (≥18 years) with confirmed HIV diagnosis, ART-naïve
2. Signed informed consent
3. HIV-1 RNA ≥1000 copies/mL
4. No history of PrEP or PEP failure
5. BMI ≥25 kg/m² and body fat \>20%
6. Stable treatment for dyslipidemia (if applicable)
7. No planned medication changes affecting weight
8. Willingness to adhere to assigned ART
9. Recent HIV-1 RNA and CD4+ results
10. GFR (CKD-EPItip) ≥60 mL/min
11. ALT and AST \<90 IU/L
12. Willingness to report dietary or physical activity changes during follow-up Non-Inclusion Criteria

1\. Uncontrolled diabetes 2. Recent changes in insulin or hypoglycemic drugs (\<3 months) 3. Active malignancy 4. History of bariatric surgery 5. Allergies to study drugs 6. Hepatitis B and/or C coinfection 7. GFR \<60 mL/min (CKD-EPI) 8. Drug interactions with ART regimens 9. Recent (60 days) use of anorectic drugs 10. Recent (30 days) hospitalization for severe illness 11. Unstable hypothyroidism

Exclusion Criteria:

1. Loss of social security coverage
2. Newly discovered allergy to study drugs
3. Withdrawal of consent
4. Hepatitis B or C infection acquired during follow-up
5. Use of psychiatric or thyroid medications without a stable dose for ≥12 weeks
6. Initiation or discontinuation of medications affecting weight after enrollment
7. Unplanned bariatric surgery

Where it's running

  • Hospital de infectología, Centro Médico Nacional La Raza
    Mexico City, Mexico     Recruiting

Study contacts

  • Principal investigator: José A Mata, M.Sc — Instituto Mexicano del Seguro Social
  • Study coordinator: José A Mata, M.Sc
  • Email: jamatamarin@gmail.com
  • Phone: 525530379053

Similar studies

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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.
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HIV (Human Immunodeficiency Virus) 16Obesity 1426Overweight and/or Obesity 16Instituto Mexicano del Seguro Social 9
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.