Doravirine/TDF/3TC versus Bictegravir/FTC/TAF for adults with HIV who are overweight or obese
Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate COmpared With Bictegravir/Emtricitabine/Tenofovir Alafenamide in ART-Naïve People Living With HIV and Overweight or Obesity
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.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 306 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Instituto Mexicano del Seguro Social Government |
| Locations | 1 site (Mexico City) |
| Trial ID | NCT07075146 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Mexico City
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.