NCT07075146 DOR/TDF/3TC COmpared With BIC/FTC/TAF in ART-Naïve People Living With HIV and Overweight or Obesity
| NCT ID | NCT07075146 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | José Antonio Mata Marín |
| Condition | HIV - Human Immunodeficiency Virus |
| Study Type | INTERVENTIONAL |
| Enrollment | 306 participants |
| Start Date | 2025-05-05 |
| Primary Completion | 2026-06-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 306 participants in total. It began in 2025-05-05 with a primary completion date of 2026-06-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Background:Historically, HIV infection was associated with significant weight loss. However, weight gain is now commonly observed after initiating antiretroviral therapy (ART), particularly in individuals underweight at baseline. It remains unclear whether this weight gain reflects a "return to health" or results from drug-related or metabolic effects, and whether it persists beyond immune restoration. Recent evidence indicates that ART regimens containing second-generation integrase strand transfer inhibitors (INSTIs), such as bictegravir combined with tenofovir alafenamide, are associated with greater weight gain compared to other antiretroviral combinations, raising concerns about potential long-term metabolic consequences.Objective:To evaluate the effectiveness, safety, and tolerability of Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF) compared with Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) in ART-naïve people living with HIV (PWH) who are overweight or obese.Materials and Methods:This open-label, randomized clinical trial, approved by the Ethics and Scientific Research Committee (No. 3502), will be conducted at the Infectious Diseases Hospital of the National Medical Center "La Raza" from May 2025 to May 2027. ART-naïve PWH, recently diagnosed, with no prior use of pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP), who do not require hospitalization, and have a body mass index (BMI) ≥25 kg/m² and body fat \>20%, will be invited to participate. Participants will provide written informed consent and be randomized 1:1 to receive either DOR/3TC/TDF or BIC/FTC/TAF.
Eligibility 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
Contact & Investigator
José A Mata, M.Sc
PRINCIPAL INVESTIGATOR
Instituto Mexicano del Seguro Social
Frequently Asked Questions
Who can join the NCT07075146 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying HIV - Human Immunodeficiency Virus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07075146 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 306 participants.
Is NCT07075146 currently recruiting?
Yes, NCT07075146 is actively recruiting participants. Contact the research team at jamatamarin@gmail.com for enrollment information.
Where is the NCT07075146 trial being conducted?
This trial is being conducted at Mexico City, Mexico.
Who is sponsoring the NCT07075146 clinical trial?
NCT07075146 is sponsored by José Antonio Mata Marín. The principal investigator is José A Mata, M.Sc at Instituto Mexicano del Seguro Social. The trial plans to enroll 306 participants.
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