DOR/TDF/3TC COmpared With BIC/FTC/TAF in ART-Naïve People Living With HIV and Overweight or Obesity

Recruiting now · Phase 3

Conditions studied: HIV - Human Immunodeficiency Virus, Obesity, Overweight and/or Obesity

In brief

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.

Key facts

Study ID

NCT07075146

Run by

José Antonio Mata Marín

People needed

306

Starts

2025-05-05

Expected to finish

2028-08-01

Last updated by the study team

2025-08-24

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

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

Full record on ClinicalTrials.gov

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