Clinical trial

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

Recruiting now · Phase 3 · 1 countries · Registry ID NCT07075146

Recruiting nowPhase 3Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 70 Years

SexAll

Healthy volunteersNot accepted

ConditionHIV - Human Immunodeficiency Virus, Obesity, Overweight and/or Obesity

Full registry 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

Treatments and study arms

DOR/3TC/TDF

Drug

It is a triple-drug antiretroviral drug co-formulated in a single tablet. It contains Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate 100/300/300 mg

BIC/FTC/TAF

Drug

It is a triple-drug antiretroviral drug co-formulated in a single tablet. It contains bictegravir 50 mg, tenofovir alafenamide 25 mg, and emtricitabine 200 mg. It is the standard therapy.

Primary outcomes

To determine the safety and tolerability of Doravirine/Lamivudine/Tenofovir compared with Bictegravir/Tenofovir Alafenamide/Emtricitabine in ART-naive people living with HIV at 144 weeks of treatment.144 weeks

Number of participants with treatment-related adverse events as assessed of serious adverse events (WHO grade 3 or 4) for PWH treated with DOR/TDF/3TC or BIC/FTC/TAF at 144 weeks, expressed in proportions of new cases.

Evaluate the effectiveness and safety of Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF) compared with Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF)144 weeks of follow-up with interim analysis at 48 and 96 weeks

Effectiveness: Number of participants with viral load measurement (HIV-1 RNA) \<50 copies/mL at 144 weeks of follow-up for PWH treated with DOR/3TC/TDF or BIC/FTC/TAF,BIC/FTC/TAF at 144 weeks,

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Hospital de infectología, Centro Médico Nacional La Raza🇲🇽 Mexico City, Mexico

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José A Mata, Master degreeContact

Email · Call 525530379053

Ana C Díaz, postgraduateContact

José A Mata, M.ScPrincipal Investigator